CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 169 enrolled
Drug / intervention
Hall Technique +2 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/NCT01797458
NCT01797458N/ACompleted

Randomised Control Trial on Three Different Approaches to Managing Class 2 Cavities in Primary Teeth

University Medicine Greifswald·interventional·Posted Feb 22, 2013·Updated Sep 7, 2022

In Brief

A clinical study evaluating Hall Technique, Non-Restorative Caries Treatment, and 1 other intervention for Dental Caries. Completed, enrolled 169 participants across 3 sites in 3 countries.

Detailed Summary

The purpose of this randomized clinical trial is to compare the clinical effectiveness of three treatments involving different caries management strategies (conventional restorations, Hall technique, and Non-Restorative Caries Treatment) to the management of class II carious primary molars in children (3-8 year-old).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDental Caries
CountriesGermany, Lithuania, United Kingdom

Timeline

N/ACompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedFeb 22, 2013
Enrollment StartMay 1, 2011
Primary CompletionDec 1, 2013
Study CompletionDec 1, 2014
TodayJul 2, 2026
Enrollment to primary: 2.6 yearsPosted 13.4 years ago

Interventions

Hall Techniqueprocedure

Technique: * Removal of dental plaque and rest of aliments from the cavity * Selection of the SSC * If the contact points are very tight, orthodontic separator elastics could be placed through the mesial and distal contacts and the SSC has to be fitted at a subsequent appointment * Dry the crown and fill with glass-ionomer luting cement * Place the crown over the tooth * Removal of cement excesses from the crown margins * The child should be asked to keep biting on the crown until the cement has set

Non-Restorative Caries Treatmentprocedure

Technique: * A high-speed bur should be used to remove the undermined enamel and make the cavity accessible for plaque removal. Do not remove the contact area * Clean, dry the cavity and apply Duraphat® varnish fluoride (50/mg/ml) * Show the cavity to patient/parents and give them tooth-brushing instructions * Tell to parents that good plaque control is the key for this treatment * The recall interval for these patients is every 3 months.

Conventional Restorationprocedure

Technique: * Local anesthesia should be used when needed * Perform complete caries removal and cavity preparation * Use a matrix band and a wedge to tightly hold the band against the tooth * Place the material (Compomer) * Check contacts and occlusion, and polish the restoration