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European Study on Three Different Approaches to Managing Class 2 Cavities in Primary Teeth

NCT01797458 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 169

Last updated 2022-09-07

Study results available
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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).

Conditions

  • Dental Caries

Interventions

PROCEDURE

Hall Technique

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

PROCEDURE

Non-Restorative Caries Treatment

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.

PROCEDURE

Conventional Restoration

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

Sponsors & Collaborators

  • University of Dundee

    collaborator OTHER

  • Lithuanian University of Health Sciences

    collaborator OTHER

  • University Medicine Greifswald

    lead OTHER

Principal Investigators

  • Christian H Splieth, Prof. Dr. · University Medicine Greifswald

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
3 Years
Max Age
8 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-05-31
Primary Completion
2013-12-31
Completion
2014-12-31

Countries

  • Germany
  • Lithuania
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01797458 on ClinicalTrials.gov