Actively Recruiting
Clinical and Radiographic Assessment of Photobiomodulated MTA Pulpotomy in Immature First Permanent Molars with Irreversible Pulpitis: a Randomized Controlled Clinical Trial
Led by Mansoura University · Updated on 2024-12-17
72
Participants Needed
1
Research Sites
13 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effectiveness of photobiomodulation (PBM), also known as low-level laser therapy, combined with mineral trioxide aggregate (MTA) pulpotomy for treating irreversible pulpitis in immature first permanent molars of children aged 6 to 9 years. The study compares this combined therapy to MTA pulpotomy alone to see if PBM can enhance healing, reduce inflammation, and manage pain better. This randomized clinical trial includes 72 children divided into two groups to assess clinical and radiographic outcomes over 15 months. Participants are assigned to one of two groups: one group receives the standard MTA pulpotomy without photobiomodulation, while the other group receives MTA pulpotomy enhanced with PBM applied to the pulp stumps before placing MTA. PBM uses specific light wavelengths to stimulate pulp regeneration and reduce inflammation. Follow-up visits are scheduled at 3, 6, 12, and 15 months to monitor treatment success and healing progression. During the study, children will undergo clinical exams to check for symptoms such as pain or tenderness, and radiographic imaging to evaluate pulp healing and root development. Researchers will assess the success of the pulpotomy treatment primarily by the absence of clinical symptoms at various intervals. The study also tracks radiographic healing and root growth over 15 months to understand the long-term effects of adding PBM to MTA pulpotomy.
CONDITIONS
Brief Title
Clinical and Radiographic Assessment of Photobiomodulated MTA Pulpotomy in Immature First Permanent Molars with Irreversible Pulpitis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Children aged 6 to 9 years
- Non-contributory medical history (healthy otherwise)
- Presence of carious first permanent molars with deep caries extending to at least two-thirds 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
You will not qualify if you...
- 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
AI-Screening
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Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day
Participants undergo MTA pulpotomy treatment, either with or without photobiomodulation (low-level laser therapy) to preserve pulp vitality in immature first permanent molars with irreversible pulpitis.
1 treatment visit (in-person)
Duration - 15 months
Participants are monitored to assess clinical success and radiographic healing after treatment, including evaluation of pain, tenderness, and pulp healing.
Follow-up visits at 3, 6, 12, and 15 months post-treatment
Trial Site Locations
Total: 1 location
1
Faculty of Dentistry
Al Mansurah, Dakahlia Governorate, Egypt, 35516
Actively Recruiting
Research Team
P
peter samir abdelshahed, assistant lecture
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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