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

NCT07290049 | Recruiting DMC

• 1 other identifier: UOF REC2025-04-22
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief 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 (SIP); Symptomatic Irreversible Pulpitis

Keywords

Vital Pulp Therapy; Pulpotomy; Irreversible Pulpitis; Postoperative Pain; Calcium Silicate Cement; Bioceramic; Laser Biomodulation; Er,Cr:YSGG Laser; EndoCem; Biodentine; Randomized Controlled Trial

Outcome Measures

Primary Outcomes (1)

• Postoperative Pain Intensity as assessed by Visual Analogue Scale (VAS)

  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 Outcomes (2)

• Clinical Success Rate

  At 1 week and 6 months post-treatment.

• Radiographic Success Rate

  At 6 months post-treatment.

Other Outcomes (1)

• Incidence of Analgesic Medication Use

  Within 48 hours after the completion of the pulpotomy procedure.

Study Arms (2)

EndoCem Pulpotomy

ACTIVE COMPARATOR

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

EndoCem + Laser Pulpotomy

EXPERIMENTAL

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; Device: Er,Cr:YSGG Laser

Interventions

Calcium Silicate Cement DEVICE

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.

EndoCem + Laser Pulpotomy; EndoCem Pulpotomy

Er,Cr:YSGG Laser DEVICE

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.

EndoCem + Laser Pulpotomy

Eligibility Criteria

• Age: 9 Years - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• University of Fujairah: lead

Study Sites (1)

Dental Clinic, College of Dentistry, Fujairah University

Fujairah, Emirate of Fujairah, 2202, United Arab Emirates

RECRUITING

Related Publications (8)

• Hanna SN, Perez Alfayate R, Prichard J. Vital Pulp Therapy an Insight Over the Available Literature and Future Expectations. Eur Endod J. 2020 Mar 1;5(1):46-53. doi: 10.14744/eej.2019.44154. eCollection 2020.

  PMID: 32342038 BACKGROUND

• Kim M, Yang W, Kim H, Ko H. Comparison of the biological properties of ProRoot MTA, OrthoMTA, and Endocem MTA cements. J Endod. 2014 Oct;40(10):1649-53. doi: 10.1016/j.joen.2014.04.013. Epub 2014 Jul 19.

  PMID: 25052144 BACKGROUND

• Kaur M, Singh H, Dhillon JS, Batra M, Saini M. MTA versus Biodentine: Review of Literature with a Comparative Analysis. J Clin Diagn Res. 2017 Aug;11(8):ZG01-ZG05. doi: 10.7860/JCDR/2017/25840.10374. Epub 2017 Aug 1.

  PMID: 28969295 BACKGROUND

• Drouri S, El Merini H, Sy A, Jabri M. Evaluation of Direct and Indirect Pulp Capping With Biodentine in Vital Permanent Teeth With Deep Caries Lesions. Cureus. 2023 May 23;15(5):e39374. doi: 10.7759/cureus.39374. eCollection 2023 May.

  PMID: 37250608 BACKGROUND

• Stanley HR. Pulp capping: conserving the dental pulp--can it be done? Is it worth it? Oral Surg Oral Med Oral Pathol. 1989 Nov;68(5):628-39. doi: 10.1016/0030-4220(89)90252-1.

  PMID: 2682429 BACKGROUND

• Caplan DJ, Cai J, Yin G, White BA. Root canal filled versus non-root canal filled teeth: a retrospective comparison of survival times. J Public Health Dent. 2005 Spring;65(2):90-6. doi: 10.1111/j.1752-7325.2005.tb02792.x.

  PMID: 15929546 BACKGROUND

• AAE Position Statement on Vital Pulp Therapy. J Endod. 2021 Sep;47(9):1340-1344. doi: 10.1016/j.joen.2021.07.015. Epub 2021 Aug 3. No abstract available.

  PMID: 34352305 BACKGROUND

• Rebel, H-H. (1922). "über die Ausheilung der freigelegten pulpa". Ditsch Zahnheilkd.

  BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Mohamed Medhat Kataia, PhD

  Fujairah University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nabeel Ayappali Kalluvalappil, MDS

CONTACT

+97192023517; n.kalluvalappil@fu.ac.ae

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The operating clinician performing the pulpotomy procedure cannot be blinded due to the nature of the laser intervention. However, to maintain blinding, this clinician will not be involved in postoperative assessments. The participant, the independent assessor who collects the pain scores (Outcomes Assessor), and the statistician analyzing the final data will all be unaware of the group assignments.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a two-arm, parallel-group study. Participants are randomly assigned to one of two intervention groups and remain in that group for the entirety of the study. The groups are treated concurrently, and their outcomes are compared directly to each other. Group 1 (Control): Receives the standard pulpotomy procedure using the calcium silicate cement (EndoCem). Group 2 (Intervention): Receives the standard pulpotomy procedure with the addition of laser biomodulation prior to the placement of the calcium silicate cement (EndoCem). There is no crossover or sequential assignment of interventions.

Study Record Dates

• First Submitted: December 4, 2025
• First Posted: December 17, 2025
• Study Start: April 24, 2025
• Primary Completion: December 25, 2025
• Study Completion: January 25, 2026
• Last Updated: December 17, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

AE (1)