Postoperative Pain After Pulpotomy in Children Using Calcium Silicate Cements With and Without Laser Therapy
NCT ID: NCT07290049
Last Updated: 2025-12-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
46 participants
INTERVENTIONAL
2025-04-24
2026-01-25
Brief Summary
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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.
Detailed Description
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The standard of care for teeth with this diagnosis has traditionally been non-surgical root canal treatment (NSRCT), which involves the complete removal of the dental pulp. However, with the advent of advanced bioceramic materials like calcium silicate cements, Vital Pulp Therapy (VPT), specifically pulpotomy, has emerged as a scientifically valid treatment alternative for mature permanent teeth. Pulpotomy aims to preserve the vitality and health of the radicular pulp tissue, potentially offering biological advantages such as maintaining the tooth's proprioceptive and defensive mechanisms, while also being a less complex and more time-efficient procedure.
The primary material under investigation is EndoCem, a premixed, ready-to-use calcium silicate cement. These materials are favored in VPT due to their excellent bioactivity, biocompatibility, and ability to form a hermetic seal over the vital pulp tissue. The experimental intervention involves the application of Er,Cr:YSGG laser energy to the exposed radicular pulp stumps following hemostasis, prior to the placement of the EndoCem cement. The laser parameters will be set to a non-ablative, bio-stimulatory mode. The proposed mechanism of action includes biostimulation of pulpal fibroblasts and stem cells, enhanced local microcirculation, and anti-inflammatory effects, which collectively may lead to a more favorable and less painful postoperative healing response.
Participants will be recruited from the patient pool presenting at the outpatient clinic. After screening against the eligibility criteria, eligible participants (or their guardians) who provide informed consent will be randomized into one of two groups:
Group 1 (Control): Will receive a full pulpotomy procedure followed by the application of EndoCem cement as the pulpal medicament and final restoration.
Group 2 (Intervention): Will receive an identical full pulpotomy procedure, followed by Er,Cr:YSGG laser biomodulation of the pulp stumps, and then the application of EndoCem cement and final restoration.
The randomization sequence will be computer-generated, and allocation concealment will be ensured using sequentially numbered, opaque, sealed envelopes. To maintain blinding, the operating clinician will not be involved in postoperative assessments. The participant, the outcome assessor (who collects the pain scores), and the statistician analyzing the data will all be blinded to the group assignments.
The primary outcome is postoperative pain, which will be quantitatively measured using a Visual Analogue Scale (VAS). Participants will record their pain levels at predetermined time points following the procedure (e.g., 6, 12, 24, and 48 hours). The data will be analyzed to compare the mean pain scores and the incidence of moderate-to-severe pain between the two groups over time.
This study aims to provide high-level evidence on the potential synergistic effect of laser biomodulation when combined with modern bioceramics in VPT. The results could contribute to optimizing clinical protocols for managing irreversible pulpitis, shifting the paradigm towards more conservative, pulp-preserving treatments that enhance postoperative patient comfort.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
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.
TREATMENT
TRIPLE
Study Groups
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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.
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.
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.
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.
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.
Interventions
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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.
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.
Eligibility Criteria
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Inclusion Criteria
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
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).
9 Years
14 Years
ALL
No
Sponsors
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University of Fujairah
OTHER
Responsible Party
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Principal Investigators
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Mohamed Medhat Kataia, PhD
Role: PRINCIPAL_INVESTIGATOR
Fujairah University
Locations
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Dental Clinic, College of Dentistry, Fujairah University
Fujairah, Emirate of Fujairah, United Arab Emirates
Countries
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Central Contacts
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Facility Contacts
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Nabeel Ayappali Kalluvalappil, MDS
Role: primary
References
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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.
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.
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.
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.
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.
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.
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.
Rebel, H-H. (1922). "über die Ausheilung der freigelegten pulpa". Ditsch Zahnheilkd.
Other Identifiers
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UOF REC2025-04-22
Identifier Type: -
Identifier Source: org_study_id