Dental CariesNCT05766696
Survival Rate and Cost-effectiveness of Conventional vs ART Restorations in a School Setting
A study testing Atraumatic Restorative Treatment (ART) and Conventional Cavity Preparation in people with Dental Caries, run by DMG Dental Material Gesellschaft mbH at 1 site in South Africa.
Trial 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. Read more about this study
- Who is it for?
- Ages 4 to 8 years
- Conditions the study is for
- Dental Caries
- What is being tested?
- Atraumatic Restorative Treatment (ART) and Conventional Cavity Preparation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteSouth Africa
- Study dates
- 24 Feb 2025to Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 8 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- Cavity > 1 mm
- Tooth has no pathological mobility
Trial locations and contacts
1 site in 1 country.
South Africa1 site
Nyameko and Itsitsa Primary Schools
Mfuleni, Western Cape, 7100
About this study
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
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.
Read the 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.
- Conditions
- Dental Caries
- Being tested
- Atraumatic Restorative Treatment (ART), Conventional Cavity Preparation
- Keywords
- Glass Ionomer Cements, Atraumatic Restorative Treatment, Cost Effectiveness, Oral Health
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Atraumatic Restorative Treatment (ART)Procedure or surgery
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.
Conventional Cavity PreparationProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Atraumatic Restorative Treatment (ART) | Experimental | GIC restorations placed using ART in a class room. Receives: Procedure: Atraumatic Restorative Treatment (ART) |
| Conventional Cavity Preparation | Active comparator | GIC restorations placed using conventional cavity preparation in a mobile clinic. Receives: Procedure: Conventional Cavity Preparation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 24 months
Secondary outcomes (2)
Survival rate of restorations depending on lesion type (occlusal single surface, occlusal multi surface and approximal restorations)
Restorations are divided in the subgroups "occlusal single surface", "occlusal multi surface" and "approximal restorations" and 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)
Measured: 6, 12 and 24 months
Incremental cost-effectiveness ratio (ICER)
Incremental cost-effectiveness ratio will be calculated as "difference in costs of failures / difference in failures" to assess "cost/ savings per failure prevented".
For costing, a payers perspective will be assumed and costing will be calculated on a "per restoration" basis. For this material, transport, personnel and equippment costs will be assessed. All materials used in each procedure will have their specifications and quantity registered. Capital costs will be annualized and the proportion of time it took to complete the intervention will be calculated and applied to the annualized capital costs to estimate the cost per restoration. Prices will be inferences from the market value converted in US Dollars and obtained by the medium of the values from different places that commercialized the referred products.
Measured: 6, 12 and 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2023
- Study start24 Feb 2025
- Primary completionFeb 2027 (estimated)
- Study completionFeb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental CariesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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).
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- DMG Dental Material Gesellschaft mbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05766696
- Sponsor's protocol ID
- DeltaART
- Status last verified
- Apr 2026
- First submitted
- 2 Mar 2023
- Last updated
- 13 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05766696
- Acronym / sponsor ID
- DeltaART
- Conditions
- Dental Caries
- Keywords
- Glass Ionomer Cements, Atraumatic Restorative Treatment, Cost Effectiveness, Oral Health
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- DMG Dental Material Gesellschaft mbHIndustry (pharma, biotech, devices)
- Study start
- 24 Feb 2025 (actual)
- Primary completion
- Feb 2027 (estimated)
- Study completion
- Feb 2027 (estimated)
- First posted
- 13 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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).
| Arm | Type | Receives |
|---|---|---|
| Atraumatic Restorative Treatment (ART) | Experimental | Procedure: Atraumatic Restorative Treatment (ART)GIC restorations placed using ART in a class room. |
| Conventional Cavity Preparation | Active comparator | Procedure: Conventional Cavity PreparationGIC restorations placed using conventional cavity preparation in a mobile clinic. |
Who may qualify
- Ages
- 4 to 8 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- Cavity > 1 mm
- Tooth has no pathological mobility
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Atraumatic Restorative Treatment (ART)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. | Procedure or surgery | Atraumatic Restorative Treatment (ART) |
| Conventional Cavity PreparationConventional 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. | Procedure or surgery | Conventional Cavity Preparation |
Primary outcome
Survival rate of posterior occlusal multi-surface restorations
Time frame: 24 months
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)
2 secondary outcomes
Survival rate of restorations depending on lesion type (occlusal single surface, occlusal multi surface and approximal restorations)
Time frame: 6, 12 and 24 months
Incremental cost-effectiveness ratio (ICER)
Time frame: 6, 12 and 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Atraumatic Restorative Treatment (ART) and Conventional Cavity Preparation in people with Dental Caries, run by DMG Dental Material Gesellschaft mbH at 1 site in South Africa.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Africa. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Survival rate of posterior occlusal multi-surface restorations (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2026.