Overview

This trial is active, not recruiting.

Conditions dental adhesives/restorations performance, non-carious cervical lesions composite restorations performance
Treatments g1-control: futurabond®dc-se, g2-control: futurabond®dc pre-etching, g3: futurabond® u - er, g4: futurabond® u - se, g5: adhese® universal - er, g6: adhese® universal - se
Sponsor University Fernando Pessoa
Start date November 2015
End date April 2018
Trial size 38 participants
Trial identifier NCT02698371, EC/011/2015, FCS-UFP-2014-04-2015-07-19

Summary

The purpose is to evaluate/compare clinical effectiveness of dual cure (DC) all-in-one Self-Etch (Futurabond® DC (FBDC)) adhesive and multimode/universal (Futurabond® U (FU) and Adhese® Universal (AU)) adhesives, with or without selective enamel etching, in non-carious cervical lesions (NCCL), during 24th months, using Word Dental Federation (FDI) and United States Public Health Services (USPHS) criteria.

The null hypotheses are:

H0 - Bonding to NCCLs with DC-SE and SE-Universal adhesives with SE strategies will result in similar (no significant differences) clinical (aesthetic, functional and biologic) behaviour/performance in a period of 24th month evaluation; H0 - Bonding to NCCLs with DC-SE and SE-Universal adhesives with SE strategies will result in similar restorations (aesthetic, functional and biologic) success rates over 24th month evaluation; H0 - Bonding to NCCLs with DC-SE and SE-Universal adhesives with SE strategies will result in similar restoration retention rates in a period of 24th month evaluation; H0 - Bonding to NCCLs DC-SE with enamel pre-etching and Universal adhesives with ER adhesive strategy will result in similar (no significant differences) clinical (aesthetic, functional and biologic) behaviour/performance in a period of 24thmonth evaluation; H0 - Bonding to NCCLs DC-SE with enamel pre-etching and Universal adhesives with ER adhesive strategy will result in similar restorations (aesthetic, functional and biologic) success rates over 24th month evaluation; H0 - Bonding to NCCLs DC-SE with enamel pre-etching and Universal adhesives with ER adhesive strategy will result in similar restoration retention rates in a period of 24th month evaluation; H0 - Bonding to NCCLs with FBDC or FU (DC adhesives) and AU (Light-curing adhesive) with SE or ER adhesive strategies will result in similar (no significant differences) clinical (aesthetic, functional and biologic) behaviour/performance in a period of 24th month evaluation; H0 - Bonding to NCCLs with FBDC or FU (DC adhesives) and AU (Light-curing adhesive) with SE or ER adhesive strategies will result in similar restorations (aesthetic, functional and biologic) success rates over 24th month evaluation; H0 - Bonding to NCCLs with FBDC or FU (DC adhesives) and AU (Light-curing adhesive) with SE or ER adhesive strategies will result in similar restoration retention rates in a period of 24th month evaluation; H0 - FDI or USPHS criteria evaluation outcomes not differ for the same data.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model factorial assignment
Masking double blind (subject, caregiver, outcomes assessor)
Arm
(Active Comparator)
Activation of the SingleDose blister FBDC DC (between thumb and forefinger and press on the part of the blister marked "press here" in blue). This injects Liquid 1 into Liquid 2 in the dispensing bay in a 1:1 ratio. Pierce the foil of the dispensing bay with the Single Tim, enlarge the hole with a circular movement and stir well to create a homogeneous mixture. Futurabond DC will be applied as thickness to the enamel/dentine and rub into the tooth surface for 20s; Drying of the adhesive layer for at least 5s with an air syringe; This adhesive layer will be light-cured with a light emitting diode unit (LED light), with an intensity of 1000mW/cm2, during 10s.
g1-control: futurabond®dc-se Futurabond®DC-SE
1st Appointment-Intervention: Initial intra-oral/cavity surface and tooth digital photography; Teeth anaesthesia with 3% mepivacaine (Scandinibsa, Sintra Business Park, Portugal); Operatory field isolation with cotton rolls and retraction floss (Ultradent). All cavities cleaned with pumice and water in a rubber cup, followed by rinsing and drying. Selection composite colour by shade guide; Adhesive interventions according to G1 arm assignment. Adhesive systems will be used as SingleDose mode. Composite restorations (AdmiraFusion Universal nano-hybrid composite) with incremental filling technique (two increments maximum), light-cured (LED Unit) with an intensity of 1000mW/cm2, during 40 seconds. Restorations will be finished immediately with diamond disks (OptiDisc® medium 40μm; Kerr) and burns. Polishing performed with diamond-impregnated silicone polishers (Dimanto, Voco, CuxHaven) during 10 seconds. Intra-oral digital photography of the restoration.
