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