Post-extraction Pain (PEP), Wound Healing
Conditions
Keywords
wound healing, photobiomodulation, post-extraction pain (PEP)
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.
Interventions
DEVICELow Level Laser Therapy
low-level laser therapy (LLLT) at a wavelength of 660nm (SiroLaser Blue, Dentsply Sirona, USA) after extraction
BEHAVIORALPlacebo plus Treatment As Usual
placebo (Sham) with only the aiming beam of thelow-level laser therapy (LLLT)
Sponsors
Alexandria University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
5 Years to 8 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Egypt
Outcome results
None listed