(Active Comparator)
Etch with 36% phosphoric acid, during 30s in enamel structures. Remove the 36% phosphoric acid with water during 1 minute (m). The remove of water excess will be done with weak air spray, not to dry the dentine completely. The dentine surface must slightly remain wet. Application of FBDC as an all-in-one self-etch adhesive approach simultaneously in dentin and enamel structures.
g2-control: futurabond®dc pre-etching Futurabond®DC pre-etching
1st Appointment-Intervention: Initial intra-oral/cavity surface and tooth digital photography; Teeth anaesthesia with 3% mepivacaine (Scandinibsa, Sintra Business Park, Portugal); Operatory field isolation with cotton rolls and retraction floss (Ultradent). All cavities cleaned with pumice and water in a rubber cup, followed by rinsing and drying. Selection composite colour by shade guide; Adhesive interventions according to G2 arm assignment. Adhesive systems will be used as SingleDose mode. Composite restorations (AdmiraFusion Universal nano-hybrid composite) with incremental filling technique (two increments maximum), light-cured (LED Unit) with an intensity of 1000mW/cm2, during 40 seconds. Restorations will be finished immediately with diamond disks (OptiDisc® medium 40μm; Kerr) and burns. Polishing performed with diamond-impregnated silicone polishers (Dimanto, Voco, CuxHaven) during 10 seconds. Intra-oral digital photography of the restoration.
(Experimental)
Application in enamel and dentin as an etch-and-rinse approach. Etching of the dental hard tissue phosphoric acid (during 15s in dentin and 30s in enamel structures; Aspirate the acid-etch agent, rinse with water for approx. 1 min. Dry off excess moisture with a gentle stream of air. Activating Futurabond U SingleDose (blister between thumb and forefinger and, by pressing on the area marked "press here", allow the liquid contained in the blister to flow into the mixing and dispensing chamber. Position the enclosed Single Tim applicator in the centre of the coloured circle in order to pierce through the film of the mixing and dispensing chamber. By stirring thoroughly with the applicator, create a homogeneous streak-free mixture of the two liquids). FU adhesive will be homogeneously applied to all cavity surfaces and rub in for 20s using the Single Tim; This adhesive layer will be light-cured with a light emitting diode unit, with an intensity of 1000mW/cm2 during 10s.
g3: futurabond® u - er Futurabond® U - self-etch
1st Appointment-Intervention: Initial intra-oral/cavity surface and tooth digital photography; Teeth anaesthesia with 3% mepivacaine (Scandinibsa, Sintra Business Park, Portugal); Operatory field isolation with cotton rolls and retraction floss (Ultradent). All cavities cleaned with pumice and water in a rubber cup, followed by rinsing and drying. Selection composite colour by shade guide; Adhesive interventions according to G3 arm assignment. Adhesive systems will be used as SingleDose mode. Composite restorations (AdmiraFusion Universal nano-hybrid composite) with incremental filling technique (two increments maximum), light-cured (LED Unit) with an intensity of 1000mW/cm2, during 40 seconds. Restorations will be finished immediately with diamond disks (OptiDisc® medium 40μm; Kerr) and burns. Polishing performed with diamond-impregnated silicone polishers (Dimanto, Voco, CuxHaven) during 10 seconds. Intra-oral digital photography of the restoration.
(Experimental)
application in enamel and dentin as an self-etch approach; Activating Futurabond U SingleDose (blister between thumb and forefinger and, by pressing on the area marked "press here", allow the liquid contained in the blister to flow into the mixing and dispensing chamber. Position the enclosed Single Tim applicator in the centre of the coloured circle in order to pierce through the film of the mixing and dispensing chamber. Expand the opening to its maximum size using a circular motion. By stirring thoroughly with the applicator, create a homogeneous, streak-free mixture of the two liquids). FU adhesive will be homogeneously apply to all cavity surfaces and rub in for 20 s using the Single Tim; Dry off the adhesive layer with dry, oil-free air for at least 5 s in order to remove any solvents. This adhesive layer will be light-cured with a light emitting diode unit (LED light), with an intensity of 1000mW/cm2, during 10 seconds.
