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

Alexandria University

Status: Enrolling

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

Treatments: Device: Low Level Laser Therapy; Behavioral: Placebo plus Treatment As Usual

Study type: Interventional

Funder types: Other

Identifiers

NCT07033403

1002-11/2024

Details and patient eligibility

About

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

Full 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.

Enrollment: 18 estimated patients

Sex: All

Ages: 5 to 8 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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18 participants in 2 patient groups, including a placebo group

intervention

Experimental group

Description:

intervention arm using low-level laser therapy photobiomodulation

Treatment:

Device: Low Level Laser Therapy

placebo (Sham)

Placebo Comparator group

Description:

sham (placebo) arm

Treatment:

Behavioral: Placebo plus Treatment As Usual