Clinical and Radiographic Assessment of Photobiomodulated MTA Pulpotomy in Immature First Permane… (NCT06730360) | Clinical Trial Compass
RecruitingNot Applicable
Clinical and Radiographic Assessment of Photobiomodulated MTA Pulpotomy in Immature First Permanent Molars with Irreversible Pulpitis
Egypt72 participantsStarted 2024-10-10
Plain-language summary
This study evaluates the effectiveness of photobiomodulation (PBM) in conjunction with mineral trioxide aggregate (MTA) pulpotomy for treating irreversible pulpitis in immature first permanent molars. PBM, also known as low-level laser therapy (LLLT), is used to enhance healing, reduce inflammation, and manage pain in young teeth. The randomized clinical trial involves 72 children aged 6-9 years, divided into two groups: one receiving MTA pulpotomy alone and the other receiving MTA pulpotomy with PBM. Clinical and radiographic outcomes will be assessed at intervals over 15 months. This research aims to determine the combined therapy's efficacy in improving pulp healing and reducing post-operative discomfort compared to MTA alone.
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 to 9 years.
* Non-contributory medical history (healthy otherwise).
* Presence of carious first permanent molars with the following characteristics:
* Deep caries extending to ≥2/3 of dentin.
* Positive response to cold testing.
* Clinical diagnosis of irreversible pulpitis (moderate or severe), with or without periapical periodontitis.
* Restorable tooth.
* Probing pocket depth and mobility within normal limits.
* No signs of pulpal necrosis, including sinus tract or swelling.
Exclusion Criteria:
* Insufficient bleeding after pulp exposure (indicating necrotic or partially necrotic pulp).
* Presence of systemic or medical conditions that may contraindicate participation.
* Teeth with unrestorable structure.
* Teeth showing signs of pulpal necrosis, such as the presence of a sinus tract or swelling.
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
Clinical Success of Pulpotomy Treatment
Timeframe: 15 months post-treatment (assessed at 3, 6, 12, and 15 months).