g4: futurabond® u - se Futurabond® U - self-etch
1st Appointment-Intervention: Initial intra-oral/cavity surface and tooth digital photography; Teeth anaesthesia with 3% mepivacaine (Scandinibsa, Sintra Business Park, Portugal); Operatory field isolation with cotton rolls and retraction floss (Ultradent). All cavities cleaned with pumice and water in a rubber cup, followed by rinsing and drying. Selection composite colour by shade guide; Adhesive interventions according to G4 arm assignment. Adhesive systems will be used as SingleDose mode. Composite restorations (AdmiraFusion Universal nano-hybrid composite) with incremental filling technique (two increments maximum), light-cured (LED Unit) with an intensity of 1000mW/cm2, during 40 seconds. Restorations will be finished immediately with diamond disks (OptiDisc® medium 40μm; Kerr) and burns. Polishing performed with diamond-impregnated silicone polishers (Dimanto, Voco, CuxHaven) during 10 seconds. Intra-oral digital photography of the restoration.
(Experimental)
application in enamel and dentin as an etch-and-rinse approach; Etching of the dental hard tissue phosphoric acid (during 15 seconds in dentin and 30 seconds in enamel structures; Aspirate the acid-etch agent, rinse with water for approx. 1 minute. Dry off excess moisture with a gentle stream of air. Keep dentin dry, do not over dry; Starting with the enamel, thoroughly coat the tooth surfaces (enamel and dentin) to be treated with AU; Adhesive will be scrubbed into the tooth surface for at least 20 seconds. Adhesive will be dispersed with compressed air until a glossy, immobile film layer results. Light-curing for 10 s with a light emitting diode unit (LED light), with an intensity of 1000mW/cm2.
g5: adhese® universal - er Adhese® Universal - etch-and-rinse
1st Appointment-Intervention: Initial intra-oral/cavity surface and tooth digital photography; Teeth anaesthesia with 3% mepivacaine (Scandinibsa, Sintra Business Park, Portugal); Operatory field isolation with cotton rolls and retraction floss (Ultradent). All cavities cleaned with pumice and water in a rubber cup, followed by rinsing and drying. Selection composite colour by shade guide; Adhesive interventions according to G5 arm assignment. Adhesive systems will be used as SingleDose mode. Composite restorations (AdmiraFusion Universal nano-hybrid composite) with incremental filling technique (two increments maximum), light-cured (LED Unit) with an intensity of 1000mW/cm2, during 40 seconds. Restorations will be finished immediately with diamond disks (OptiDisc® medium 40μm; Kerr) and burns. Polishing performed with diamond-impregnated silicone polishers (Dimanto, Voco, CuxHaven) during 10 seconds. Intra-oral digital photography of the restoration.
(Experimental)
application in enamel and dentin as an self-etch approach; Starting with the enamel, thoroughly coat the tooth surfaces (enamel and dentin) to be treated with AU; Adhesive will be scrubbed into the tooth surface for at least 20 seconds. Adhesive will be dispersed with compressed air until a glossy, immobile film layer results. Light-curing for 10 s with a light emitting diode unit (LED light), with an intensity of 1000mW/cm2.
g6: adhese® universal - se Adhese® Universal - self-etch
1st Appointment-Intervention: Initial intra-oral/cavity surface and tooth digital photography; Teeth anaesthesia with 3% mepivacaine (Scandinibsa, Sintra Business Park, Portugal); Operatory field isolation with cotton rolls and retraction floss (Ultradent). All cavities cleaned with pumice and water in a rubber cup, followed by rinsing and drying. Selection composite colour by shade guide; Adhesive interventions according to G6 arm assignment. Adhesive systems will be used as SingleDose mode. Composite restorations (AdmiraFusion Universal nano-hybrid composite) with incremental filling technique (two increments maximum), light-cured (LED Unit) with an intensity of 1000mW/cm2, during 40 seconds. Restorations will be finished immediately with diamond disks (OptiDisc® medium 40μm; Kerr) and burns. Polishing performed with diamond-impregnated silicone polishers (Dimanto, Voco, CuxHaven) during 10 seconds. Intra-oral digital photography of the restoration.

