Two Preventive Measures on Caries Progression in Mixed Dentition Patients. (NCT06119126) | Clinical Trial Compass
CompletedPhase 2
Two Preventive Measures on Caries Progression in Mixed Dentition Patients.
Egypt23 participantsStarted 2020-06-01
Plain-language summary
Primary Objective:
Assessing the clinical effect of SDF and Laser on the prevention of initial caries progression with and without pits and fissure sealants in both permanent and primary molars.
Secondary Objective:
Effect of SDF and Laser Application on the subsequently applied pits and fissure sealants.
Who can participate
Age range
6 Years – 9 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 6-9 years old.
.Patients categorized as moderate to high caries risk (deft index \>1) showing more than 1 new carious lesions or restorations in the last 36 months according to "ADA Caries Risk Assessment Form (Age \>6)" .A split mouth study design was followed where all four second molars were selected for intervention in the primary molar group, while all first molars were selected for intervention in the permanent molar group.
.The four molars selected in each patient (primary / permanent) should be fully erupted with no gingival overhangs /operculum and with no history of previous restorations or prior sealants.
.According to International Caries Detection and Assessment System ICDAS grading, molars with (0, 1, 2) scores only were included.
Exclusion Criteria:
.Uncooperative or mentally challenged patients, with bad oral hygiene or rampant caries.
.Patients providing history of bruxism or clenching affecting the posterior occlusion were excluded.
.Children with known allergies or sensitivities to resins or silver products. .Molars that showed well-coalesced, self-cleansing pits \& fissures or shallow grooves and severe forms of hypoplasia / fluorosis were excluded.
.Patients \& parents with high esthetic demands and concerns. .Unmotivated patients, or parents who refused to sign the consent form.
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.