Effect of Low-Level Laser Therapy on Wound Healing and Post-extraction Pain Management of Primary Molars.
Effect of Low-Level Laser Therapy on Wound Healing and Post-extraction Pain Management of Primary Molars. (a Randomized Controlled Clinical Trial)
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
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Alexandria, Egypt, 5310002
- Faculty of Dentistry-Alexandria University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: intervention
intervention arm using low-level laser therapy photobiomodulation
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low-level laser therapy (LLLT) at a wavelength of 660nm (SiroLaser Blue, Dentsply Sirona, USA) after extraction
|
|
Placebo Comparator: placebo (Sham)
sham (placebo) arm
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placebo (Sham) with only the aiming beam of thelow-level laser therapy (LLLT)
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
wound healing
Time Frame: 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.
|
days 3 and 7
|
|
post-extraction pain (PEP)
Time Frame: 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.
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days 3 and 7
|
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wound size measurements
Time Frame: days 3 and 7
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wound size measurments immediately after the extraction, and at days 3 and using Image J software
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days 3 and 7
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1002-11/2024
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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