Evaluating the use of laser therapy with MTA pulpotomy for treating tooth pulp issues in children
Clinical and Radiographic Assessment of Photobiomodulated MTA Pulpotomy in Immature First Permanent Molars with Irreversible Pulpitis: a Randomized Controlled Clinical Trial
This study is testing whether adding laser therapy to a common tooth treatment helps children aged 6-9 with serious pulp problems heal better and feel less pain.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 72 (estimated) |
| Ages | 6 Years to 9 Years |
| Sex | All |
| Sponsor | Mansoura University Academic / other |
| Locations | 1 site (Al Mansurah, Dakahlia Governorate) |
| Trial ID | NCT06730360 on ClinicalTrials.gov |
What this trial studies
This clinical trial assesses the effectiveness of combining photobiomodulation (PBM) with mineral trioxide aggregate (MTA) pulpotomy in treating irreversible pulpitis in immature first permanent molars in children aged 6-9 years. The study involves 72 participants divided into two groups: one receiving MTA pulpotomy alone and the other receiving MTA pulpotomy with PBM. The trial aims to evaluate clinical and radiographic outcomes over 15 months, focusing on healing, inflammation reduction, and pain management. By comparing these two treatment approaches, the research seeks to determine the potential benefits of PBM as an adjunctive therapy for vital pulp preservation in pediatric dentistry.
Who should consider this trial
Good fit: Ideal candidates are healthy children aged 6 to 9 years with irreversible pulpitis in their first permanent molars.
Not a fit: Patients with signs of pulpal necrosis or those with systemic conditions that contraindicate participation may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could enhance healing and reduce discomfort in children undergoing dental procedures for irreversible pulpitis.
How similar studies have performed: While the use of PBM in dental treatments is gaining interest, this specific combination with MTA pulpotomy has not been extensively tested, making it a novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Al Mansurah, Dakahlia Governorate
- Faculty of Dentistry — Al Mansurah, Dakahlia Governorate, Egypt (Recruiting)
Study contacts
- Study coordinator: peter samir abdelshahed, assistant lecture
- Email: petersamir@mans.edu.eg
- Phone: +201141859508
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.