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

Last updated: December 12, 2024
Sponsor: Mansoura University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Acute And Chronic Dental Pain

Treatment

MTA Pulpotomy with Photobiomodulation (LLLT)

MTA Pulpotomy without photobiomodulation

Clinical Study ID

NCT06730360
A0109024PP
  • Ages 6-9
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 withoutperiapical periodontitis.

  • Restorable tooth.

  • Probing pocket depth and mobility within normal limits.

  • No signs of pulpal necrosis, including sinus tract or swelling.

Exclusion

Exclusion Criteria:

  • Insufficient bleeding after pulp exposure (indicating necrotic or partially necroticpulp).

  • 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 orswelling.

Study Design

Total Participants: 72
Treatment Group(s): 2
Primary Treatment: MTA Pulpotomy with Photobiomodulation (LLLT)
Phase:
Study Start date:
October 10, 2024
Estimated Completion Date:
April 05, 2026

Study 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.

Connect with a study center

  • Faculty of Dentistry

    Mansoura, Dakahlia 35516
    Egypt

    Active - Recruiting

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