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

July 20, 2026 updated by: University of Fujairah

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

This study evaluates treatment options for children and young adults with severe toothache in a permanent molar caused by symptomatic irreversible pulpitis. Conventional treatment involves non-surgical root canal treatment, which removes the entire dental pulp. An alternative approach, vital pulp therapy (full pulpotomy), removes only the inflamed coronal pulp while preserving the healthy radicular pulp, followed by placement of a bioactive calcium silicate cement.

The study compares two pulpotomy protocols. One group will receive EndoCem as the pulpal dressing material, while the other group will receive Er,Cr:YSGG laser biomodulation of the remaining pulp tissue before placement of EndoCem. Laser biomodulation is intended to reduce inflammation and promote tissue healing.

Participants will be randomly assigned to one of the two treatment groups. The primary outcome is postoperative pain, which will be assessed using a Visual Analogue Scale (VAS) at predetermined time points after treatment. The study aims to determine whether adjunctive laser biomodulation reduces postoperative pain compared with EndoCem alone and improves patient comfort following full pulpotomy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This study is a prospective, triple-blind, randomized controlled trial with two parallel arms and a 1:1 allocation ratio. The trial investigates the efficacy of adjunctive Er,Cr:YSGG laser biomodulation in reducing postoperative pain following full pulpotomy in permanent molars diagnosed with symptomatic irreversible pulpitis.

Non-surgical root canal treatment has traditionally been the standard treatment for symptomatic irreversible pulpitis because it involves complete removal of the dental pulp. However, advances in bioactive calcium silicate materials have established vital pulp therapy, particularly full pulpotomy, as a biologically conservative treatment option for mature permanent teeth. Full pulpotomy preserves the vitality of the radicular pulp while maintaining the tooth's biological defense mechanisms and proprioception and can be completed with less procedural complexity than conventional root canal treatment.

The study material is EndoCem, a premixed calcium silicate cement with favorable biocompatibility, bioactivity, and sealing ability. The experimental intervention consists of applying Er,Cr:YSGG laser energy to the exposed radicular pulp tissue after hemostasis and before placement of EndoCem. The laser will be operated in a non-ablative biomodulation mode. The proposed biological effects include stimulation of pulpal cells, enhancement of local microcirculation, modulation of inflammatory responses, and promotion of tissue healing, which may reduce postoperative pain.

Eligible participants presenting to the outpatient clinic will be screened according to the study eligibility criteria. Following informed consent, participants will be randomly assigned to one of two groups:

Group 1 (Control): Full pulpotomy followed by placement of EndoCem cement and definitive restoration.

Group 2 (Intervention): Full pulpotomy followed by Er,Cr:YSGG laser biomodulation of the radicular pulp tissue, placement of EndoCem cement, and definitive restoration.

The randomization sequence will be computer-generated, and allocation concealment will be maintained using sequentially numbered, opaque, sealed envelopes. The operating clinician will not participate in postoperative outcome assessment. Participants, outcome assessors, and the statistician will remain blinded to treatment allocation throughout the study.

The primary outcome is postoperative pain, measured using a Visual Analogue Scale (VAS). Pain scores will be recorded at predefined postoperative time points, including 6, 12, 24, and 48 hours. Mean pain scores and the incidence of moderate-to-severe pain will be compared between the two study groups.

The findings are expected to provide evidence regarding the effectiveness of adjunctive Er,Cr:YSGG laser biomodulation when combined with EndoCem during full pulpotomy. The results may contribute to optimizing vital pulp therapy protocols and improving postoperative patient comfort while supporting conservative management of symptomatic irreversible pulpitis.

Study Type

Interventional

Enrollment (Actual)

46

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Arab Emirates
    • Emirate of Fujairah
      • Fujairah, Emirate of Fujairah, United Arab Emirates, 2202
        • Dental Clinic, College of Dentistry, Fujairah University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients between 9 and 14 years of age
  • Presence of a two-rooted permanent mandibular molar
  • Clinical diagnosis of symptomatic irreversible pulpitis in the study tooth
  • Study tooth considered restorable with a definitive restoration
  • Study tooth is periodontally healthy, with no mobility and no tenderness to percussion or palpation
  • Participant and/or parent/legal guardian is able and willing to provide written informed consent

Exclusion Criteria:

  • Teeth with immature root apices
  • Teeth that are non-restorable because of extensive caries or structural damage
  • Inability to achieve hemostasis within 10 minutes after coronal pulp removal
  • Participants with significant systemic medical conditions that may affect dental treatment or healing
  • Teeth diagnosed with pulpal necrosis
  • Inability or unwillingness of the participant and/or parent/legal guardian to provide informed consent
  • Individuals belonging to vulnerable populations, as defined by the institutional ethics committee

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
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.
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative Pain Intensity as assessed by Visual Analogue Scale (VAS)
Time Frame: At 6, 12, 24, and 48 hours after the completion of the pulpotomy procedure.
Postoperative pain level will be self-reported by participants using a 100-mm Visual Analogue Scale (VAS). The scale is a horizontal line anchored by two verbal descriptors: "No pain" (0 mm) on the left and "Worst pain imaginable" (100 mm) on the right. Participants mark the line at the point that best represents their pain intensity. A higher score indicates greater pain. The outcome for analysis is the mean VAS score recorded at each specified postoperative time point.
At 6, 12, 24, and 48 hours after the completion of the pulpotomy procedure.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical Success Rate
Time Frame: At 1 week and 6 months post-treatment.
The absence of clinical signs and symptoms of failure, including spontaneous pain, pain on palpation, pain on percussion, soft tissue swelling, sinus tract, or pathological tooth mobility. The outcome is reported as the number of participants with a clinically successful outcome.
At 1 week and 6 months post-treatment.
Radiographic Success Rate
Time Frame: At 6 months post-treatment.
The absence of radiographic signs of failure, assessed via periapical radiographs. This includes the absence of new or enlarged periapical radiolucency, external or internal root resorption, or periodontal ligament space widening. The outcome is reported as the number of participants with a radiographically successful outcome.
At 6 months post-treatment.

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of Analgesic Medication Use
Time Frame: Within 48 hours after the completion of the pulpotomy procedure.
The number of participants who take rescue analgesic medication (e.g., Ibuprofen) for pain relief following the procedure. This is used as an indirect, patient-driven measure of significant postoperative pain.
Within 48 hours after the completion of the pulpotomy procedure.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Fujairah

Investigators

  • Principal Investigator: Mohamed Medhat Kataia, PhD, Fujairah University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 24, 2025

Primary Completion (Actual)

April 25, 2026

Study Completion (Actual)

June 25, 2026

Study Registration Dates

First Submitted

December 4, 2025

First Submitted That Met QC Criteria

December 4, 2025

First Posted (Actual)

December 17, 2025

Study Record Updates

Last Update Posted (Actual)

July 22, 2026

Last Update Submitted That Met QC Criteria

July 20, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UOF REC2025-04-22

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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