Overview

This trial is active, not recruiting.

Condition dental caries
Treatments atraumatic restorative treatment, hall technique
Sponsor University of Sao Paulo
Collaborator University of Dundee
Start date October 2015
End date June 2016
Trial size 120 participants
Trial identifier NCT02569047, HALLART

Summary

The aim of this, two-arm, parallel group, patient-randomised controlled, superiority trial is to evaluate the survival rate of approximal Atraumatic Restorative Treatment (ART) restorations compared to the Hall Technique (HT) placed in a school setting. The investigators will recruit 120 schoolchildren (6-8 years) with at least one occlusal-proximal carious lesion in primary molar. They will be randomized and treated following best-practice protocols to either receive an ART restoration using the high-viscosity glass ionomer cement (EQUIA Forte, capsules, GC Corp.) or a preformed metal crown placed using the HT (3M ESPE) cemented with glass ionomer luting cement (Fuji I Capsules, GC Corp.). Baseline measures and outcome data (at reviews over a three year period) will be assessed through participant report, clinical examination and parent report/ questionnaires.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Active Comparator)
The cavity will be prepared according to the ART (Atraumatic Restorative Treatments) steps and filled with the dental material Glass Ionomer Cement without local anesthesia.
atraumatic restorative treatment Equia Forte
No local anaesthesia will be used. Infected carious tissue will be removed with hand instruments, and the cavities restored with Glass Ionomer Cement (GIC).The cavity will be filled with GIC. After the press-finger technique, the excess of material will be removed.
(Experimental)
The cavity will not receive any preparation. A stainless crown will be placed and cemented with the dental material Glass Ionomer Cement without local anesthesia.
hall technique Metal Crowns
It employs the cementation of preformed metal crowns (PMC) without the need of any prior teeth preparation or caries removal. No local anesthesia is used neither tooth preparation.Different sizes of PMCs will be tested until the smallest size that perfectly fit the tooth is achieved. The PMC will be loaded with the dental material glass ionomer cement (GIC) and placed. Child will asked to bite firmly on it, until it is fitted. The excess of GIC will be removed with hand instruments and dental floss.

Primary Outcomes

Measure
The restoration survival (changes from baseline up to 36 months)
time frame: The treatments will be evaluated after 1 week up to 36 months

Secondary Outcomes

Measure
Child self-reported discomfort
time frame: Baseline
Perception and concerns related to tooth appearance.
time frame: up to 6 months
Acceptance of children in relation to treatments performed.
time frame: Immediately after treatment (in the same appointment)
Acceptance of parents in relation to treatments performed.
time frame: Immediately after treatment (in the same appointment)
Occlusal vertical dimension assessment
time frame: The measurements will be done before treatment, immediately after treatment (in the same appointment) and at each check-up appointment (1 week and 1, 6, 12, 24 e 36 months)
Cost-effectiveness assessment
time frame: Up 36 months
Oral Health Quality of life (OHRQoL) assessment
time frame: Before the treatment and during the 1 month recall

Eligibility Criteria

Male or female participants from 6 years up to 8 years old.

Inclusion Criteria: - children aged between 6 and 8 years - cooperative behavior - presenting good health conditions - whose parents or legal guardians accept and sign the consent form - with at least one occluso-proximal lesion in primary molar - only occlusal-proximal surfaces with caries lesions with dentin involvement - cavities accessible to hand instruments used in ART - absence of fistula or abscess near the selected tooth - absence of pulp exposure in the selected tooth - absence of mobility in the selected tooth - cavity size in the selected tooth not be bigger than 2.0 mm in the mesial-distal and 2.5 in the occlusal-cervical and bucco-lingual directions. Exclusion Criteria: - children younger than 6 years and older than 8 - non-cooperative behavior - without good health conditions - whose parents or legal guardians did not accepted and signed the consent form - without any occluso-proximal lesion in primary molar - caries in the selected tooth reaching other surfaces (than occlusal-proximal surface) - occlusal-proximal surface with caries without dentin involvement - cavities not accessible to hand instruments - fistula or abscess near the selected tooth - pulp exposure in the selected tooth - mobility in the selected tooth - cavity size bigger than 2.0 mm in the mesial-distal and 2.5 in the occlusal-cervical and - bucco-lingual directions.

Additional Information

Official title ART and Hall Technique for the Management of Occlusal-proximal Caries in Primary Molars: A Randomized Clinical Trial
Principal investigator Daniela P Raggio, Professor
Description The selected children will be randomly allocated into 2 groups. The control group will comprise cavities treated by ART, following the protocol proposed by Frencken and Holmgren (1999), while the experimental group will comprise cavities treated by HT, according to the guideline published by Innes and Evans (2011). The allocation of patients in each group will be carried out by a random list generated by a specific computer program. To ensure the allocation concealment, the sequence generated by randomization will be distributed in opaque, sealed envelopes, which will be opened by the operator during the treatment, only after the patient is ready to receive treatment. Operators will be two undergraduate students in dentistry and one experienced specialist in pediatric dentistry that will be trained on how to prepare and fill the cavities according to the original procedures of ART (Frencken and Holmgren, 1999) and also according to HT (Innes and Evans, 2011). The training will include a lecture about the techniques used in this study, as well as a workshop held in the laboratory for students to train handling and application of treatments to be tested. They will also undergo a week of training with patients, to apply the different techniques before starting the study, the latter phase held at the Faculty of Dentistry, University of São Paulo, under the supervision of an experienced dentist in ART and HT. Each child will be allocated for one of the operators with the aid of a random list. All treatments will be performed on the school premises, in field conditions without the use of dental chair or other facilities from a clinical environment.
Trial information was received from ClinicalTrials.gov and was last updated in June 2016.
Information provided to ClinicalTrials.gov by University of Sao Paulo.