Survival Rate and Cost-effectiveness of Conventional vs ART Restorations in a School Setting

NCT05766696 | Active Not Recruiting

• 1 other identifier: DeltaART
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

This study will investigate the performance and cost-effectiveness of glass-ionomer restorations placed in school children in an outreach setting in rural areas in South Africa over a 2-year period, when placed using either ART (in a classroom) or conventional (in a mobile clinic) cavity preparation.

Conditions

Dental Caries

Keywords

Glass Ionomer Cements; Atraumatic Restorative Treatment; Cost Effectiveness; Oral Health

Outcome Measures

Primary Outcomes (1)

• Survival rate of posterior occlusal multi-surface restorations

  Restorations are assessed using the ART criteria by Frencken: Survival: Code 0 (Present, satisfactory); Code 1 (Present, slight deficiency at cavity margin of less than 0.5 mm) Failure: Code 2 (Present, deficiency at cavity margin of 0.5 mm or more); Code 3 (Present, fracture in restoration); Code 4 (Present, fracture in tooth); Code 5 (Present, overextension of approximal margin of 0.5 mm or more); Code 6 (Not present, most or all of restoration missing); Code 7 (Not present, other restorative treatment performed); Code C (Dentin carious lesion present)

  24 months

Secondary Outcomes (2)

• Survival rate of restorations depending on lesion type (occlusal single surface, occlusal multi surface and approximal restorations)

  6, 12 and 24 months

• Incremental cost-effectiveness ratio (ICER)

  6, 12 and 24 months

Other Outcomes (2)

• Lesion size

  Intervention at baseline

• Treatment time (continuous outcome, minutes)

  Intervention at baseline

Study Arms (2)

Atraumatic Restorative Treatment (ART)

EXPERIMENTAL

GIC restorations placed using ART in a class room.

Procedure: Atraumatic Restorative Treatment (ART)

Conventional Cavity Preparation

ACTIVE COMPARATOR

GIC restorations placed using conventional cavity preparation in a mobile clinic.

Procedure: Conventional Cavity Preparation

Interventions

Atraumatic Restorative Treatment (ART) PROCEDURE

Conventional glass-ionomer restorations are placed using the Atraumatic Restorative Treatment (ART) technique. Essentially, cavities are prepared using hand instrument excavators. Afterwards, the cavity is conditioned (using a 10% polyacrylic acid conditioner) and cleaned, with subsequent insertion of a conventional restorative glass-ionomer. During the curing phase, Vaseline will be applied to all restoration surfaces for moisture protection. The treatment will be conducted in a class room. As concomitant treatment, all participants will receive supervised toothbrushing during the study using 1,450 ppm fluoride toothpaste once a day.

Atraumatic Restorative Treatment (ART)

Conventional Cavity Preparation PROCEDURE

Conventional glass-ionomer restorations are placed after conventional cavity preparation. Essentially, cavities are prepared using rotary instruments/diamond burs. Afterwards, the cavity is conditioned (using a 10% polyacrylic acid conditioner) and cleaned, with subsequent insertion of a conventional restorative glass-ionomer. During the curing phase, Vaseline will be applied to all restoration surfaces for moisture protection. The treatment will be conducted in a mobile clinic. As concomitant treatment, all participants will receive supervised toothbrushing during the study using 1,450 ppm fluoride toothpaste once a day.

Conventional Cavity Preparation

Eligibility Criteria

• Age: 4 Years - 8 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Children (4-8 years of age)
• Guardians have given informed consent
• Child is cooperative and assented
• Cavity \> 1 mm
• Tooth has no pathological mobility
• Tooth has no preexisting developmental defects
• Tooth has no pulp exposure or is indication for endodontic treatment
• No pain, fistula or abscess related to the selected tooth

You may not qualify if:

• Cavity \> 1 mm
• Tooth has no pathological mobility

Sponsors & Collaborators

• DMG Dental Material Gesellschaft mbH: lead

Study Sites (1)

Nyameko and Itsitsa Primary Schools

Mfuleni, Western Cape, 7100, South Africa

Location

MeSH Terms

Conditions

Dental Caries

Interventions

Dental Atraumatic Restorative Treatment

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Dentistry

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This study is a parallel-group, randomized, controlled non-inferiority trial with a 2-year follow up. School children (from 2 schools) in a township in South Africa are randomized to the ART group (class room) or Conventional group (mobile clinic).

Study Record Dates

• First Submitted: March 2, 2023
• First Posted: March 13, 2023
• Study Start: February 24, 2025
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): February 1, 2027
• Last Updated: April 13, 2026

Record last verified: 2026-04

Locations

ZA (1)