Primary Outcomes

Measure
clinical performance of dental adhesives/restoration, graded on a 5-point scale, using FDI criteria
time frame: 24 months
clinical performance of dental adhesives/restoration, graded on a 4-point scale, using USPHS criteria
time frame: 24 months

Secondary Outcomes

Measure
Surface Luster, graded on a 5-point scale (FDI criteria)
time frame: 24 months
Staining margin, graded on a 5-point scale (FDI criteria)
time frame: 24 months
Colour stability and translucency, graded on a 5-point scale (FDI criteria)
time frame: 24 months
Fractures and Retention, graded on a 5-point scale (FDI criteria)
time frame: 24 months
Marginal Adaptation, graded on a 5-point scale (FDI criteria)
time frame: 24 months
Postoperative Hypersensibility, tooth vitality, graded on a 5-point scale (FDI criteria)
time frame: 24 months
Recurrence of Caries, erosion, abfraction, graded on a 5-point scale (FDI criteria)
time frame: 24 months
Tooth integrity (enamel cracks), graded on a 5-point scale (FDI criteria)
time frame: 24 months
Surface Staining, graded on a 3-point scale (USPHS criteria)
time frame: 24 months
Marginal Discoloration, graded on a 3-point scale (USPHS criteria)
time frame: 24 months
Color Match, graded on a 3-point scale (USPHS criteria)
time frame: 24 months
Retention, graded on a 3-point scale (USPHS criteria)
time frame: 24 months
Marginal Integrity, graded on a 4-point scale (USPHS criteria)
time frame: 24 months
Postoperative Sensitivity, graded on a 2-point scale (USPHS criteria)
time frame: 24 months
Secondary Caries, graded on a 2-point scale (USPHS criteria)
time frame: 24 months
Gingival Bleeding, graded on a 2-point scale (USPHS criteria)
time frame: 24 months

Eligibility Criteria

Male or female participants from 18 years up to 65 years old.

Inclusion Criteria: - Patients of both genders - ages up to 18 years old and less than 65 years old - Patients with diagnosis and treatment required of dental structure loss in cervical vestibular surfaces with non-bacterial or chemical origin, which is non-carious cervical lesions (NCCL) in premolar/molar teeth (These lesions have to be non-carious, non-retentive, deeper than 1 mm, and involve both the enamel and dentin of vital teeth without mobility. The cavo-surface margin cannot involve more that 50% of enamel.) Exclusion Criteria: - Patients with a number of teeth inferior than 20 in occlusion; - If the tooth is not vital; - Chronic periodontal disease; - Incapacity to return to follow-up; - To participate in another clinical evaluation in course at that time; - Medical, psychiatric history or pharmacotherapy to compromise the protocol - Pregnancy; - Allergies and idiosyncratic answers to the ingredients of the products; - Fixed orthodontic treatment; - Teeth support for fixed prosthodontic treatments; - Teeth or structures of support with pulpa injury in transition phase; - Periodontal surgery in the 3 previous months; - Severe bruxism; - Extremely poor oral hygiene; - Patient refuse to voluntary participate in the trial.

