Clinical and Radiographic Assessment of Photobiomodulated MTA Pulpotomy in Immature First Permanent Molars with Irreversible Pulpitis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: MTA Pulpotomy without photobiomodulation, MTA Pulpotomy with Photobiomodulation (LLLT).
- Who it may be relevant to
- Registry conditions: Dental Caries, Irreversible Pulpitis. Basic parameters: 6 years — 9 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Egypt
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Clinical and Radiographic Assessment of Photobiomodulated MTA Pulpotomy in Immature First Permanent Molars with Irreversible Pulpitis: a Randomized Controlled Clinical Trial
Overview
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.
Interventions
- Procedure MTA 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. - Procedure MTA 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.
Primary outcome measures
- Clinical Success of Pulpotomy Treatment [Time frame: 15 months post-treatment (assessed at 3, 6, 12, and 15 months).]
Secondary outcome measures (2)
- Radiographic Healing [Time frame: 15 months post-treatment (assessed at 6, 12, and 15 months).]
- Root Development Progression [Time frame: 15 months post-treatment (assessed at 6, 12, and 15 months)]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Egypt · 1 center
- Faculty of Dentistry — Al Mansurah
Identifiers
NCT: NCT06730360 · A0109024PP