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

Not Applicable

Recruiting

• Conditions: Post-extraction Pain (PEP); Wound Healing

• Registration Number: NCT07033403
• Lead Sponsor: Alexandria University

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.

Study Timeline

• Status Verified: 2025-06
• Study Start: 2025-06-01
• Study First Submitted: 2025-06-03
• Study First Submitted QC: 2025-06-13
• Last Update Submitted: 2025-06-13
• Study First Posted: 2025-06-24
• Last Update Posted: 2025-06-24
• Primary Completion: 2025-08-01
• Study Completion: 2025-10-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 18

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
wound healing	days 3 and 7	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.
post-extraction pain (PEP)	days 3 and 7	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.
wound size measurements	days 3 and 7	wound size measurments immediately after the extraction, and at days 3 and using Image J software

Trial Locations

Locations (1)

Faculty of Dentistry-Alexandria University; 🇪🇬 Alexandria, Egypt