Ignite Creation Date:
2025-12-25 @ 2:13 AM
Ignite Modification Date:
2025-12-27 @ 6:57 AM
Study NCT ID:
NCT06730360
Status:
RECRUITING
Last Update Posted:
2024-12-17
First Post:
2024-12-09
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical and Radiographic Assessment of Photobiomodulated MTA Pulpotomy in Immature First Permanent Molars with Irreversible Pulpitis
Sponsor:
Mansoura University
Organization:
Study Overview
Official Title:
Clinical and Radiographic Assessment of Photobiomodulated MTA Pulpotomy in Immature First Permanent Molars with Irreversible Pulpitis: a Randomized Controlled Clinical Trial
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: