Palatal Wound Clinical Trial
— LLLTOfficial title:
Effect of Gallium-Aluminum-Arsenide Laser - AsGaAl Low-level Laser Therapy on the Healing of Human Palate Mucosa After Connective Tissue Graft Harvesting: Randomized Clinical Trial
The aim of the present study was to evaluate the influence of LLLT on the recovery of the palatine donor site wounds after harvest connective tissue graft.
Status | Completed |
Enrollment | 32 |
Est. completion date | June 2013 |
Est. primary completion date | June 2013 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 20 Years to 70 Years |
Eligibility |
Inclusion Criteria: - Patients that were 20 to 70 years old, both genders; presenting gingival recession Class I or II Miller, on vital canines or pre-molars, palatine region (donor site) with no pathological or morphological alterations; patients who agreed with and signed the formal consent to participate in the study, after receiving an explanation of risks and benefits, by an individual who was not a member of the present study (Resolution no. 196 - October, 1996, and Ethics and Code of Professional Conduct in Dentistry - CFO 179/93). Exclusion Criteria: - Patients with systemic problems that contraindicated surgical procedure; patients under medication that would interfere with the wound healing; patients who smoked; patients who were pregnant or lactating; patients who had had periodontal surgery on the study area. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Brazil | Fosjc-Unesp | São Jose dos Campos/ SP | Non-US Resident |
Lead Sponsor | Collaborator |
---|---|
UPECLIN HC FM Botucatu Unesp |
Brazil,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Tissue thickness | Through four fixed points (5mm and 7mm distant to gingival margin) from the operated region, tissue thickness of palatine masticatory mucosa before the procedure and 3 months after the procedure were assessed. One stent was made to standardize the points to be measured. The stent was positioned and, with a periodontal probe, the points were marked. Then the stent was removed and measures were made. For this, an endodontic spacer with a rubber cursor was put on the marked points for it to reach palatine bone plate. Then the cursor was taken to the tissue, not pressuring it. The distance between the spacer tip to the cursor was measured using a digital caliper | Before and 90 days after surgery | No |
Primary | Change in the Remaining wound area (RWA) | For this, standardized photographs were taken (brightness, distance and angle). A scale was used as a reference to measure this area. Theses photographs were exported to image software (Image J - NIH, Bethesda, USA) and the wound area was measured in square millimeters | 7, 14, 45 and 60 post-operative days | No |
Secondary | Post-operative discomfort | After air spray application, patients were required to fill a visual analogue scale (VAS), of 100mm, where the scale extremes were "no pain" to "extreme" to report measurement discomfort. | 7, 14, 45 and 60 days after surgical procedure | No |
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