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

Dental Material Gesellschaft

Status: Not yet enrolling

Conditions: Dental Caries

Treatments: Procedure: Conventional Cavity Preparation; Procedure: Atraumatic Restorative Treatment (ART)

Study type: Interventional

Funder types: Industry

Identifiers

NCT05766696

DeltaART

Details and patient eligibility

About

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.

Full description

Access to dental care in South African townships is very limited, as indicated by a caries prevalence of 84% and severity of 4.9 (dmft) in 6 year olds. To tackle this burden school-based tooth-brushing programs have been suggested to be cost-effective while reducing inequalities in accessibility. However, despite their efforts, the caries burden remains high.

Alternatives are mobile dental services or treatment techniques that do not require extensive equipment such as Atraumatic Restorative Treatment (ART). Mobile dental services are more cost-effective than stationary clinics, but the costs of acquiring, outfitting, and running a mobile dental truck are factors that may hamper the broader use of this model. ART on the other hand is easy to execute with minimal equipment and monetary resources. But the drawback is a typically lower survival rate of ART restorations compared to conventional placed restorations.

This study aims to further assess and compare the performance and cost-effectiveness of glass-ionomer restorations when placed using either ART (in a classroom) or conventional (in a mobile clinic) cavity preparation in South African school children stemming from a periurban area. The results of this research may help to assess and implement future oral health care programs.

Enrollment: 200 estimated patients

Sex: All

Ages: 4 to 8 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

General Inclusion Criteria:

• Children (4-8 years of age)
• Guardians have given informed consent
• Child is cooperative and assented

Inclusion criteria for teeth

• 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

Exclusion criteria for teeth

• Cavity > 1 mm
• Tooth has no pathological mobility

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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200 participants in 2 patient groups

Atraumatic Restorative Treatment (ART)

Experimental group

Description:

GIC restorations placed using ART in a class room.

Treatment:

Procedure: Atraumatic Restorative Treatment (ART)

Conventional Cavity Preparation

Active Comparator group

Description:

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

Treatment:

Procedure: Conventional Cavity Preparation