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)

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).

Study Overview

• Status: Recruiting
• Conditions: Irreversible Pulpitis (Toothache)
• Intervention / Treatment: Device: Diode laser; Other: Sodium Hypochlorite Solution

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.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Rana Mahmoud Hegazi, Assistant lecturer; Phone Number: 01094428209; Email: ranahegazi1991@gmail.com

Study Locations

• Egypt
  • Alexandria, Egypt, 21527
    • Recruiting
    • Faculty of Dentistry
    • Contact: Rana Mahmoud Hegazi, Assistant lecturer; Phone Number: 01094428209; Email: ranahegazi1991@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group A Photo-biomodulation pulpotomy with Bioceramic putty	Device: Diode laser; a contact-type laser, it selectively and precisely affects only the tissues directly beneath it, thereby preserving the surrounding radicular tissue
Experimental: Group B photocoagulation pulpotomy with Bioceramic putty	Device: Diode laser; a contact-type laser, it selectively and precisely affects only the tissues directly beneath it, thereby preserving the surrounding radicular tissue
Active Comparator: Group C(Control) Conventional pulpotomy with Bioceramic putty	Other: Sodium Hypochlorite Solution; A disinfecting agent used in conventional pulpotomy procedures

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Rana Hegaz
• Collaborators: Alexandria University
• Investigators: Principal Investigator: 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.

Study record dates

Study Major Dates

• Study Start (Actual): November 7, 2025
• Primary Completion (Estimated): May 1, 2026
• Study Completion (Estimated): May 1, 2026

Study Registration Dates

• First Submitted: November 23, 2025
• First Submitted That Met QC Criteria: December 3, 2025
• First Posted (Actual): December 17, 2025

Study Record Updates

• Last Update Posted (Actual): December 17, 2025
• Last Update Submitted That Met QC Criteria: December 3, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: artificial intelligence; irreversible pulpitis; Photobiomodulation,; photocoagulation,; pulpotomy,; segmentation,; bioceramic putty
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Stomatognathic Diseases; Tooth Diseases; Facial Pain; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Toothache; Equipment and Supplies; Lasers; Optical Devices; Radiation Equipment and Supplies; Inorganic Chemicals; Chlorine Compounds; Oxides; Oxygen Compounds; Hypochlorous Acid; Sodium Compounds; Sodium Hypochlorite; Lasers, Semiconductor
• Other Study ID Numbers: 9258137

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No