Clinical and Radiographic Assessment of Photobiomodulated MTA Pulpotomy in Immature First Permanent Molars with Irreversible Pulpitis

Not Applicable

Recruiting

• Conditions: Dental Caries; Irreversible Pulpitis

• Registration Number: NCT06730360
• Lead Sponsor: Mansoura University

Brief Summary

This study evaluates the effectiveness of photobiomodulation (PBM) in conjunction with mineral trioxide aggregate (MTA) pulpotomy for treating irreversible pulpitis in immature first permanent molars. PBM, also known as low-level laser therapy (LLLT), is used to enhance healing, reduce inflammation, and manage pain in young teeth. The randomized clinical trial involves 72 children aged 6-9 years, divided into two groups: one receiving MTA pulpotomy alone and the other receiving MTA pulpotomy with PBM. Clinical and radiographic outcomes will be assessed at intervals over 15 months. This research aims to determine the combined therapy's efficacy in improving pulp healing and reducing post-operative discomfort compared to MTA alone.

Detailed Description

This randomized controlled trial evaluates the clinical and radiographic outcomes of MTA pulpotomy, with and without PBM, for immature permanent molars diagnosed with irreversible pulpitis. The study includes two parallel groups of 36 children each. Group I will undergo MTA pulpotomy alone, while Group II will receive PBM treatment alongside MTA pulpotomy.

PBM employs low-level laser therapy to stimulate pulp tissue regeneration, enhance mitochondrial activity, and reduce inflammation and pain, thereby potentially improving MTA pulpotomy outcomes. Key inclusion criteria involve children with deep carious lesions and clinical signs of irreversible pulpitis but without pulpal necrosis. Follow-up will occur at 3, 6, 12, and 15 months post-treatment to evaluate success based on the absence of clinical symptoms (e.g., pain, tenderness) and radiographic indicators of healing.

By comparing these two approaches, the study aims to provide insights into PBM's role as an adjunctive therapy for vital pulp preservation, particularly in pediatric dentistry.

Study Timeline

• Status Verified: 2024-09
• Study Start: 2024-10-10
• Study First Submitted: 2024-12-09
• Study First Submitted QC: 2024-12-09
• Study First Posted: 2024-12-12
• Last Update Submitted: 2024-12-12
• Last Update Posted: 2024-12-17
• Primary Completion: 2026-01-01
• Study Completion: 2026-04-05

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 72

Inclusion Criteria

• Children aged 6 to 9 years.
• Non-contributory medical history (healthy otherwise).
• Presence of carious first permanent molars with the following characteristics:
• Deep caries extending to ≥2/3 of dentin.
• Positive response to cold testing.
• Clinical diagnosis of irreversible pulpitis (moderate or severe), with or without periapical periodontitis.
• Restorable tooth.
• Probing pocket depth and mobility within normal limits.
• No signs of pulpal necrosis, including sinus tract or swelling.

Exclusion Criteria

• Insufficient bleeding after pulp exposure (indicating necrotic or partially necrotic pulp).
• Presence of systemic or medical conditions that may contraindicate participation.
• Teeth with unrestorable structure.
• Teeth showing signs of pulpal necrosis, such as the presence of a sinus tract or swelling.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Clinical Success of Pulpotomy Treatment	15 months post-treatment (assessed at 3, 6, 12, and 15 months).	Evaluation of clinical signs and symptoms (absence of pain, tenderness to percussion, sinus tract, or swelling). Treatment is considered successful if these are absent at all follow-up visits.

Secondary Outcome Measures

Name	Time	Method
Radiographic Healing	15 months post-treatment (assessed at 6, 12, and 15 months).	Assessment of radiographic evidence of healing, including no periapical rarefaction, root resorption, or new furcal pathosis. Success is determined by achieving a PAI (Periapical Index) score of 1 or 2, or reduction in PAI score if preoperative rarefaction is present.; Periapical Index (PAI) Scale: 1 to 5; Interpretation: 1: Normal periapical structures (better outcome) 5: Severe changes with evident bone destruction (worse outcome).
Root Development Progression	15 months post-treatment (assessed at 6, 12, and 15 months)	Radiographic evaluation of root maturity and the formation of a hard tissue bridge

Trial Locations

Locations (1)

Faculty of Dentistry; 🇪🇬 Mansoura, Dakahlia, Egypt