Additional Information

Official title NCCL Direct Composite Restoration Performance With Self-Etch and Multimode Adhesives Clinical Trial
Principal investigator Patrícia Manarte-Monteiro, PhD
Description 2.1- DESIGN The trial design will follow the Consolidated Standards of Reporting Trials (CONSORT) statement (1, 2). Prospective, double blind, clinical trial; randomized allocation of NCCL restorations by six adhesion treatment groups (6 arms: G1 to G6) for examination of restorations performance. Study will take place in University Fernando Pessoa - Faculty of Health Sciences (UFP-FHS), Dental Medicine School Clinic. Patients recruitment between November 2015 and April 2016. Restorations estimated to be done until April 2016. Period of Study The study is scheduled to last 24th months. Baseline clinical observation will be done 30 days after placement of adhesion restoration (First data), second evaluation 12th months after baseline (Second data), and last evaluation 24th months after baseline data (Third data). Clinical trial may continue for similar assessment intervals, after 24th months evaluation. This situation requires new analysis according to clinical and economics conditions, at that time. 2.2- POPULATION AND PARTICIPANT SELECTION All participants will be informed (Written and verbal information) about the trial conditions and purposes, but will not be aware of what tooth will received the adhesion treatment strategy under evaluation. Written informed consent, according to World Medical Association Declaration of Helsinki (3), will be obtained from all participants prior to starting the treatment. University Fernando Pessoa Ethics Committee review and approved the present protocol. This clinical trial is done according to the National Law 21/2014, of 16 April, and was analysed, approved and authorized by the National Competent Authorities: - INFARMED, National Authority of Medicines and Health Products, IP (No.EC/011/2015; DPS/DM/450.10.053/2015/0314; Authorization at 4th August 2015) - CEIC, National Ethics Committee for Clinical Research (No.20150305; Approved at 3th August 2015) - CNPD, Portuguese Data Protection Authority (Authorization and registry 6430/2015 at 7 July 2015; No.2536/2015). The decision to participate in this study is voluntary as well as the decision to refuse participation and decision of withdrawal of the same, at any time of the study course, are rights of the patient/participant. Given the purpose of this study, and the fact of existing multiple and several market therapeutic alternative for this type of interventions, the fact that participate in this study will not entail any additional cost, the one described in the fee schedule of Dental Medicine School Clinic-UFP. They will not be granted any incentives or financial benefits (payment of travel or counter-parties) to participate in the trial. The participant has as cost the "restoration of the tooth surface, which of course would have to make even not participating in this investigation. The clinical observations, temporarily established (3 appointments in two years), to evaluate the performance of the restorations will be free for the participants. All other acts that the patient needs or intends to perform, not included in the protocol of this trial, should meet the same, the fee scale of Dental Medicine School Clinic-UFP. Dental restorations are applied to tooth surfaces requiring intervention/repair for the maintenance of dental structure in oral cavity of the patient. The operator (Dentist and Associate Professor of FHS-UFP) inform the patient/participant in all aspects related to the study. Refusal of patient participation, the participant's withdrawal and revocation of consent to participate in this study are rights of the patient/participant without any consequences or reprisal, and without interference in the relationship between users and teachers/ researchers / University, clinical entities. SAMPLE: Patients with clinical diagnosis of tooth structure coronal loss and needs for cervical (vestibular surface) restoration without chemical or bacterial origin, called non-carious cervical lesion (NCCL) located in pre- molars/molars (PM/M) teeth, with cavity dimensions defined in the study design; a patient can have up to 16 teeth (8PM + 8M) with NCCL. Two hundred and ten restorations will be performed, randomized in order to be allocated to six interventions, named as adhesion intervention groups. Within this trial, the number of teeth to be restored by participant will be between a minimum of 1 and a maximum of 6. The allocation of the study group (G1 to G6) to a particular tooth is random with the information available to the operator/principal investigator in sealed envelopes and previously prepared by the investigator-professional statistics. The allocation of the study group (G1, G2, G3, G4, G5, G6) to each tooth for a patient is performed randomly, but ensuring that the distribution of the groups is not repeated in the same patient. For this purpose, 210 envelopes with 35 sequences of 6 study groups will be organized by the statistical