Clinical Evaluation of the Effects of Low-Level Laser Therapy and Hyaluronic Acid Application on Graft Shrinkage and Postoperative Morbidity Following Free Gingival Graft
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Graft Shrinkage
Study Overview
Brief Summary
The goal of this randomized clinical trial was to learn whether low-level laser therapy or hyaluronic acid application improves healing after free gingival graft surgery in adults with insufficient keratinized gingival tissue in the mandibular lower teeth region.
The main questions it aimed to answer were:
- Do low-level laser therapy and hyaluronic acid application reduce shrinkage of the gingival graft?
- Do these treatments reduce postoperative pain and pain medication use and improve wound healing, clinical outcomes, appearance, and oral health-related quality of life?
Researchers compared three groups: free gingival graft surgery alone, free gingival graft surgery with low-level laser therapy and free gingival graft surgery with hyaluronic acid application.
Participants underwent free gingival graft surgery and were followed for six months. During follow-up, researchers measured graft size and shrinkage, periodontal clinical measurements, pain at the donor and recipient sites, pain medication use, wound healing, esthetic outcomes, and oral health-related quality of life.
Detailed Description
This randomized controlled clinical trial evaluated the effects of low-level laser therapy and hyaluronic acid application on graft shrinkage, postoperative morbidity, wound healing, clinical outcomes, esthetic results, and oral health-related quality of life following free gingival graft surgery. Adult participants with insufficient keratinized gingival tissue in the mandibular anterior region were randomly assigned to one of three parallel groups: free gingival graft surgery alone as the control group, free gingival graft surgery combined with low-level laser therapy, or free gingival graft surgery combined with hyaluronic acid application. All participants underwent a standardized free gingival graft procedure. In the low-level laser therapy group, an 810-nm diode laser was applied at 0.1 W in continuous-wave mode for 60 seconds on the day of surgery and on postoperative days 1, 3, 7, and 14. In the hyaluronic acid group, 0.8% hyaluronic acid gel was applied in addition to the surgical procedure, while the control group received no additional treatment. Postoperative pain at the donor and recipient sites was assessed using a visual analog scale during the first seven postoperative days, and analgesic consumption was recorded. Donor-site epithelialization and early wound healing were evaluated on postoperative days 7, 14, and 21. Clinical periodontal measurements, including recession depth, recession width, vestibular depth, keratinized tissue width, probing depth, plaque index, gingival index, and bleeding on probing, were recorded at baseline and at the 1-, 3-, and 6-month follow-up visits. Graft dimensions and shrinkage were assessed using standardized clinical photographs and digital image analysis, while esthetic outcomes were evaluated during the 3- and 6-month follow-up periods. Oral health-related quality of life was assessed at baseline and at 6 months.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Voluntary participation and provision of written informed consent
- •Systemically healthy adults aged 18 years or older
- •Non-smokers
- •No known drug allergies
- •Not pregnant or breastfeeding
- •Presence of Cairo RT1 or RT2 gingival recession in the mandibular anterior region
- •Keratinized tissue width of less than 2 mm at the planned grafting site
- •Plaque Score below 20% and Bleeding on Probing score below 20%
- •Vital teeth in the surgical area
Exclusion Criteria
- •Current use of medications that may interfere with wound healing or are contraindicated for surgical procedures
- •Pregnancy or breastfeeding
- •Ongoing orthodontic treatment in the affected region
- •History of previous periodontal surgery in the study area
- •Presence of active periodontal disease
- •Probing pocket depth greater than 3 mm in the involved teeth
Arms & Interventions
Control Group
Participants underwent standardized free gingival graft surgery without additional low-level laser therapy or hyaluronic acid application.
Intervention: Free Gingival Graft Surgery (Procedure)
Low-Level Laser Therapy Group
Participants underwent standardized free gingival graft surgery and received low-level laser therapy using an 810-nm diode laser at 0.1 W in continuous-wave mode for 60 seconds on the day of surgery and on postoperative days 1, 3, 7, and 14.
Intervention: Low-Level Laser Therapy (Device)
Hyaluronic Acid Group
Participants underwent standardized free gingival graft surgery. A 0.8% hyaluronic acid gel was applied topically to the palatal donor site immediately after surgery. Participants were also instructed to apply the hyaluronic acid gel to the palatal donor site three times daily for two weeks.
Intervention: Topical Hyaluronic Acid Gel (Device)
Outcomes
Primary Outcomes
Graft Shrinkage
Time Frame: Baseline and Months 1, 3, and 6
Free gingival graft area was measured from standardized clinical photographs using ImageJ software. Graft shrinkage was calculated as the percentage reduction in graft area compared with the baseline postoperative graft area. Higher percentage values indicate greater graft shrinkage.
Secondary Outcomes
- Postoperative Pain(Postoperative Days 1 through 7)
- Modified Pink Esthetic Score(Baseline and Months 3 and 6)
- Oral Health-Related Quality of Life Assessed by OHIP-14(Baseline and Month 6)
- Postoperative Analgesic Consumption(Postoperative Days 1 through 7)
- Change in Probing Pocket Depth(Baseline and 1, 3, and 6 months after surgery)
- Change in Plaque Score(Baseline and 1, 3, and 6 months after surgery)
- Change in Bleeding on Probing Score(Baseline and 1, 3, and 6 months after surgery)
- Keratinized Tissue Thickness(Baseline)
- Change in Gingival Recession Depth(Baseline and 1, 3, and 6 months after surgery)
- Change in Gingival Recession Width(Baseline and 1, 3, and 6 months after surgery)
- Change in Vestibular Depth(Baseline and 1, 3, and 6 months after surgery)
Investigators
Deniz Barlas
PhD Candidate, Department of Periodontology
Altinbas University