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

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

• 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