investigator (wherein each order of 6 groups is randomized). If the patient has more than six teeth that meet the inclusion criteria, the selection of the premolars and molars to be included in the clinical trial will be conducted randomly by scenarios randomized by the investigator of the statistical area after participation and contact for the effect (not done a priori, since it is necessary 19448 scenarios prior randomization before observing any patient, whereas the possible teeth be selected for treatment is between 6 and 16 and the teeth to select from 6). The participant has as cost the academic/scientific honorary, as in usual clinical context of Dental School Clinic of Faculty of Health Sciences - UFP as "restoration of a tooth surface"/ by tooth to restore (One to six teeth), which of course would have to make even not participating in the investigation, as the Dental School Clinic fee scale. The restorations included in this trial will be evaluated for clinical performance, for three time periods (Baseline, 1 year and 2 years), by the three calibrated examiners. These 3 observation appointments, as part of the clinical trial, will be free for participants. 2.3- STUDY ADHESION ARMS Six groups (G1, G2, G3, G4, G5, G6) of NCCL restorations will be randomized allocated according to adhesion strategy intervention. 2.4- OPERATOR / EXAMINERS CALIBRATION Operator will do one restoration of each group in order to identify all steps involved in the application technique. This procedure will be done three times, with one week, interval. All restorations done by the same calibrated operator. Three experienced and calibrated dentists, not involved with the restoring procedures and therefore blinded to the group assignment, will perform the clinical evaluation. For training purposes, the examiners observed 10 photographs that were representative of each score for each criterion, in 10 cervical restorations (not included in this trial), each one, on two consecutive days. An intra-examiner and inter-examiner agreement will be calculated. Medical Devices Composition (According to Manufactures, Voco and Ivoclar Vivadent Safety data sheets for Adhesives and products): 1. Futurabond® DC (Voco, Cuxhaven, Germany) Batch No.1532592: Liquid 1. Acidic adhesive monomer; BIS-GMA (5-10%), 2-HEMA (5-10%); pH-value 1.5 Liquid 2. Ethanol (50-100%); Initiator (2.5-5%) Mixture. organic acids, BIS-GMA, 2-HEMA, TMPTMA, campherchinon, amines (DABE), BHT, catalysts, fluorides and ethanol. 2. Futurabond® U (Voco, Cuxhaven, Germany) Batch No.1543141: Liquid 1. 2-hidroxyethyl methacrylate (2-HEMA) (25-50%); BIS-GMA (25-50%); HEDMA (10-25%); Acidic adhesive monomer (5-10%); Urethanedimethacrylate (UDMA) (5-10%); catalysts (≤ 2.5%); pH-value 2.3 Liquid 2. Ethanol (50-100%); Initiator (2.5-5%); catalysts (≤ 2.5%) 3. Ivoclar Vivadent's Adhese® Universal (Ivoclar Vivadent AG, Liechtenstein) Batch No.U35131: Composition/information on ingredients; mixture of substances Liquid: 2-hydroxyethyl methacrylate (20-<25%); bisphenol A diglycidyl ether dimethacrylate (20-<25%); ethanol (10-<25%); decamethylene dimethacrylate (3-<10%); Methacrylated phosphoric acid ester (3-<10%); campherquinone (1-<2.5%); 2-dimethylaminoethyl methacrylate (1-<2.5%); 2,6-di-tert-butyl-p-cresol (0.1-<0.3%). (MDP-Methacryloyloxydecyl dihydrogen phosphate; MCAP- Methecrylated carboxylic acid polymer; HEMA-Hydroxyethil methacrylate; Bis-GMA_ Bisphenol A glycidyl methacrylate; D3MA- Decandiol dimethacrylate); pH-value 2.5-3.0. 4. Vococid® (Voco, Cuxhaven, Germany) Batch No.152135: 35% orthophosphoric acid; 2.5- DATA REGISTRY/PROTECTION AND RESTORATIONS PROCEDURES Photographs (digital data registration) will be carried out by the operator/responsible for research, strictly made to NCCL cavities and restorations as part of this trial. No photographs will be made to identify the patient, including photographs of the patient face or profile. All photographs taken in the context of this study will be "identified" (file name) with a single key (alphanumeric key without any kind of relationship with file number, name, date of birth or other information associated with the participant patient). Only in the registration database (with access to the principal investigator and other team members, with the exception of the statistical investigator for the purposes of observational clinical records) there should be registration/membership of this key with the code-process of patients. The database in question will be lodged in own servers with restricted access levels and well identified. The servers that lodge the photos/ records and the database belong to Dental School Clinic of Faculty of Health Sciences - UFP and are located in data centre with fully controlled access. This mechanism ensures the concealment of identity of the user (as name and other information identifying the participant) in the photographs and other records file, having access to them only the investigator and research team (except investigator of statistics). This mechanism fulfilled the recommendation and Authorisation of CNPD, Portuguese