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Evaluation Of Laser Versus Conventional Pulpotomies In Mature Molar Teeth With Irreversible Pulpitis

Evaluation Of Laser Versus Conventional Pulpotomies In Mature Molar Teeth With Irreversible Pulpitis (A Randomized Controlled Clinical Trial)

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07287709
Enrollment
60
Registered
2025-12-17
Start date
2025-11-07
Completion date
2026-05-31
Last updated
2025-12-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Irreversible Pulpitis (Toothache)

Keywords

Photobiomodulation,, photocoagulation,, pulpotomy,, segmentation,, irreversible pulpitis, artificial intelligence, bioceramic putty

Brief summary

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

DEVICEDiode laser

a contact-type laser, it selectively and precisely affects only the tissues directly beneath it, thereby preserving the surrounding radicular tissue

A disinfecting agent used in conventional pulpotomy procedures

Sponsors

Alexandria University
CollaboratorOTHER
Rana Hegaz
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
16 Years to 50 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Radiographic assessment of the dentin bridge formationone yearevaluating the dentin bridge formation using periapical radiographs and CBCT
Automated segmentation of the radicular pulp spaceone yearthis will be done using CBCT imaging
Assessment of healing progressone yearevaluating clinically the signs and symptoms of pain and it will be recorded as yes and no question. \-

Countries

Egypt

Contacts

Primary ContactRana Mahmoud Hegazi, Assistant lecturer
ranahegazi1991@gmail.com01094428209

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026