An interventional study of Diode Laser Photobiomodulation (claros pico) and Customized Acrylic Palatal Stent in Mucogingival Deformity - Insufficient Keratinized Tissue, Lack of Keratinized Tissue and Wound Healing, sponsored by Gulf Medical University. Active, not recruiting at 1 site in United Arab Emirates. Open to participants aged 18 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-11-09.
Sponsored by Gulf Medical University · Not applicable, Interventional, and Treatment
Harvesting a free gingival graft (FGG) creates an open wound on the roof of the mouth (palate) that heals by secondary intention. This healing process is frequently associated with postoperative pain, bleeding, functional discomfort during eating, and delayed tissue recovery. Standard care often involves using a custom plastic protective guard (palatal stent) to cover the open wound. Low-level light therapy, known as diode laser photobiomodulation (PBMT), is a non-invasive treatment proposed to stimulate cellular energy production and accelerate soft tissue healing. The purpose of this randomized controlled clinical trial is to evaluate whether diode laser photobiomodulation improves palatal donor site wound healing and reduces postoperative pain and discomfort compared with conventional palatal stent protection. A total of 50 systemically healthy adult participants requiring free gingival graft surgery will be randomly assigned to receive either diode laser photobiomodulation or a customized palatal stent. Wound healing will be monitored over a 28-day follow-up period using 3D digital intraoral scanning to measure wound size reduction, hydrogen peroxide testing to confirm complete skin re-coverage (re-epithelialization), clinical healing indices, and visual color match with surrounding tissues. Patient-reported outcomes, including pain levels, daily painkiller tablet consumption, difficulty chewing, burning sensations, bleeding episodes, and overall satisfaction, will also be recorded
Background and Rationale Autogenous soft tissue grafting remains the gold standard in periodontal plastic surgery for augmenting keratinized tissue and modifying thin gingival phenotypes around teeth and dental implants. The palate is the primary donor site due to its anatomical availability and histological suitability. However, harvesting a free gingival graft leaves an open donor wound that heals by secondary intention, resulting in substantial morbidity including pain, localized bleeding, delayed epithelialization, and functional impairment during mastication. Photobiomodulation therapy (PBMT) utilizes low-level laser irradiation to trigger biological responses via mitochondrial chromophore activation, enhanced adenosine triphosphate (ATP) synthesis, stimulation of fibroblast and keratinocyte proliferation, angiogenesis, and inflammatory modulation. While PBMT shows potential for accelerating soft tissue repair, direct comparative evidence regarding its clinical effectiveness versus conventional mechanical protection using an acrylic palatal stent remains limited and inconsistent. This study is designed to directly evaluate the clinical effectiveness of diode laser PBMT versus conventional acrylic palatal stent protection.
Study Design and Setting This study is a single-center, parallel-group, single-blinded randomized controlled clinical trial with a 1:1 allocation ratio, conducted at Thumbay Dental Hospital, Gulf Medical University Complex in Ajman, United Arab Emirates. The study protocol will enroll 50 adult participants needing free gingival graft harvesting. Preoperative Assessment and StandardizationAll participants undergo initial periodontal therapy to achieve a Full-Mouth Plaque Score (FMPS) $\le 20\%$ and Full-Mouth Bleeding Score (FMBS) $\le 20\%$. Palatal tissue thickness is evaluated transgingivally under local anesthesia at the premolar-molar region using a No. 15 endodontic reamer with a silicone stopper and digital caliper measurements. A minimum palatal tissue thickness of 3 mm is required for inclusion to allow harvesting of a 1.5 mm graft while preserving sufficient connective tissue cover over the palatal bone.
Surgical Protocol All surgical procedures are performed by a single experienced periodontist under local anesthesia using 4% Articaine with 1:100,000 epinephrine. Recipient site preparation follows standard mucogingival surgical principles. Donor wound dimensions are standardized to approximately $10 \times 15\text{ mm}$ using a sterile aluminum foil template. A free gingival graft with a uniform thickness of 1.5-2.0 mm is harvested using a No. 15 surgical blade. Primary hemostasis is achieved by gentle manual compression with sterile wet gauze. Participants are then randomly allocated via computer-generated sequence and sequentially numbered opaque sealed envelopes to one of two treatment groups: Test Group (Photobiomodulation): Receives PBMT using a claros® pico diode laser ($808 \pm 10\text{ nm}$ wavelength, 1 W continuous wave output, $5\text{ J/cm}\^2$ energy density per point, 30 seconds exposure per point). The laser application is performed in non-contact mode at approximately 1 mm distance from the wound bed across 5 standardized points (4 peripheral corners and 1 central point). Irradiation is performed immediately after surgery (Day 0) and on postoperative Days 1, 3, and 7. Control Group (Palatal Stent): Receives a customized acrylic palatal stent fabricated from preoperative impressions. The stent is fitted immediately after surgery, and participants are instructed to wear it continuously for the first 7 postoperative days, removing it only for oral hygiene routines. Postoperative ProtocolAll participants receive standardized postoperative systemic therapy consisting of Amoxicillin/clavulanic acid 1 g twice daily for 5 days (or an alternative in cases of penicillin allergy), Ibuprofen 600 mg three times daily for 3 days (or as needed for pain), and twice-daily 0.12-0.2% chlorhexidine mouth rinses for 2 weeks. Mechanical tooth brushing at the surgical sites is restricted during the early healing phase, and a soft diet is required for 1 week.
