Actively Recruiting
Evaluation Of Laser Versus Conventional Pulpotomies In Mature Molar Teeth With Irreversible Pulpitis A Randomized Controlled Clinical Trial
Led by Rana Hegaz · Updated on 2025-12-17
60
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
R
Rana Hegaz
Lead Sponsor
A
Alexandria University
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the outcomes of laser-assisted pulpotomy compared to conventional pulpotomy in mature permanent molar teeth affected by symptomatic irreversible pulpitis. This randomized controlled clinical trial aims to assess healing progress and changes in radicular pulp volume using cone-beam computed tomography (CBCT) combined with artificial intelligence (AI) for automated segmentation. The study involves 60 mature teeth with irreversible pulpitis, focusing on clinical and radiographic healing over one year. Participants' teeth will be randomly assigned to one of three groups: photobiomodulation pulpotomy, photocoagulation pulpotomy, or conventional pulpotomy as the control. All groups will receive a bioceramic putty capping material after treatment. The laser treatments use a diode laser device that targets tissue precisely, while conventional pulpotomy uses sodium hypochlorite solution as a disinfectant. Follow-up visits include pain assessments, clinical exams, and radiographic evaluations at multiple intervals up to 12 months. During the study, post-operative pain will be measured at 24, 48, and 72 hours, and after one week using a numerical rating scale. Clinical and radiographic healing will be monitored at one, three, six, and twelve months. CBCT scans performed immediately after treatment and at the end of the follow-up will evaluate dentin bridge formation and radicular pulp changes using AI-based segmentation. The primary outcomes focus on healing progress, dentin bridge formation, and pulp volume changes over one year.
CONDITIONS
Brief Title
Evaluation Of Laser Versus Conventional Pulpotomies In Mature Molar Teeth With Irreversible Pulpitis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Permanent molar teeth with symptomatic irreversible pulpitis
- Patients aged 16 to 50 years
- Teeth must respond positively to cold testing and have clinical diagnosis of symptomatic irreversible pulpitis with or without periapical rarefaction
- Teeth selected must be restorable
- Patients must be medically healthy and free from systemic diseases (ASA I, II)
- Patients must agree to attend control visits
- Teeth with periapical index score (PAI) 1 or 2 will be selected
You will not qualify if you...
- Teeth with necrotic pulp, resorption, or subgingival caries
- Teeth with open apices
- Medically compromised patients
- Pregnant patients
- Patients with uncontrollable bleeding from the radicular pulp
- Teeth with periapical index score (PAI) 3 to 5
AI-Screening
AI-Powered Screening
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 - Single procedure with immediate post-operative period
Participants receive one of three types of pulpotomy procedures on mature molar teeth with irreversible pulpitis, capped with bioceramic putty material.
1 treatment visit (in-person)
Duration - 1 week
Participants are assessed for pain using a numerical rating scale at 24, 48, and 72 hours, and at one week after treatment.
4 visits (in-person) within the first week
Duration - 12 months
Participants undergo clinical and radiographic assessments including periapical radiographs at 1, 3, 6, and 12 months to evaluate healing progress. CBCT scans are done immediately after treatment and at 12 months to assess dentin bridge formation and radicular pulp changes.
5 visits (in-person) over 12 months
Trial Site Locations
Total: 1 location
1
Faculty of Dentistry
Alexandria, Egypt, 21527
Actively Recruiting
Research Team
R
Rana Mahmoud Hegazi, Assistant lecturer
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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