Symptomatic Irreversible Pulpitis, Symptomatic Irreversible Pulpitis (SIP)
Conditions
Keywords
Vital Pulp Therapy, Pulpotomy, Irreversible Pulpitis, Postoperative Pain, Calcium Silicate Cement, Bioceramic, Laser Biomodulation, Er,Cr:YSGG Laser, EndoCem, Biodentine, Randomized Controlled Trial
Brief 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. 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.
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.
Interventions
DEVICECalcium 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.
DEVICEEr,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
University of Fujairah
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Masking description
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.
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
9 Years to 14 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative Pain Intensity as assessed by Visual Analogue Scale (VAS) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Success Rate | 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. |
| Radiographic Success Rate | 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. |
Countries
United Arab Emirates
Contacts
PRINCIPAL_INVESTIGATORMohamed Medhat Kataia, PhD
Fujairah University
Outcome results
None listed