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NCT Number: NCT07704463

Clinical and Radiographic Evaluation of Laser Assisted Pulpotomy in Immature Permanent Molars With Symptoms Indicative of Irreversible Pulpitis

The goal of this clinical trial is to assess the clinical and radiographic success rate of Laser pulpotomy procedure done in immature permanent molars with symptoms indicative of irreversible pulpitis.. The main question it aims to answer is:

whether the combined use of Laser pulpotomy with MTA capping material will provide faster healing with acceleration of complete root formation in immature permanent molars compared to MTA pulpotomy alone?

Participants will:

The coronal inflammed pulp will be carefully amputated to the level of the canal orifices.

Hemostasis will be achieved by gentle placement of a saline-moistened cotton pellet and Placement of capping material will be performed in the study groups.

The post-operative clinical follow up will be done after one week for patient reassurance. Then the postoperative clinical and radiographic follow-up will be scheduled up to twelve months.

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Key information

Conditions

Symptomatic Irreversible Pulpitis (SIP)

Age range

6 year–14 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Dentistry

Alexandria, Egypt

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Children with an age ranging between 6 to 14 years old with no gender predilection.
  • Children free of any systemic disease or special health care needs.
  • Patients complaining from intermittent or spontaneous, sharp, localized, diffuse, or referred pain.
  • Selected teeth should give long lasting positive responses to cold testing.
  • Soft tissues around the tooth are normal.
  • Periapical radiographs show deep carious lesions.
  • Patients with immature permanent molars (stages 8 and 9) according to Nolla's classification for tooth developmental stage.
  • Periapical index score 1 or 2.
  • Following pulpal amputation, hemostasis could be easily achievable within 5 to 10 minutes with a sterile moist cotton pellet.

Exclusion criteria

  • Child with bad experience of dental treatment (uncooperative patient).
  • Non-restorable teeth.
  • Negative response to cold testing.
  • Bleeding could not be controlled.
  • Absence of bleeding from any of the canals.
  • Pus discharge through an associated sinus tract.
  • Pulpal calcifications
  • Radiographic signs of internal or external resorption.

Treatment and study plan

Application of 660 nm diode laser

Other

photobiomodulation (PBM) uses low-power irradiation from lasers or light-emitting diode (LED) devices to irradiate human tissues to stimulate dental pulp cells

Application of 970 nm diode laser + MTA

Other

Laser application with 970 nm wavelength to penetrate and affect pulpal cells

Conventional MTA pulpotomy (control group)

Other

The remaining pulp will be capped with MTA after final rinsing with saline

Primary outcomes

  1. to assess the clinical and radiographic success rate of Laser pulpotomy procedure done in immature permanent molars with symptoms indicative of irreversible pulpitis.

    Time frame: 12 months

Secondary outcomes

  1. 1. Evaluation of laser effect on decreasing immediate postoperative pain using Numerical Rating Pain Scale with min (0) No pain - max (10) severe pain. 2. Evaluation of laser effect on dentin bridge formation (if it is radiographically present or not).

    Time frame: 12 months

Sponsors and collaborators

Lead sponsor

Alexandria University

Other

Registry information

Official study title

Clinical and Radiographic Evaluation of Laser Assisted Pulpotomy in Immature Permanent Molars With Symptoms Indicative of Irreversible Pulpitis (A Randomized Controlled Clinical Trial )

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jul 15, 2026
Registry last updated
Jul 15, 2026

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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