ART and Hall Technique for Management of Occlusal-proximal Caries in Primary Molars (NCT02569047) | Clinical Trial Compass
CompletedNot Applicable
ART and Hall Technique for Management of Occlusal-proximal Caries in Primary Molars
131 participantsStarted 2015-10
Plain-language 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.
Who can participate
Age range
5 Years – 10 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* children aged between 5 and 10 years
* cooperative behavior
* presenting good health conditions
* whose parents or legal guardians accept and sign the consent form
* with at least one occluso-proximal lesion in primary molar
* only occlusal-proximal surfaces with caries lesions with dentin involvement
* cavities accessible to hand instruments used in ART
* absence of fistula or abscess near the selected tooth
* absence of pulp exposure in the selected tooth
* absence of mobility in the selected tooth
* cavity size in the selected tooth not be bigger than 2.0 mm in the mesial-distal and 2.5 in the occlusal-cervical and bucco-lingual directions.
Exclusion Criteria:
* children younger than 5 years and older than 10
* non-cooperative behavior
* without good health conditions
* whose parents or legal guardians did not accepted and signed the consent form
* without any occluso-proximal lesion in primary molar
* caries in the selected tooth reaching other surfaces (than occlusal-proximal surface)
* occlusal-proximal surface with caries without dentin involvement
* cavities not accessible to hand instruments
* fistula or abscess near the selected tooth
* pulp exposure in the selected tooth
* mobility in the selected tooth
* cavity size bigger than 2.0 mm in the mesial-distal and 2.5 in the occlusal-cervical and - bucco-lingual directions.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
The restoration survival (changes from baseline up to 36 months)
Timeframe: The treatments will be evaluated after 1 week up to 36 months