Symptomatic Irreversible PulpitisNCT07290049
Postoperative Pain After Pulpotomy in Children Using Calcium Silicate Cements With and Without Laser Therapy
A study testing Calcium Silicate Cement and Er,Cr:YSGG Laser in people with Symptomatic Irreversible Pulpitis and Symptomatic Irreversible Pulpitis (SIP), run by University of Fujairah at 1 site in United Arab Emirates.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 9 to 14 years
- Conditions the study is for
- Symptomatic Irreversible Pulpitis, Symptomatic Irreversible Pulpitis (SIP)
- What is being tested?
- Calcium Silicate Cement and Er,Cr:YSGG Laser
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteUnited Arab Emirates
- Study dates
- 24 Apr 2025to 25 Jun 2026
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 9 to 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United Arab Emirates1 site
Dental Clinic, College of Dentistry, Fujairah University
Fujairah, Emirate of Fujairah, 2202
About this study
Official title: 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.
Read the 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.
- Being tested
- Calcium Silicate Cement, Er,Cr:YSGG Laser
- Keywords
- Vital Pulp Therapy, Pulpotomy, Irreversible Pulpitis, Postoperative Pain, Calcium Silicate Cement, Bioceramic, Laser Biomodulation, Er,Cr:YSGG Laser, EndoCem, Biodentine, Randomized Controlled Trial
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Calcium Silicate CementDevice
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 LaserDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Calcium Silicate Cement; Device: Er,Cr:YSGG Laser |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At 6, 12, 24, and 48 hours after the completion of the pulpotomy procedure.
Secondary outcomes (2)
Clinical Success Rate
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.
Measured: At 1 week and 6 months post-treatment.
Radiographic Success Rate
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.
Measured: At 6 months post-treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2025
- Study start24 Apr 2025
- Primary completion25 Apr 2026
- Study completion25 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Symptomatic Irreversible PulpitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Fujairah
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mohamed Medhat Kataia, PhD, Principal investigator, Fujairah University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07290049
- Sponsor's protocol ID
- UOF REC2025-04-22
- Status last verified
- Jul 2026
- First submitted
- 4 Dec 2025
- Last updated
- 22 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 32342038Kim 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.
PubMed 25052144Kaur 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.
PubMed 28969295Drouri 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.
PubMed 37250608Stanley 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.
PubMed 2682429Caplan 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.
PubMed 15929546AAE 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.
PubMed 34352305Rebel, H-H. (1922). "über die Ausheilung der freigelegten pulpa". Ditsch Zahnheilkd.