Effect of Low-Level Laser Therapy on Wound Healing and Post-extraction Pain Management of Primary Molars.

NCT ID: NCT07033403

Last Updated: 2025-12-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-06-01
• Study Completion Date: 2025-11-15

Brief Summary

The goal of this clinical trial is to evaluate the effect of low-level laser therapy on wound healing of primary molar teeth extraction. in children aged 5-8 years with bilateral primary molars indicated for extraction. The main questions it aims to answer are:

• does low-level laser therapy affect wound healing of primary molar teeth extraction?
• does of low-level laser therapy affect post-extraction pain management of primary molar.? Researchers will compare placebo group (Sham side) to Intervention side ( split mouth design).

Participants will be subjected to low level laser and post-extraction instructions in the intervention side, while the placebo side will receive post-extraction instructions only, participants will come for follow up on days 3, and 7 after extraction, they will answer self-reported questionnare related to post-extraction pain , wound healing will also be measured from photographs of the extraction site using Image J soft-ware

Detailed Description

The goal of this clinical trial is to evaluate the effect of low-level laser therapy on wound healing of primary molar teeth extraction. in children aged 5-8 years with bilateral primary molars indicated for extraction. this is a split mouth randomized controlled clinical trial.

Each participant will have one side randomly assigned to intervention using low level diode laser at a wavelength of 660nm aimed at the extraction site 1 cm away for 60 seconds in continuous emission mode. the other side will be placebo side with just the aiming beam, in both visits the participant will be given post-extraction instructions

participants will come for follow up on days 3, and 7 after extraction, they will answer an arabic self-reported questionnaire comprising 33 items that assessed pain, discomfort, analgesic consumption, daily activities, and jaw-function impairment on the night of the extraction and after 7 days, wound healing will also be measured days 3 and 7 using of the extraction site using Wound healing index by Landry, Turnbull and Howley, and wound size will be measured using Image J soft-ware from the from photographs.

Conditions

Post-extraction Pain (PEP); Wound Healing

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

intervention

intervention arm using low-level laser therapy photobiomodulation

Group Type: EXPERIMENTAL

Low Level Laser Therapy

Intervention Type: DEVICE

low-level laser therapy (LLLT) at a wavelength of 660nm (SiroLaser Blue, Dentsply Sirona, USA) after extraction

placebo (Sham)

sham (placebo) arm

Group Type: PLACEBO_COMPARATOR

Placebo plus Treatment As Usual

Intervention Type: BEHAVIORAL

placebo (Sham) with only the aiming beam of thelow-level laser therapy (LLLT)

Interventions

Low Level Laser Therapy

low-level laser therapy (LLLT) at a wavelength of 660nm (SiroLaser Blue, Dentsply Sirona, USA) after extraction

Intervention Type: DEVICE

Placebo plus Treatment As Usual

placebo (Sham) with only the aiming beam of thelow-level laser therapy (LLLT)

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• • Age range from 5 - 8 years.

• Children free of any systemic disease or special health care need.
• No previous extractions.
• Positive or definitely positive behaviour during preoperative assessments according to the Frankl Rating Scale (score 3 or 4).
• Patients with bilateral primary molars indicated for extraction.
• Patients whose parents will give their written consent to participate

Exclusion Criteria

• Resorption more than one third of the root length.
• Signs of mobility.
• History of allergy to local anesthesia.
• Medical History involving conditions such as prolonged bleeding, platelet disorders, hypersensitivity, allergic reactions to pain relievers and contradictions to laser therapy.
• Acute pain.

• Minimum Eligible Age: 5 Years
• Maximum Eligible Age: 8 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Alexandria University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Faculty of Dentistry-Alexandria University

Alexandria, , Egypt

Countries

Egypt

Other Identifiers

1002-11/2024

Identifier Type: -

Identifier Source: org_study_id