Status:
UNKNOWN
Photobiomodulation Effects on Pain, Edema, Paresthesia and Bone Regeneration After Maxillar Surgical Disjunction
Lead Sponsor:
University of Nove de Julho
Conditions:
Maxillary Diseases
Eligibility:
All Genders
18-45 years
Phase:
PHASE2
Brief Summary
The objective of the present study will be to evaluate the efficacy of photobiomodulation (PBM) with LED in pain control, facial edema, paresthesia, bone repair and quality of life arising after maxil...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 2 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 28 2021
Estimated Enrollment :
72 Patients enrolled
Trial Details
Trial ID
NCT03814525
Start Date
January 2 2019
End Date
February 28 2021
Last Update
January 24 2019
Active Locations (1)
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1
Conjunto Hospitalar do Mandaqui
São Paulo, São Paulo, Brazil, 02402-500