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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:
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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| intervention | Experimental | intervention arm using low-level laser therapy photobiomodulation |
|
| placebo (Sham) | Placebo Comparator | sham (placebo) arm |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Low Level Laser Therapy | Device | low-level laser therapy (LLLT) at a wavelength of 660nm (SiroLaser Blue, Dentsply Sirona, USA) after extraction |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
• Age range from 5 - 8 years.
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of Dentistry-Alexandria University | Alexandria | 5310002 | Egypt |
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| ID | Term |
|---|---|
| D028022 | Low-Level Light Therapy |
| D013812 | Therapeutics |
| ID | Term |
|---|---|
| D053685 | Laser Therapy |
| D010789 | Phototherapy |
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| Placebo plus Treatment As Usual | Behavioral | placebo (Sham) with only the aiming beam of thelow-level laser therapy (LLLT) |
|