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

NCT07287709 | Recruiting DMC

• 1 other identifier: 9258137
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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).

Conditions

Irreversible Pulpitis (Toothache)

Keywords

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

Outcome Measures

Primary Outcomes (3)

• Assessment of healing progress

  evaluating clinically the signs and symptoms of pain and it will be recorded as yes and no question. \-

  one year

• Radiographic assessment of the dentin bridge formation

  evaluating the dentin bridge formation using periapical radiographs and CBCT

  one year

• Automated segmentation of the radicular pulp space

  this will be done using CBCT imaging

  one year

Study Arms (3)

Group A Photo-biomodulation pulpotomy with Bioceramic putty

EXPERIMENTAL

Device: Diode laser

Group B photocoagulation pulpotomy with Bioceramic putty

EXPERIMENTAL

Device: Diode laser

Group C(Control) Conventional pulpotomy with Bioceramic putty

ACTIVE COMPARATOR

Other: Sodium Hypochlorite Solution

Interventions

Diode laser DEVICE

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

Group A Photo-biomodulation pulpotomy with Bioceramic putty; Group B photocoagulation pulpotomy with Bioceramic putty

Sodium Hypochlorite Solution OTHER

A disinfecting agent used in conventional pulpotomy procedures

Group C(Control) Conventional pulpotomy with Bioceramic putty

Eligibility Criteria

• Age: 16 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Rana Hegaz: lead
• Alexandria University: collaborator

Study Sites (1)

Faculty of Dentistry

Alexandria, 21527, Egypt

RECRUITING

MeSH Terms

Conditions

Toothache

Interventions

Lasers, Semiconductor; Sodium Hypochlorite

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases; Facial Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Lasers; Optical Devices; Equipment and Supplies; Radiation Equipment and Supplies; Hypochlorous Acid; Chlorine Compounds; Inorganic Chemicals; Oxides; Oxygen Compounds; Sodium Compounds

Study Officials

• Rania Noaman ELbackly, Professor

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rana Mahmoud Hegazi, Assistant lecturer

CONTACT

01094428209; ranahegazi1991@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant lecturer ,Endodontics, Department of Conservative Dentistry, Faculty of Dentistry, Alexandria University, Alexandria, Egypt.

Study Record Dates

• First Submitted: November 23, 2025
• First Posted: December 17, 2025
• Study Start: November 7, 2025
• Primary Completion: May 1, 2026
• Study Completion: May 1, 2026
• Last Updated: December 17, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)