Clinical trial NCT05766696: Survival Rate and Cost-effectiveness of Conventional vs ART Restorations in a School Setting
Official title: Survival Rate and Cost-effectiveness of Glass Ionomer Restorations in the Primary Molars Using ART and Conventional Cavity Preparations in South African Children: a Randomized Controlled Non Inferiority Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Dental Caries
Keywords: Glass Ionomer Cements
Atraumatic Restorative Treatment
Cost Effectiveness
Oral Health
Lead sponsor: DMG Dental Material Gesellschaft mbH
Sponsor class: INDUSTRY
First posted: 2023-03-13
Enrollment: 200
Sex: ALL
Minimum age (years): 4
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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).
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Detailed 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.

Eligibility 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

Primary outcomes:
measure: Survival rate of posterior occlusal multi-surface restorations
timeFrame: 24 months
Secondary outcomes:
measure: Survival rate of restorations depending on lesion type (occlusal single surface, occlusal multi surface and approximal restorations)
timeFrame: 6, 12 and 24 months
measure: Incremental cost-effectiveness ratio (ICER)
timeFrame: 6, 12 and 24 months
Other outcomes:
measure: Lesion size
timeFrame: Intervention at baseline
measure: Treatment time (continuous outcome, minutes)
timeFrame: Intervention at baseline
Locations:
city: Mfuleni
country: South Africa
facility: Nyameko and Itsitsa Primary Schools
state: Western Cape
Study officials:
References: