Wounds Clinical Trial
Official title:
Low-level Laser Therapy in Enhancing Wound Healing and Preserving Tissue Thickness at Free Gingival Graft Donor Sites: A Randomised Controlled Clinical Study
Verified date | August 2016 |
Source | Karadeniz Technical University |
Contact | n/a |
Is FDA regulated | No |
Health authority | Turkey: Ethics Committee |
Study type | Interventional |
Objective: The aim of this study was to determine the effects of Low Level Laser Therapy
(LLLT) on wound healing at Free Gingival Graft donor sites (FGGDS).
Materials and Methods: Forty patients requiring FGG were selected for this randomized
controlled double blinded prospective clinical trial. The FGGDS were treated with LLLT and
compared with an untreated control group. The Wound Healing Index (WHI), tissue consistency,
colour match (CM), and H2O2 bubbling test for the evaluation of complete wound
epithelialization (CWE) were recorded at the 3rd, 7th, 14th and 21st days. The pain-burning
level, number of analgesics, and bleeding were recorded for 7 days. Donor area soft tissue
thickness (TT) was measured at baseline and at the 1st month.
Status | Completed |
Enrollment | 40 |
Est. completion date | August 2015 |
Est. primary completion date | August 2015 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years to 65 Years |
Eligibility |
Inclusion Criteria: 1. The absence of systemic factors (no systemic disease, no coagulation disorders, no medications affecting periodontal status, and no pregnancy or lactation) 2. No smoking 3. Patients who had a full mouth plaque score (FMPS)?20% and a full mouth bleeding score (FMBS)?20% 4. No periodontal surgery on the experimental site 5. No nauseal reflection Exclusion Criteria: 1. Smoking 2. The presence of systemic disease 3. Bad oral hygiene- 4. The history of periodontal surgery on the experimental site 5. Nauseal reflection |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Karadeniz Technical University |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Complete Wound Epithelization | The 14th day H2O2 Bubbling test results that show Complete Wound Epithelization | 14th. day after surgery | No |
Secondary | Palatal Tissue Thickness | The tissue thickness alterations (mm.) that was measured by a endodontic reamer and digital caliper was the secondary outcome | at baseline and at the 1st month | No |
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