RecruitingNot ApplicableNCT06730360

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

Clinical and Radiographic Assessment of Photobiomodulated MTA Pulpotomy in Immature First Permanent Molars with Irreversible Pulpitis: a Randomized Controlled Clinical Trial


Sponsor

Mansoura University

Enrollment

72 participants

Start Date

Oct 10, 2024

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 6 YearsMax Age: 9 Years

Inclusion Criteria9

  • 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 Criteria4

  • 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.

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Interventions

PROCEDUREMTA Pulpotomy without photobiomodulation

This intervention involves the application of Mineral Trioxide Aggregate (MTA) to the pulp chamber after the removal of the coronal pulp tissue in first permanent molars with irreversible pulpitis. The procedure is performed without the use of photobiomodulation (low-level laser therapy). The MTA is placed as a seal to preserve the vitality of the remaining radicular pulp.

PROCEDUREMTA Pulpotomy with Photobiomodulation (LLLT)

This intervention combines MTA pulpotomy with photobiomodulation (low-level laser therapy). After performing the MTA pulpotomy, low-level laser therapy is applied to the pulp stumps to reduce inflammation, promote healing, and modulate pain. The laser therapy uses specific wavelengths of light to stimulate cellular activity and enhance the regeneration of pulp tissue.


Locations(1)

Faculty of Dentistry

Al Mansurah, Dakahlia Governorate, Egypt

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NCT06730360


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