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

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

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.

Study Overview

• Status: Completed
• Conditions: Symptomatic Irreversible Pulpitis (SIP)
• Intervention / Treatment: Other: Conventional MTA pulpotomy (control group); Other: Application of 660 nm diode laser; Other: Application of 970 nm diode laser + MTA

• Study Type: Interventional
• Enrollment (Actual): 57
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Alexandria, Egypt
    • Faculty of Dentistry

Participation Criteria

Eligibility Criteria

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

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control group MTA pulpotomy; The remaining pulp will be capped with MTA.	Other: Conventional MTA pulpotomy (control group); The remaining pulp will be capped with MTA after final rinsing with saline
Experimental: Test group 660 nm laser + MTA pulpotomy; Application of 660 nm diode laser and the remaining pulp will be capped with MTA.	Other: Application of 660 nm diode laser; photobiomodulation (PBM) uses low-power irradiation from lasers or light-emitting diode (LED) devices to irradiate human tissues to stimulate dental pulp cells
Experimental: Test group 970 nm laser +MTA pulpotomy; Application of 970 nm diode laser and the remaining pulp will be capped with MTA.	Other: Application of 970 nm diode laser + MTA; Laser application with 970 nm wavelength to penetrate and affect pulpal cells

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
to assess the clinical and radiographic success rate of Laser pulpotomy procedure done in immature permanent molars with symptoms indicative of irreversible pulpitis.	12 months

Secondary Outcome Measures

Outcome Measure	Time Frame
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).	12 months

Collaborators and Investigators

• Sponsor: Alexandria University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2025
• Primary Completion (Actual): March 1, 2026
• Study Completion (Actual): April 1, 2026

Study Registration Dates

• First Submitted: July 7, 2026
• First Submitted That Met QC Criteria: July 14, 2026
• First Posted (Actual): July 15, 2026

Study Record Updates

• Last Update Posted (Actual): July 15, 2026
• Last Update Submitted That Met QC Criteria: July 14, 2026
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Amino Acids, Peptides, and Proteins; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Investigative Techniques; Epidemiologic Research Design; Epidemiologic Methods; Research Design; Methods; Equipment and Supplies; Lasers; Optical Devices; Radiation Equipment and Supplies; Guanine; Hypoxanthines; Purinones; Purines; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Dicarboxylic; Pemetrexed; Control Groups; Lasers, Semiconductor
• Other Study ID Numbers: 0834-01/2024

Drug and device information, study documents

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