Reducing pain after pulpotomy in children using EndoCem with or without laser therapy
Evaluation of Postoperative Pain After Pulpotomy Using Calcium Silicate Cements in Permanent Molars With and Without Laser Biomodulation: A Randomized Clinical Trial
This trial tests whether adding a gentle Er,Cr:YSGG laser to pulpotomy sealed with EndoCem reduces postoperative pain in children aged 9–14 with painful permanent lower molars.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 46 (estimated) |
| Ages | 9 Years to 14 Years |
| Sex | All |
| Sponsor | University of Fujairah Academic / other |
| Locations | 1 site (Fujairah, Emirate of Fujairah) |
| Trial ID | NCT07290049 on ClinicalTrials.gov |
What this trial studies
This is a prospective, triple-blind, randomized controlled trial with two parallel arms and a 1:1 allocation comparing full pulpotomy with EndoCem alone versus EndoCem plus non‑ablative Er,Cr:YSGG laser biomodulation. Eligible participants are children and young adolescents (9–14 years) with restorable two‑rooted mandibular molars diagnosed with symptomatic irreversible pulpitis. After pulpotomy and hemostasis, patients will be randomized to receive either the laser application to the radicular pulp stumps followed by EndoCem or EndoCem alone, and postoperative pain will be tracked using standardized pain measures. The design tests whether adjunctive laser biomodulation can reduce pain and improve short‑term outcomes after vital pulp therapy.
Who should consider this trial
Good fit: Ideal candidates are 9–14 year olds with a restorable, periodontally healthy two‑rooted lower permanent molar diagnosed with symptomatic irreversible pulpitis who can attend the Fujairah clinic and provide consent.
Not a fit: Patients with immature roots, necrotic or nonrestorable teeth, uncontrolled bleeding during the procedure, significant medical comorbidities, or inability to consent are unlikely to benefit from this trial.
Why it matters
Potential benefit: If successful, the approach could lower postoperative pain and support wider use of less invasive pulpotomy procedures that preserve tooth vitality.
How similar studies have performed: There is growing evidence that calcium silicate (bioceramic) pulpotomy materials perform well for vital pulp therapy, while adjunctive low‑level laser biomodulation in this setting has limited and mixed preliminary data.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: Patients between 9 and 14 years of age. Must have a two-rooted mandibular molar tooth (lower back tooth). The tooth must be diagnosed with symptomatic irreversible pulpitis (a painful, inflamed nerve). The tooth must be considered restorable (can be fixed with a filling or crown). Patient and/or guardian must be able to understand and sign the informed consent form. The tooth must be periodontally healthy, with no mobility, and not painful to tapping or pressing. Exclusion Criteria: Teeth with immature root tips. Teeth that are not restorable (severely damaged or decayed). Bleeding from the tooth's nerve that cannot be controlled within 10 minutes during the procedure. Patients with significant medical conditions that could complicate dental treatment. Teeth with a dead (necrotic) nerve. Inability or unwillingness to provide informed consent. Individuals from vulnerable groups (as defined by the ethics committee).
Where this trial is running
Fujairah, Emirate of Fujairah
- Dental Clinic, College of Dentistry, Fujairah University — Fujairah, Emirate of Fujairah, United Arab Emirates (Recruiting)
Study contacts
- Principal investigator: Mohamed Medhat Kataia, PhD — Fujairah University
- Study coordinator: Nabeel Ayappali Kalluvalappil, MDS
- Email: n.kalluvalappil@fu.ac.ae
- Phone: +97192023517
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.