Laser versus conventional pulpotomy for mature molars with irreversible pulpitis
Evaluation Of Laser Versus Conventional Pulpotomies In Mature Molar Teeth With Irreversible Pulpitis (A Randomized Controlled Clinical Trial)
This trial will test two types of laser-assisted pulpotomy against conventional pulpotomy in adults with symptomatic irreversible pulpitis in permanent molars to see which reduces pain and improves healing.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 16 Years to 50 Years |
| Sex | All |
| Sponsor | Alexandria University Academic / other |
| Locations | 1 site (Alexandria) |
| Trial ID | NCT07287709 on ClinicalTrials.gov |
What this trial studies
Sixty restorable permanent molars with symptomatic irreversible pulpitis will be randomized into three groups receiving photobiomodulation pulpotomy, photocoagulation pulpotomy, or conventional pulpotomy, and all teeth will be capped with bioceramic putty. Postoperative pain will be recorded at 24, 48 and 72 hours and at one week using a numerical rating scale, and clinical plus periapical radiographic assessments will occur at 1, 3, 6 and 12 months. Cone-beam CT scans will be taken immediately after treatment and at the end of follow-up to evaluate dentin bridge formation, and automated segmentation using artificial intelligence will quantify changes in radicular pulp volume. The trial compares clinical pain, radiographic healing, and CBCT-derived pulp metrics to determine whether laser methods offer improved outcomes over conventional pulpotomy.
Who should consider this trial
Good fit: Adults aged 16–50 with restorable permanent molars diagnosed with symptomatic irreversible pulpitis, PAI scores 1–2, ASA I–II, and willingness to attend follow-up visits are ideal candidates.
Not a fit: Patients with necrotic pulp, open apices, root resorption, high periapical scores (PAI 3–5), uncontrolled medical conditions, or pregnancy are excluded and would not be expected to benefit from this protocol.
Why it matters
Potential benefit: If successful, laser-assisted pulpotomy could reduce postoperative pain and enhance pulp healing, potentially preserving more natural tooth structure and avoiding the need for full root canal therapy.
How similar studies have performed: Small prior studies have shown promising but mixed results for laser-assisted pulpotomy, while the use of CBCT with AI-driven segmentation to measure pulp volume changes represents a novel element.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Permanent molar teeth with symptomatic irreversible pulpitis. * The patient should be ≥ 16 to 50 years old. * Teeth should give positive response to cold testing and clinical diagnosis of SIP with or without periapical rarefaction. * Teeth will be selected only if they are restorable. * Patient medically healthy and free from systemic diseases. ASA I, II. * patients who agreed to participate in the study to attend the control visits. * Teeth with periapical index score (PAI) 1 and 2 will be selected Exclusion Criteria: * Teeth with necrotic pulp, resorption or subgingival caries. * Teeth with open apices. * Medically compromised patients. * Pregnant patients. * Patients with uncontrollable bleeding from the radicular pulp. * Patients with (PAI) score 3-5 will be excluded from the study
Where this trial is running
Alexandria
- Faculty of Dentistry — Alexandria, Egypt (Recruiting)
Study contacts
- Principal investigator: Rania Noaman ELbackly, Professor — Endodontics, Conservative Dentistry Department, Faculty of Dentistry, Alexandria University, Alexandria, Egypt. Tissue Engineering Laboratories, Faculty of Dentistry, Alexandria University, Alexandria, Egypt.
- Study coordinator: Rana Mahmoud Hegazi, Assistant lecturer
- Email: ranahegazi1991@gmail.com
- Phone: 01094428209
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.