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

NCT ID: NCT07287709

Last Updated: 2025-12-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-11-07

Study Completion Date

2026-05-31

Brief Summary

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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

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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.

Conditions

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Irreversible Pulpitis (Toothache)

Keywords

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Group A Photo-biomodulation pulpotomy with Bioceramic putty

Group Type EXPERIMENTAL

Diode laser

Intervention Type DEVICE

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

Group B photocoagulation pulpotomy with Bioceramic putty

Group Type EXPERIMENTAL

Diode laser

Intervention Type DEVICE

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

Group C(Control) Conventional pulpotomy with Bioceramic putty

Group Type ACTIVE_COMPARATOR

Sodium Hypochlorite Solution

Intervention Type OTHER

A disinfecting agent used in conventional pulpotomy procedures

Interventions

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Diode laser

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

Intervention Type DEVICE

Sodium Hypochlorite Solution

A disinfecting agent used in conventional pulpotomy procedures

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

16 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Alexandria University

OTHER

Sponsor Role collaborator

Rana Hegaz

OTHER

Sponsor Role lead

Responsible Party

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Rana Hegaz

Assistant lecturer ,Endodontics, Department of Conservative Dentistry, Faculty of Dentistry, Alexandria University, Alexandria, Egypt.

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Rania Noaman ELbackly, Professor

Role: PRINCIPAL_INVESTIGATOR

Endodontics, Conservative Dentistry Department, Faculty of Dentistry, Alexandria University, Alexandria, Egypt. Tissue Engineering Laboratories, Faculty of Dentistry, Alexandria University, Alexandria, Egypt.

Locations

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Faculty of Dentistry

Alexandria, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Rana Mahmoud Hegazi, Assistant lecturer

Role: CONTACT

Phone: 01094428209

Email: [email protected]

Facility Contacts

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Rana Mahmoud Hegazi, Assistant lecturer

Role: primary

Other Identifiers

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9258137

Identifier Type: -

Identifier Source: org_study_id