Photobiomodulation Effects on Pain, Edema, Paresthesia and Bone Regeneration After Maxillar Surgical Disjunction
Keywords
Abstract
Dates
Last Verified: | 12/31/2018 |
First Submitted: | 01/17/2019 |
Estimated Enrollment Submitted: | 01/21/2019 |
First Posted: | 01/23/2019 |
Last Update Submitted: | 01/21/2019 |
Last Update Posted: | 01/23/2019 |
Actual Study Start Date: | 01/01/2019 |
Estimated Primary Completion Date: | 01/29/2021 |
Estimated Study Completion Date: | 02/27/2021 |
Condition or disease
Intervention/treatment
Radiation: Photobiomodulation group
Radiation: Control group
Phase
Arm Groups
Arm | Intervention/treatment |
---|---|
Active Comparator: Photobiomodulation group PBM will be applied after the surgeries with extra and intraoral LED devices. The LED plates speed up the treatment as they deliver all the energy at once, having the advantage of radiating several points at the same time. The applications of both will occur in the following experimental periods after the end of the surgeries: immediate postoperative, 1, 2, 7, 14, 30, 60 and 90 days. | Radiation: Photobiomodulation group PBM will be applied with extra and intraoral LED devices. The LED plates speed up the treatment as they deliver all the energy at once, having the advantage of radiating several points at the same time. The applications of both will occur in the following experimental periods after the end of the surgeries: immediate postoperative, 1, 2, 7, 14, 30, 60 and 90 days. |
Placebo Comparator: Control group Participants will be attended in the same way as the PBM group. The person who is responsible for the application of the PMB will simulate the irradiations by positioning the devices in the same locations described for the PBM group, but the equipment will be kept off. | Radiation: Control group The person responsible for applying the PBM will simulate the irradiation by positioning the devices in the same locations described for the PBM group, but the equipment will be kept off |
Eligibility Criteria
Ages Eligible for Study | 18 Years To 18 Years |
Sexes Eligible for Study | All |
Accepts Healthy Volunteers | Yes |
Criteria | Inclusion Criteria: - Transverse maxillary deficiency ˃ of 5 mm with bilateral posterior crossbite and indication for surgical maxillary disjunction. - Agree to participate in the study after reading and signing the Term of Consent for Participation in Clinical Research. Exclusion Criteria: - Transverse maxilla deficiency, with unilateral posterior crossbite. - Local or systemic alterations that contraindicate surgical intervention or hinder the postoperative period. - Smokers. - Display photo sensitivity history. - Possess systemic diseases, chronic pain or neurological and psychiatric disorders. - Have been using anti-inflammatories, analgesics or bisphosphonates in the past 15 days. - Pregnant. - Breastfeeding. - Participants who present any type of complication during surgery (hemorrhage, operative difficulty), as these cases will not be in the expected pattern for these surgeries. These data will not be part of the statistical analysis but will be described and discussed, as well as possible adverse effects. |
Outcome
Primary Outcome Measures
1. Change in Pain [After 1, 2, 7 and 14 days of surgeries.]
2. Change in Edema [After 1, 2, 7 and 14 days of surgeries.]
3. Change in intra and extraoral sensitivity [After 7, 30, 60, 90 and 120 days of surgeries.]
4. Change in postoperative bone repair [After 30, 60, 90 and 120 days of surgeries.]
Secondary Outcome Measures
1. Change in temperature [After 1, 2, 7 and 14 days of surgeries.]
2. Presence of headache [After 1, 2, 7 and 14 days of surgeries.]
3. Presence of bruises [After 1, 2, 7 and 14 days of surgeries.]
4. Presence of otalgia [After 1, 2, 7 and 14 days of surgeries.]
5. Presence of nausea [After 1, 2, 7 and 14 days of surgeries.]
6. Presence of nasolacrimation [After 1, 2, 7 and 14 days of surgeries.]
7. Presence of nose bleeding [After 1, 2, 7 and 14 days of surgeries.]
8. Presence of dysphagia [After 7 and 30 days of surgeries.]
9. Postoperative quality of life [After 7 and 30 days of surgeries.]