Data Protection Authority (Authorization and registry 6430/2015 at 7 July 2015; Case 2536/2015). Appointment and restorative procedures, in accordance with the following steps: One week, before the Restorative procedure (1st appointment): Inform the patient (Written/Verbal); Patient signature of informed consent; Fulfilment of the project clinical file (patient identification, general clinical summary, oral clinic examination, oral hygiene state); Dental prophylaxis with fluoride toothpaste and water with a nylon brush. Vitality tests (cold and hot) executed with spray Endo cool (ethyl chloride) and warm instrument; Pre-operative sensitivity evaluation by applying air for 10 seconds from a dental syringe placed 2 cm from the tooth surface (4); NCCLs cavities will be evaluated according to the degree (1, 2, 3, 4) of sclerotic dentin (5), cavity dimensions (H-height, W-width, and D-depth) in millimetres (mm) and geometry (evaluated by profile photograph, as Angles Acute (A), Severe (S), Obtuse (O) (4); 1st Appointment-Intervention: Initial intra-oral/cavity surface and tooth digital photography; Teeth anaesthesia with 3% mepivacaine (Scandinibsa, Sintra Business Park, Portugal); Operatory field isolation with cotton rolls and retraction floss (Ultradent). All cavities cleaned with pumice and water in a rubber cup, followed by rinsing and drying. Selection composite colour by shade guide; Adhesive interventions according to G1 to G6 arms assignment. Adhesive systems will be used as SingleDose mode. Composite restorations (AdmiraFusion Universal nano-hybrid composite) with incremental filling technique (two increments maximum), light-cured (LED Unit) with an intensity of 1000mW/cm2, during 40 seconds. Restorations will be finished immediately with diamond disks (OptiDisc® medium 40μm; Kerr) and burns. Polishing performed with diamond-impregnated silicone polishers (Dimanto, Voco, CuxHaven) during 10 seconds. Intra-oral digital photography of the restoration. 2.6- CLINICAL FOLLOW-UP Baseline (30 days after restoration), 12th and 24th months Appointments 1 - Intra-oral digital photography of the NCCL restoration; 2- Post-operative sensitivity evaluation by applying air for 10 seconds from a dental syringe placed 2 cm from the tooth surface (4); 3 - Direct evaluation by 3 calibrated examiners according to FDI (6, 7) and USPHS (8); 4- Data register Study variable definition - Clinical/direct observation and performance evaluation acceptance by means of FDI (FDI World Dental Federation - clinical criteria for the evaluation of direct restorations) (6, 7) and USPHS (8). 2.7- DATA BASE AND STATISTICAL ANALISYS Data statistical analysis and description according to aims of this trial; Specific program for statistical data analysis (IBM(c) SPSS(c) Statistics vs. 23 or later) will be used. The changes in parameters will be assessed Qui2 and Fisher exact tests for the cross sectional assessment of the six groups treatment groups at baseline, one year and two years. For a paired comparison analysis and to determine differences between treatments with regard to aesthetic, functional and biological parameters between baseline and the two-year follow-up (longitudinal assessment), the McNemar test will be used. To quantify the relative influence of patients' covariates (ie, smoking habits, oral hygiene) on clinical performance of the restorations, Kaplan Meier curves and Cox regression will be used. Differences will be considered to be significant at P<0.05. 2.8- OBSERVATIONS REGARDING SAMPLE CALCULATION Was assumed that the minimum number of bonded restorations to be held in each of the six arms (G1 to G6) is 35 (210 restorations). The researchers did not have detailed information that allows the estimation of the sample size based on power analysis (the effect of the expected difference to the end of the time considered for the study). Thus, using rules of thumb usually considered in research situations where there is no prior information concerning the performance evaluation of these class IIa medical devices available on the market. In this case, considering that it intends to make a prospective longitudinal study, in which the result "failure" can be data processing target through Kaplan Meier curves and Cox regression to determine factors associated with failure rate and reduced clinical performance criteria of the restorations (evaluation of clinical performance over time, of the medical devices under study), and to detect effects depends the number of events (failure, for example, or other event that is to be considered in the defined evaluation criteria) and not the number of patients/participants, the thumb rules stipulate a minimum of 10 cases by group. Moreover, when considering an "simple" analysis comparison using a McNemar test (repeated measures) in six groups would be necessary in total, including at least 80 cases (to restore teeth) in the sample. When considering at least 35 restorations by group, researchers are greatly increasing the minimum number stipulated in any of the aforementioned techniques. In addition, clinical studies previously performed on this issue (between 2004 and 2012) relative to the post-market clinical evaluation performance of class IIa medical devices, in the context of restorative dentistry field, has enabled to measure a minimum of 30 restorations as viable for determining events in a short/medium-term as the clinical performance evaluation of a similar nature of medical devices. 