Overview

This trial is active, not recruiting.

Condition deep caries
Treatment indirect pulp capping
Phase phase 2/phase 3
Sponsor Cairo University
Start date August 2015
End date November 2016
Trial size 36 participants
Trial identifier NCT02930135, 1-10-2014

Summary

The aim of this study is to compare the clinical and radiographic success of indirect pulp capping of vital young permanent teeth with deep caries using two-step antibacterial bonding system versus conventional one.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
Indirect pulp capping using antibacterial bond and x-tra fil composite Local anesthesia administration Isolation of tooth with rubber dam Opening of the cavity and the removal of undermined enamel Caries at the lateral walls of the cavity and at the dentin-enamel junction is completely removed Partial removal of carious dentin on the pulp wall. Washing the cavity and dryness Apply antibacterial light-cure, self-etching bonding agent (Clearfil SE Protect, Kuraray America, Inc.) Light-cured bulk fill composite (x-tra fil, VOCO) used as final tooth restoration.
indirect pulp capping Partial caries removal
Removal of superficial caries in young permanent molars that my expose tooth pulp if totally removed leaving deep carious layers to be sealed inside with two step bonding system and bulk fill composite as a final restoration
(Active Comparator)
Indirect pulp capping using conventional bond and x-tra fil composite Local anesthesia administration Isolation of tooth with rubber dam Opening of the cavity and the removal of undermined enamel Caries at the lateral walls of the cavity and at the dentin-enamel junction is completely removed Partial removal of carious dentin on the pulp wall. Washing the cavity and dryness Apply conventional light-cure, self-etching bonding agent (Clearfil SE Bond, Kuraray America, Inc.) Light-cured bulk fill composite (x-tra fil, VOCO) used as final tooth restoration.
indirect pulp capping Partial caries removal
Removal of superficial caries in young permanent molars that my expose tooth pulp if totally removed leaving deep carious layers to be sealed inside with two step bonding system and bulk fill composite as a final restoration

Primary Outcomes

Measure
change/evidence of post treatment spontaneous and provoked pain by questioning the patients
time frame: Immediate post operative, 2, 6, 9 month

Secondary Outcomes

Measure
Absence of pain on percussion
time frame: Immediate post operative, 2, 6, 9 month
Absence of post treatment swelling
time frame: Immediate post operative, 2, 6, 9 month
Absence of adverse radiographic findings
time frame: Immediate post operative, 2, 6, 9 month

Eligibility Criteria

Male or female participants from 6 years up to 14 years old.

Inclusion Criteria: 1. Patients free from any systemic diseases. 2. Young permanent molars with deep carious lesions according to clinical and radiographic examination and at risk of pulp exposure if complete caries is removed. 3. Absence of clinical pathologic signs (fistula, swelling and abnormal tooth mobility) 4. The absence of clinical symptoms of irreversible pulpitis such as spontaneous pain or pain persisting after the disappearance of the existing stimulus or sensitivity to pressure. 5. Absence of adverse radiographic findings (interradicular or periapical radiolucencies, thickening of the periodontal membrane space, internal and external root resorption). 6. Compliant patient/parent. Exclusion Criteria: 1. Teeth with previous restorative treatment. 2. Unrestorable teeth. 3. Uncooperative patients.

Additional Information

Official title Evaluation of Post Operative Pain Following Indirect Pulp Treatment in Young Permanent Teeth Using Antibacterial Versus Conventional Two-Step Bonding System: A Randomized Clinical Trial
Description The study was carried out on patients attending outpatient clinic in Pediatric and Dental Public Health department- Faculty of Oral and Dental Medicine Cairo University- Egypt. **Sample size: On searching, no previous studies were conducted using neither conventional bonding nor antibacterial bonding in indirect pulp treatment in young permanent teeth, so sample size will be measured by estimation rather than calculation. So, all patients attended outpatient clinic in Pediatric and Dental Public Health department- Faculty of Oral and Dental Medicine Cairo University- Egypt, In the period from 1/8/2015 - 31/10/2015 were enrolled for this study if they compatible with eligibility criteria. **Clinical Procedures: I. Diagnosis: Full personal, medical and dental history,clinical and radiographic examination. II. Allocation concealment: Selected envelopes will be opened in the first visit to allocate the patients to their treatment groups . III.Intervention: A- Experimental Group: Indirect pulp capping with Antibacterial Two-Step Bonding System: 1. Local anesthesia. 2. Isolation of tooth with rubber dam. 3. Opening of the cavity and the removal of undermined enamel using high speed hand-piece with copious air/water spray and round burs. 4. Caries at the lateral walls of the cavity and at the dentin-enamel junction is completely removed with excavators or low speed round burs. 5. Partial removal of carious dentin (only soft disorganized dentin is removed) on the pulp wall. 6. Washing the cavity with distilled water and dryness with triple airway syringe and sterile cotton. 7. Apply antibacterial light-cure, self-etching bonding agent (Clearfil SE Protect, Kuraray America, Inc.) 8. Light-cured bulk fill composite (x-tra fil, VOCO) will be used as final tooth restoration. 9. Postoperative digital radiograph will be taken as a base line. B- Comparative Group: Indirect pulp capping with Conventional Two-Step Bonding System Same as that of the experimental group EXCEPT steps number 5 as conventional light-cure, self-etching bonding agent (Clearfil SE Bond, Kuraray America, Inc.) will be applied into cavity according to manufacturer's instruction. IV. Follow up and postoperative instructions: - Patients will be recalled 48 hours after the treatment then at 2, 6, 9 months
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by Cairo University.