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ART and Hall Technique for Management of Occlusal-proximal Caries in Primary Molars

NCT02569047 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 131

Last updated 2019-08-29

No results posted yet for this study

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.

Conditions

  • Dental Caries

Interventions

PROCEDURE

Atraumatic Restorative Treatment

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.

PROCEDURE

Hall Technique

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.

Sponsors & Collaborators

  • University of Dundee

    collaborator OTHER

  • Academic Centre for Dentistry in Amsterdam

    collaborator OTHER

  • University of Sao Paulo

    lead OTHER

Principal Investigators

  • Daniela P Raggio, Professor · University of Sao Paulo

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
5 Years
Max Age
10 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-10-31
Primary Completion
2018-11-30
Completion
2018-11-30

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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 NCT02569047 on ClinicalTrials.gov