Atraumatic Versus Silver-Modified Atraumatic Restorative Treatment in Primary Molars (NCT07023939) | Clinical Trial Compass
CompletedPhase 4
Atraumatic Versus Silver-Modified Atraumatic Restorative Treatment in Primary Molars
Lebanon34 participantsStarted 2023-05-02
Plain-language summary
The goal of this clinical trial is to evaluate and compare the short-term effectiveness of two minimally invasive treatments-Atraumatic Restorative Treatment (ART) and Silver-Modified Atraumatic Restorative Treatment (SMART)-in managing dentine caries lesions in the primary molars of children aged 3 to 7 years with Early Childhood Caries (ECC). The main questions it aims to answer are:
* Which treatment method (ART or SMART) results in higher clinical success after six months?
* How do ART and SMART treatments affect the Oral Health-Related Quality of Life (OHRQoL) of the children? The researcher will compare teeth restored using ART with those treated using SMART (which includes the application of silver diamine fluoride before restoration) to see if one approach leads to better restoration outcomes and to assess how these restorations will impact the quality of life.
Participants will:
* Receive both types of treatments in different teeth (split-mouth design).
* Undergo clinical evaluation of the treated teeth at baseline and six months to assess success based on restoration retention, integrity, and absence of secondary caries.
* Have their parents complete a quality-of-life questionnaire (A-ECOHIS) at the start and at the six-month follow-up.
Who can participate
Age range
3 Years – 7 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:
* Study Participants: Generally healthy children aged 3 to 7 years
* Behavior Rating (Frankel's Scale):
Negative (Score 2) Positive (Score 3)
* Dental Condition: At least two bilateral asymptomatic decayed primary molars
* Caries Classification: based on International caries detection and assessment systemII I(CDAS II) Scores 4 \& 5 (Occlusal or occluso-proximal carious dentin lesions)
Exclusion Criteria:
* Children with systemic diseases/conditions (ASA Type I)
* Behavior Rating (Frankel's Scale) Definitely positive(Score 1) Definitely negative (Score 4).
* Teeth showing irreversible pulpitis or pulpal pathology (abscess, fistula, mobility)
* Teeth with very deep cavities or score 6 based on ICDAS II
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
primary outcome : Success rate of restorations assessed by Modified ART Criteria