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

NCT07704463 | Completed

• 1 other identifier: 0834-01/2024
• Study Type: interventional
• Target: 57
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Symptomatic Irreversible Pulpitis (SIP)

Outcome Measures

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.

  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).

  12 months

Study Arms (3)

Control group MTA pulpotomy

ACTIVE COMPARATOR

The remaining pulp will be capped with MTA.

Other: Conventional MTA pulpotomy (control group)

Test group 660 nm laser + MTA pulpotomy

EXPERIMENTAL

Application of 660 nm diode laser and the remaining pulp will be capped with MTA.

Other: Application of 660 nm diode laser

Test group 970 nm laser +MTA pulpotomy

EXPERIMENTAL

Application of 970 nm diode laser and the remaining pulp will be capped with MTA.

Other: Application of 970 nm diode laser + MTA

Interventions

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

Test group 660 nm laser + MTA pulpotomy

Application of 970 nm diode laser + MTA OTHER

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

Test group 970 nm laser +MTA pulpotomy

Conventional MTA pulpotomy (control group) OTHER

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

Control group MTA pulpotomy

Eligibility Criteria

• Age: 6 Years - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Alexandria University: lead

Study Sites (1)

Faculty of Dentistry

Alexandria, Egypt

Location

MeSH Terms

Interventions

Lasers, Semiconductor; Pemetrexed; Control Groups

Intervention Hierarchy (Ancestors)

Lasers; Optical Devices; Equipment and Supplies; Radiation Equipment and Supplies; Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Dicarboxylic; Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 7, 2026
• First Posted: July 15, 2026
• Study Start: January 1, 2025
• Primary Completion: March 1, 2026
• Study Completion: April 1, 2026
• Last Updated: July 15, 2026

Record last verified: 2025-03

Locations

EG (1)