Evaluation Of Laser Versus Conventional Pulpotomies In Mature Molar Teeth 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: Diode laser, Sodium Hypochlorite Solution.
- Who it may be relevant to
- Registry conditions: Irreversible Pulpitis (Toothache). Basic parameters: 16 years — 50 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
Evaluation Of Laser Versus Conventional Pulpotomies In Mature Molar Teeth With Irreversible Pulpitis (A Randomized Controlled Clinical Trial)
Overview
this clinical trial is evaluating the outcome of laser assisted pulpotomy compared to conventional pulpotomy in mature teeth with symptomatic irreversible pulpitis (SIP) assessed by CBCT followed by automated segmentation using Artificial intelligence (AI).
Detailed description
Sixty human permanent molar teeth having irreversible pulpitis will be selected. Teeth will be randomly divided into 3 groups according to the type of pulpotomy; Group A: Photobiomodulation (PBM) pulpotomy, Group B: photocoagulation pulpotomy and Group C: Conventional pulpotomy which will serve as control. All 3 groups will be capped with bioceramic putty material. Post operative pain will be assessed at 24, 48 and 72 hours then after one week using numerical rating scale (NRS). Clinical and radiographic assessment using periapical radiograph of the healing progress will be done simultaneously during the follow up at one, three, six and 12 months intervals. CBCT will be done immediate postoperative and at the end of the follow up period to assess the dentin bridge formation and for automated segmentation to assess the radicular pulp volume changes.
Interventions
- Device Diode laser
a contact-type laser, it selectively and precisely affects only the tissues directly beneath it, thereby preserving the surrounding radicular tissue - Other Sodium Hypochlorite Solution
A disinfecting agent used in conventional pulpotomy procedures
Primary outcome measures
- Assessment of healing progress [Time frame: one year]
- Radiographic assessment of the dentin bridge formation [Time frame: one year]
- Automated segmentation of the radicular pulp space [Time frame: one year]
Eligibility criteria
Inclusion criteria
- Permanent molar teeth with symptomatic irreversible pulpitis.
- The patient should be ≥ 16 to 50 years old.
- Teeth should give positive response to cold testing and clinical diagnosis of SIP with or without periapical rarefaction.
- Teeth will be selected only if they are restorable.
- Patient medically healthy and free from systemic diseases. ASA I, II.
- patients who agreed to participate in the study to attend the control visits.
- Teeth with periapical index score (PAI) 1 and 2 will be selected
Exclusion criteria
- 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.
- Patients with (PAI) score 3-5 will be excluded from the study
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
- Double blind
- Primary purpose
- Treatment
Study locations
Egypt · 1 center
- Faculty of Dentistry — Alexandria
Identifiers
NCT: NCT07287709 · 9258137