CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 131 enrolled
Drug / intervention
Atraumatic Restorative Treatment +1 moreprocedure
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02569047
NCT02569047N/ACompleted

ART and Hall Technique for the Management of Occlusal-proximal Caries in Primary Molars: A Randomized Clinical Trial

University of Sao Paulo·interventional·Posted Oct 6, 2015·Updated Aug 29, 2019

In Brief

A clinical study evaluating Atraumatic Restorative Treatment and Hall Technique for Dental Caries. Completed, enrolled 131 participants.

Detailed 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 (5-10 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDental Caries
Countries--

Timeline

N/ACompletedFinished
20162017201820192020202120222023202420252026
First PostedOct 6, 2015
Enrollment StartOct 1, 2015
Primary CompletionNov 1, 2018
TodayJul 2, 2026
Enrollment to primary: 3.1 yearsPosted 10.7 years ago

Interventions

Atraumatic Restorative Treatmentprocedure

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.

Hall Techniqueprocedure

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.