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

NCT07033403 | Completed

• 1 other identifier: 1002-11/2024
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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

Conditions

Post-extraction Pain (PEP); Wound Healing

Keywords

wound healing; photobiomodulation; post-extraction pain (PEP)

Outcome Measures

Primary Outcomes (3)

• wound healing

  wound healing will be measured using using the Landry, Turnbull and Howley wound healing index , with minimum score 1 and maximum score 5 , as the score inceases this means better healing.

  days 3 and 7

• post-extraction pain (PEP)

  post- extraction pain will be measured using the Arabic Version of a self-reported Questionnaire Assessing Pain, Discomfort and Related Jaw Function Impairment in Children on the night of extraction and on day 7 using WONG-BAKER FACES pain scale with 0 minimum and 10 maximum value. the higher the value the worse the outcome.

  days 3 and 7

• wound size measurements

  wound size measurments immediately after the extraction, and at days 3 and using Image J software

  days 3 and 7

Study Arms (2)

intervention

EXPERIMENTAL

intervention arm using low-level laser therapy photobiomodulation

Device: Low Level Laser Therapy

placebo (Sham)

PLACEBO COMPARATOR

sham (placebo) arm

Behavioral: Placebo plus Treatment As Usual

Interventions

Low Level Laser Therapy DEVICE

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

intervention

Placebo plus Treatment As Usual BEHAVIORAL

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

placebo (Sham)

Eligibility Criteria

• Age: 5 Years - 8 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Alexandria University: lead

Study Sites (1)

Faculty of Dentistry-Alexandria University

Alexandria, 5310002, Egypt

Location

MeSH Terms

Interventions

Low-Level Light Therapy; Therapeutics

Intervention Hierarchy (Ancestors)

Laser Therapy; Phototherapy

Study Design

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

Study Record Dates

• First Submitted: June 3, 2025
• First Posted: June 24, 2025
• Study Start: June 1, 2025
• Primary Completion: November 1, 2025
• Study Completion: November 15, 2025
• Last Updated: December 2, 2025

Record last verified: 2025-06

Locations

EG (1)