Composite Restoration of Class II Cavities in Primary Molars With or Without Pulpotomy. Prospecti… (NCT07243496) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Composite Restoration of Class II Cavities in Primary Molars With or Without Pulpotomy. Prospective 24 Month Clinical Trial.
Greece40 participantsStarted 2024-05-01
Plain-language summary
After 24 months:
* Investigation of the success rate of Class II composite resin restorations in primary molars that have undergone pulpotomy.
* Comparison of Class II composite resin restorations in primary molars that have undergone pulpotomy with restorations of the same type in the same patient, in which no pulpotomy has been performed.
The null hypothesis of the study is that there is no statistically significant difference in the success of Class II resin restorations after their placement in primary molars, regardless of whether a pulpotomy has been performed or not.
Who can participate
Age range
3 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:
* Healthy children aged 3-9 years
* At least one pulpotomy in a carious primary molar requiring a Class II resin restoration
* At least one Class II cavity in a carious primary molar in the same patient that requires a resin restoration
* The teeth to be restored must not present clinical signs of pulp necrosis, such as pathological mobility or abscess/fistula
* Parents have signed an informed consent form
* The young patients return for evaluation at 12 and 24 months
* There is no exfoliation or extraction of the evaluated teeth before the 24-month period
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
Modified USPHS criteria
Timeframe: Assessment is done at 12 and 24 months following placement of the composite restoration