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NCT Number: NCT07287709

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

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).

Recruiting

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Key information

Age range

16 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Dentistry

Alexandria, 21527, Egypt

Location status: Recruiting

Location contact

Rana Mahmoud Hegazi, Assistant lecturer

CONTACT

[email protected]

01094428209

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Diode laser

Device

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

Sodium Hypochlorite Solution

Other

A disinfecting agent used in conventional pulpotomy procedures

Primary outcomes

  1. Assessment of healing progress

    Time frame: one year

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

    -

  2. Radiographic assessment of the dentin bridge formation

    Time frame: one year

    evaluating the dentin bridge formation using periapical radiographs and CBCT

  3. Automated segmentation of the radicular pulp space

    Time frame: one year

    this will be done using CBCT imaging

Study contacts

Contact information is provided by the study sponsor or research team.

Rana Mahmoud Hegazi, Assistant lecturer

CONTACT

[email protected]

01094428209

Sponsors and collaborators

Lead sponsor

Rana Hegaz

Other

Collaborators

  • Alexandria University

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Dec 17, 2025
Registry last updated
Dec 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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