Gingival Recession, Mucogingival Surgery
Conditions
Keywords
Insufficient Keratinized Gingiva, Low-Level Laser Therapy, Hyaluronic Acid, Graft Shrinkage, Postoperative Pain, Keratinized Gingiva
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.
Interventions
DEVICETopical Hyaluronic Acid Gel
A 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.
DEVICELow-Level Laser Therapy
Low-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.
PROCEDUREFree Gingival Graft Surgery
A 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.
Sponsors
Altinbas University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Intervention model description
Participants were randomly assigned to 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. Participants remained in their assigned groups throughout the six-month follow-up period.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Graft Shrinkage | 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
| Measure | Time frame | Description |
|---|---|---|
| Change in Plaque Score | Baseline and 1, 3, and 6 months after surgery | Plaque accumulation was assessed dichotomously as present or absent using a periodontal probe. Measurements were performed at four surfaces of each tooth: mesiobuccal, mid-buccal, distobuccal, and mid-lingual/palatal. The plaque score was calculated by dividing the number of plaque-positive surfaces by the total number of examined surfaces and multiplying by 100. Scores range from 0% to 100%, with lower scores indicating better plaque control. |
| Postoperative Analgesic Consumption | Postoperative Days 1 through 7 | 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. |
| Postoperative Pain | Postoperative Days 1 through 7 | 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. |
| Modified Pink Esthetic Score | Baseline and Months 3 and 6 | 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. |
| Oral Health-Related Quality of Life Assessed by OHIP-14 | Baseline and Month 6 | 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. |
| Change in Bleeding on Probing Score | Baseline and 1, 3, and 6 months after surgery | Bleeding on probing was assessed using a UNC-15 periodontal probe at six sites per tooth. A site was recorded as positive when bleeding occurred within 10 to 15 seconds after probing and negative when no bleeding occurred. The bleeding on probing score was calculated by dividing the number of bleeding-positive sites by the total number of examined sites and multiplying by 100. Scores range from 0% to 100%, with lower scores indicating less gingival inflammation. |
| Keratinized Tissue Thickness | Baseline | Keratinized tissue thickness was measured in millimeters at the mid-buccal aspect of the treated tooth, at the midpoint between the gingival margin and the mucogingival junction. Under local anesthesia, a number 25 endodontic spreader with a silicone stop was inserted perpendicular to the tissue until hard tissue was contacted. The penetration depth was subsequently determined by placing the spreader beside a periodontal probe and measuring the distance from the tip of the spreader to the silicone stop. Higher values indicate greater keratinized tissue thickness. |
| Change in Gingival Recession Depth | Baseline and 1, 3, and 6 months after surgery | Gingival recession depth was measured in millimeters using a UNC-15 periodontal probe and an individualized 2-mm-thick transparent acrylic splint. A vertical reference groove was prepared on the splint parallel to the long axis of the treated tooth to ensure reproducible probe positioning. The distance from the cementoenamel junction to the gingival margin was recorded. Lower values indicate a reduction in gingival recession depth. |
| Change in Gingival Recession Width | Baseline and 1, 3, and 6 months after surgery | Gingival recession width was measured in millimeters at the widest horizontal dimension of the recession defect. A periodontal probe was positioned horizontally between the mesial and distal margins of the gingival recession at the midline of the defect. Lower values indicate a reduction in gingival recession width. |
| Change in Probing Pocket Depth | Baseline and 1, 3, and 6 months after surgery | Probing pocket depth was measured in millimeters using a UNC-15 periodontal probe. The distance from the gingival margin to the base of the periodontal pocket was recorded at six sites per tooth: mesiobuccal, mid-buccal, distobuccal, mesiolingual/palatal, mid-lingual/palatal, and distolingual/palatal. Lower values indicate shallower periodontal pockets. |
| Change in Vestibular Depth | Baseline and 1, 3, and 6 months after surgery | Vestibular depth was measured in millimeters using a periodontal probe and an individualized transparent splint. The probe was positioned within a vertical reference groove on the splint, parallel to the long axis of the treated tooth, and advanced until the mucogingival junction was reached. The distance between the lower border of the splint and the mucogingival junction was recorded as the vestibular depth. Higher values indicate greater vestibular depth. |
Countries
Turkey (Türkiye)
Contacts
CONTACTDeniz BARLAS, PHD in periodontology
STUDY_DIRECTORŞebnem Dirikan İpçi, Prof.
Altınbas University Dental Hospital
Outcome results
None listed