Assessment Timeline and Follow-Up Protocols
Clinical examinations, digital 3D intraoral scans (STL files), photographic documentation, and questionnaire evaluations are performed by a calibrated examiner blinded to group allocation at scheduled time points: Baseline ($T_0$): Post-harvesting digital intraoral STL scan and clinical photography to document baseline wound area. Day 3: Evaluation of early wound healing using the Palatal Mucosal Wound Healing Index (PMWHI; immediate healing parameters), VAS pain scores (0-100 mm), daily analgesic tablet count, functional morbidity VAS scores (0-10), and complication tracking. Day 7: 3D intraoral STL scan superimposition to calculate percentage wound closure; 3% hydrogen peroxide ($\text{H}_2\text{O}_2$) bubbling test for re-epithelialization; PMWHI score; tissue color match VAS score (0-10); VAS pain, functional morbidity, and analgesic consumption counts. Day 14: Delayed healing PMWHI evaluation; 3% $\text{H}_2\text{O}_2$ re-epithelialization test; 3D STL scan superimposition; tissue color match VAS score; VAS pain and morbidity scores. Day 21: PMWHI score; 3% $\text{H}_2\text{O}_2$ re-epithelialization test; 3D STL scan superimposition; tissue color match VAS score; functional morbidity tracking. Day 28: Final 3D STL scan superimposition for primary outcome (% wound closure); 3% $\text{H}_2\text{O}_2$ re-epithelialization test; PMWHI score; tissue color match assessment; overall patient satisfaction score; comprehensive adverse event and complication record. 3 Months: Extended follow-up PMWHI assessment.
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This study's planned enrollment of 50 is below the median of 75 across 4,821 interventional studies indexed under Pain, Postoperative.
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Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
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Participants wearing a customized acrylic protective palatal stent over the donor site following free gingival graft harvesting
Device: Customized Acrylic Palatal Stent
articipants receiving diode laser photobiomodulation therapy at the palatal donor site following free gingival graft harvesting.
Device: Diode Laser Photobiomodulation (claros pico)
Low-level laser therapy using an 808 nm diode laser in continuous wave mode (1 W output, energy density 5 J/cm² per point for 30 seconds/point). Applied in non-contact mode (\~1 mm distance) across 5 standardized points (4 peripheral corners and 1 central point) immediately post-surgery (Day 0) and on postoperative Days 1, 3, and 7.
Pre-fabricated acrylic palatal stent placed immediately over the palatal wound following surgery and worn continuously by the participant for the first 7 postoperative days (removed only for routine oral hygiene).
Percentage of Palatal Wound Closure
Quantitative percentage reduction in palatal donor site wound area measured via 3D superimposition of digital intraoral scan files (STL format) relative to baseline ($T\_0$). Calculated as:$$\\text{Wound Closure (\\%)} = \\frac{\\text{Baseline Area } (T\_0) - \\text{Remaining Area } (T\_x)}{\\text{Baseline Area } (T\_0)} \\times 100$$
Time frame: Baseline ($T_0$), Postoperative Days 7, 14, and 28
Degree of Complete Re-Epithelialization
Binary assessment (Complete/Incomplete) of tissue re-epithelialization using the 3% hydrogen peroxide ($\\text{H}\_2\\text{O}\_2$) bubbling test. The absence of oxygen bubbling upon application indicates complete epithelial coverage over the palatal wound bed.
Time frame: Postoperative Days 7, 14, 21, and 28
Quality of Palatal Wound Healing (PMWHI Score)
Evaluation of soft tissue healing quality measured using the Palatal Mucosal Wound Healing Index (PMWHI, total score range 0-17). Lower scores represent superior healing (0-4: excellent, 5-8: satisfactory, 9-12: fair, 13-17: poor).
Time frame: Postoperative Days 3, 7, 14, 21, 28, and 3 months
Tissue Color Match
Assessment of color match between the regenerating donor site mucosa and surrounding unoperated palatal tissue, evaluated on a 10-point Visual Analog Scale (VAS 0-10, where 0 = complete mismatch and 10 = identical color match).
Time frame: Postoperative Days 7, 14, 21, and 28
Postoperative Pain Intensity
Patient-reported post-surgical pain intensity recorded using a 100-mm Visual Analog Scale (VAS 0-100 mm, where 0 mm = no pain and 100 mm = worst imaginable pain)
Time frame: Baseline ($T_0$), Postoperative Days 3, 7, and 14
Analgesic Consumption
Total quantity of rescue pain medication (number of 600 mg Ibuprofen tablets) consumed by the participant per day for pain control.
Time frame: Daily during the first 7 postoperative days
Functional Morbidity
Patient-reported assessment of post-surgical functional impairment, including chewing/mastication difficulty, burning sensation, and bleeding discomfort, evaluated on a 10-point Visual Analog Scale (VAS 0-10)
Time frame: Postoperative Days 3, 7, 14, and 28
Postoperative Complications
Incidence and severity of post-surgical complications, including secondary bleeding, swelling, hematoma, localized infection, delayed wound healing, speech impairment, or difficulty maintaining oral hygiene, recorded as binary incidence and event counts
Time frame: Up to 28 days postoperatively
Plan to share: Undecided
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Gulf Medical University