Evaluation of Postoperative Pain After Pulpotomy Using Calcium Silicate Cements in Permanent Molars With and Without Laser Biomodulation: A Randomized Clinical Trial

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

This study is for children and young adults who have a severe toothache in a permanent back molar, caused by an inflamed nerve (a condition called irreversible pulpitis). Usually, the treatment for this is a root canal, which removes the entire nerve. However, a different treatment called vital pulp therapy or pulpotomy may be an option. This simpler procedure removes only the infected part of the nerve, leaving the healthy part alive, and then seals the tooth with a special material. The goal of our research is to see if we can make this pulpotomy procedure even more comfortable for patients afterward. We are testing two approaches: Using a modern dental filling material called EndoCem to seal the tooth. Using the same EndoCem material, but first applying a gentle laser to the healthy nerve tissue. This laser treatment, known as biomodulation, is thought to help calm the tissue and improve healing. Patients who join the study will be randomly assigned to one of these two treatment groups. The main thing we will measure is the level of pain after the procedure, which patients will record on a simple pain scale. We want to find out if using the laser in addition to the filling material leads to less pain and a better experience after the treatment. This study will help dentists understand if combining this new sealing material with laser therapy can be a more effective and comfortable way to save a tooth with a severe toothache.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 9
Maximum Age: 14
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
United Arab Emirates
Dental Clinic, College of Dentistry, Fujairah University
RECRUITING
Fujairah
Contact Information
Primary
Nabeel Ayappali Kalluvalappil, MDS
n.kalluvalappil@fu.ac.ae
+97192023517
Time Frame
Start Date: 2025-04-24
Estimated Completion Date: 2026-01-25
Participants
Target number of participants: 46
Treatments
Active_comparator: EndoCem Pulpotomy
Participants in this arm will receive a full pulpotomy procedure for the treatment of symptomatic irreversible pulpitis. Following coronal pulp removal and hemostasis, the vital radicular pulp tissue will be covered with the calcium silicate cement EndoCem (ZTM Medicare, Pre-mixed MTA Putty), applied according to the manufacturer's instructions. The tooth will then receive a final restoration. This arm serves as the active comparator, evaluating the standard vital pulp therapy protocol using a modern bioceramic material.
Experimental: EndoCem + Laser Pulpotomy
Participants in this arm will receive an identical full pulpotomy procedure. However, prior to the placement of the EndoCem cement, the exposed radicular pulp stumps will undergo Er,Cr:YSGG laser biomodulation. The laser will be applied in a non-ablative, biostimulatory mode using specific parameters (e.g., 1.0 W, 20 Hz, 50 mJ, 60% water, 70% air) for a predetermined duration to achieve the biomodulation effect. Following laser application, EndoCem cement is placed and the tooth is restored. This is the experimental arm investigating the adjunctive effect of laser therapy.
Related Therapeutic Areas
Sponsors
Leads: University of Fujairah

This content was sourced from clinicaltrials.gov