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Postoperative Pain After Pulpotomy in Children Using Calcium Silicate Cements With and Without Laser Therapy

NCT07290049 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 46

Last updated 2025-12-17

No results posted yet for this study

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.

Conditions

  • Symptomatic Irreversible Pulpitis
  • Symptomatic Irreversible Pulpitis (SIP)

Interventions

DEVICE

Calcium Silicate Cement

A premixed, ready-to-use hydraulic tricalcium silicate cement (commercial name: EndoCem MTA Pre-mixed Putty) used as a direct pulp-capping agent. It is applied over the vital radicular pulp tissue following a pulpotomy procedure to seal the pulp chamber and promote healing and reparative dentin formation. The material is used according to the manufacturer's instructions for vital pulp therapy.

DEVICE

Er,Cr:YSGG Laser

An Erbium, Chromium: Yttrium-Scandium-Gallium-Garnet laser system used in a non-ablative, low-level power setting for biomodulation. Following hemostasis in the pulpotomy procedure, the laser tip delivers photonic energy to the exposed pulp stumps in a defocused, non-contact mode. The intended biological effects are biostimulation of pulpal cells, enhanced healing, and anti-inflammatory action, which may reduce postoperative pain. Specific parameters (e.g., power, frequency, air/water coolant ratio) are set for therapeutic bio-stimulation rather than surgical cutting.

Sponsors & Collaborators

  • University of Fujairah

    lead OTHER

Principal Investigators

  • Mohamed Medhat Kataia, PhD · Fujairah University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
9 Years
Max Age
14 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-04-24
Primary Completion
2025-12-25
Completion
2026-01-25

Countries

  • United Arab Emirates

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07290049 on ClinicalTrials.gov