2.9- GOOD CLINICAL PRACTICE FOR CLINICAL RESEARCH Reporting mechanism of possible adverse incident during the investigation will be held according to Medical Devices (MD) commercially available in the market, so it interprets and assumes the issue as applicable to assumptions in the Portuguese National Law (Article 22) 21/2014, of 16 April, calling up a mechanism for reporting any incidents inherent to medical devices or resulting from the use of medical devices. In this way, and considering the type of intervention to carry out in this research (restoration of very small extension of NCCL with dental adhesives), the medical devices (Adhesive systems) are not described in the literature and not known records for the occurrence of undesirable incidents, with interpretative effects as Serious or Unexpected "adverse incidents". However, and according to good clinical practice for clinical research, the reporting mechanism of Serious or Unexpected incidents (protocol version FHS-UFP-FFP-2014 April-19.07.2015) for this research are approved by CEIC (National Ethics Committee for Clinical Research (No.20150305; Approved at 3th August 2015), as followed: 1. Clinical knowledge of the incident taken by the principal investigator; 2. Register of occurrence and possible reasons associated with it; 3. Clear Information to the participant about the serious or unexpected adverse occurrence, providing urgent measures as may be appropriate to safety protect the subjects against any immediate risk or any fact relating to the conduct of the trial. 4. The investigator notifies the clinical Director and the Sponsor within 24 hours of all serious or unexpected events, and the defects of devices that could have led to a serious adverse event, except those conditions that are identified in the protocol (loss of retention of the adhesive restoration) or in the investigator's brochure as not requiring immediate reporting; 5. Investigator presents to the sponsor a detailed written report, within five days. 6. The Sponsor ensure that: 1. All important data regarding serious adverse events related to the clinical trial, which has caused or may cause death or severe deterioration of the health status of participants, users or third parties involved in the study, they are recorded and notified to the National Authorities INFARMED (National Authority of Medicines and Health Products, IP) and CEIC (National Ethics Committee for Clinical Research), immediately and not more than two days from the moment in which aware of them; 2. - Another type of adverse events, in particular regarding defects of medical devices that could have led to a serious adverse event and new data on any adverse event is recorded and notified National Authorities, INFARMED (National Authority of Medicines and Health Products, IP) and CEIC (National Ethics Committee for Clinical Research), within a period of seven days, starting from the moment they become aware of them. All supervening information considered relevant by the competent authorities will be notified within eight days from the closing date provided for in the preceding paragraph. 7. The investigator sends to the sponsor, the CEIC and INFARMED any additional information that may be requested. 8. Sponsor keeps detailed records of all adverse events, which are reported to him, by any investigator. 9. Other suspected serious and unexpected adverse events are reported by the sponsor to the CEIC, INFARMED and CNPD within 15 days from its notice by the promoter. Sponsor reports annually to CEIC and INFARMED a list of all suspected serious adverse events, during this period as well as a report on the safety of participants, if applicable. Under the study protocol (Version FCS-UFP-FFP-2014 April-19.07.2015), all the possible non-serious adverse events such as, clinical signs or symptoms associated with loss of aesthetic, functional and biological performance of restorations and situations described in the instructions, labelling and safety data sheets of medical devices or even, without incident and security maintenance data of the participants the sponsor notifies the CEIC and INFARMED, only by the final evaluation of this study (two years of clinical performance), as set forth in article 24th of Law 21/2014 of 16 April, which will include a report of suspicious occurrences and safety records and, if applicable, in the clinical trial in the period Evaluation of two years. Or annually, if the CEIC advise, even in the absence of adverse events or information, justifying changes to the safety of participants.
Trial information was received from ClinicalTrials.gov and was last updated in May 2016.
Information provided to ClinicalTrials.gov by University Fernando Pessoa.