Effects of Low-Level Laser Therapy and Hyaluronic Acid After Free Gingival Graft
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorAltinbas University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Voluntary participation and provision of written informed consent
Systemically healthy adults aged 18 years or older
Non-smokers
No known drug allergies
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Topical Hyaluronic Acid Gel
DeviceA 0.8% hyaluronic acid gel was applied directly to the recipient bed immediately before placement and stabilization of the free gingival graft. The gel was also applied topically to the palatal donor site immediately after surgery. Participants were prescribed the same gel and instructed to apply it to the palatal donor site three times daily for 14 days.
Low-Level Laser Therapy
DeviceLow-level laser therapy was administered to the palatal donor site and the recipient site using an 810-nm diode laser at 0.1 W in continuous-wave mode for 60 seconds. Laser applications were performed immediately after free gingival graft surgery and repeated on postoperative days 1, 3, 7, and 14.
Free Gingival Graft Surgery
Procedure/SurgeryA standardized free gingival graft was harvested from the palatal donor site and placed and stabilized at the recipient site in the mandibular anterior region to increase the width of keratinized gingiva.
Treatment groups
30 Participants
are divided into 3 treatment groupsGroup A: Control GroupActive comparator 1 intervention
Group B: Low-Level Laser Therapy GroupExperimental treatment 1 intervention
Group C: Hyaluronic Acid GroupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Graft Shrinkage
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.
Time frame
Baseline and Months 1, 3, and 6Secondary outcomes
1
Postoperative Pain
Postoperative pain at the palatal donor site and mandibular recipient site was recorded separately using a visual analog scale ranging from 0 to 10, where 0 indicated no pain and 10 indicated the worst imaginable pain. Lower scores indicate less postoperative pain.
Time frame
Postoperative Days 1 through 72
Modified Pink Esthetic Score
In this study, the Pink Esthetic Score (PES) was adapted from the original index described by Belser et al. (2009). The index was considered modified (m-PES) because the original PES was developed to evaluate peri-implant soft tissue esthetics, whereas no implants were placed in the present study. Instead, the scoring criteria were applied to free gingival graft (FGG)-treated sites, using the adjacent healthy teeth as the reference for esthetic evaluation. The m-PES included seven variables: mesial papilla, distal papilla, facial mucosal curvature, facial mucosal level, alveolar process deficiency, and the color and texture of the facial soft tissue. Each parameter was scored as 0, 1, or 2, with higher scores indicating a more favorable esthetic outcome. The m-PES was assessed at baseline and at the 6-month follow-up. This modified index was selected because it provides a standardized, objective, and reproducible method for evaluating soft tissue esthetic changes over time.
Time frame
Baseline and Months 3 and 63
Oral Health-Related Quality of Life Assessed by OHIP-14
Oral health-related quality of life was assessed using the validated Turkish version of the 14-item Oral Health Impact Profile (OHIP-14). The questionnaire includes seven domains: functional limitation, physical pain, psychological discomfort, physical disability, psychological disability, social disability, and handicap. Each item was scored from 0 (never) to 4 (very often), resulting in a total score ranging from 0 to 56. Lower scores indicate better oral health-related quality of life.
Time frame
Baseline and Month 64
Postoperative Analgesic Consumption
Postoperative analgesic consumption was assessed by recording the number of tablets taken by each participant during the first seven days following free gingival graft surgery. Participants recorded their daily analgesic intake, and the total number of tablets consumed during the postoperative evaluation period was calculated.
Time frame
Postoperative Days 1 through 7Sponsors and contacts
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Source ClinicalTrials.gov