An interventional study of Liquid Platelet-Rich Fibrin group and low-level laser group in Gummy Smile, sponsored by Damascus University. Recruiting at 1 site in Syria. Open to participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2026-04-29.
Sponsored by Damascus University · Not applicable, Interventional, and Treatment
A gummy smile can negatively affect a patient's self-confidence and satisfaction with their appearance, leading many individuals to seek effective esthetic solutions. The etiology of this condition varies and may include vertical maxillary excess, short upper lip, hyperactive upper lip, gingival enlargement, or altered passive eruption.
Lip Repositioning Surgery is one of the minimally invasive esthetic surgical procedures used to reduce the amount of gingival display during smiling. Despite its effectiveness, this surgery may be associated with challenges such as pain, swelling, delayed wound healing, and the possibility of postoperative relapse over time, which could compromise both esthetic and functional outcomes.
To overcome these challenges and enhance surgical outcomes, adjunctive techniques have been introduced to promote healing and determine whether enhancing the biological healing process can reduce the rate of relapse after LRS. Among the most prominent of these are Injectable Platelet-Rich Fibrin (i-PRF) and Low-Level Laser Therapy (LLLT).
Exclusion Criteria:
This group will consist of 11 patients presenting with excessive gingival display due to upper lip hypermobility. Each patient will undergo lip repositioning surgery, followed by immediate injection of Liquid Platelet-Rich Fibrin after completion of the surgical procedure.
Other: Liquid Platelet-Rich Fibrin group
This group will consist of 11 patients presenting with excessive gingival display due to upper lip hypermobility. Each patient will undergo lip repositioning surgery, followed by immediate application of low-level laser therapy (LLLT) after completion of the surgical procedure and at 3,7,10, and 14 days after surgery.
Other: low-level laser group
A partial thickness elliptical mucogingival incision was made from the mesial of the central incisor to the mesial of the first molar bilaterally with preservation of the frenulum; vertical height set to twice the excessive gingival display (2:1 ratio), lower margin 1 mm coronal to the mucogingival junction. Epithelium elevated to expose connective tissue (preserving minor salivary glands). Periosteal sutures (4-0 Vicryl, 2-3 per side) placed where connective tissue ≥0.5 mm ; incision edges approximated with simple interrupted 4-0 silk sutures. 20 mL blood collected into additive-free plastic tubes and centrifuged at 300 × g for 5 minutes. The Liquid Platelet-Rich Fibrin layer was aspirated and injected immediately after surgery along incision margins and surrounding tissue at 1 mm depth, multiple points 2-3 mm apart (≈0.1 mL per injection) to achieve homogeneous distribution.
A partial thickness elliptical mucogingival incision was made from the mesial of the central incisor to the mesial of the first molar bilaterally with preservation of the frenulum; vertical height set to twice the excessive gingival display (2:1 ratio), lower margin 1 mm coronal to the mucogingival junction. Epithelium elevated to expose connective tissue (preserving minor salivary glands). Periosteal sutures (4-0 Vicryl, 2-3 per side) placed where connective tissue ≥0.5 mm to ; incision edges approximated with simple interrupted 4-0 silk sutures. low-level laser applied to the surgical site (635nm, 200 mW) as part of the post-surgical treatment and at 3,7,10, and 14 days after surgery.
Gingival display (mm)
Measured in millimeters from the lowest point of the upper lip vermilion border to the free gingival margin of the maxillary teeth (from right second premolar to left second premolar) during full smile.
Time frame: Baseline and 1, 3 and 6 months postoperatively
Wound Healing Index
Wound healing will be assessed using the Wound Healing Index (Huang, Neiva, and Wang, 2005). This is a categorical scale with scores ranging from 1 to 3: 1. = poor healing (significant gingival swelling or redness, severe patient discomfort, slough formation with suppuration); 2. = good healing (mild gingival swelling or redness, mild patient discomfort, slough formation without suppuration); 3. = complete healing (no gingival swelling, redness, suppuration, or patient discomfort, and no slough formation). Higher scores indicate better healing outcomes.
Time frame: weekly for 4 weeks postoperatively
Postoperative Pain (VAS 0-100)
Postoperative pain assessed using patient self-reported Visual Analogue Scale (VAS, 0-100), where 0 indicates no pain and 100 indicates worst possible pain. Pain will be recorded daily for the first 7 days after surgery.
Time frame: Days 1-7 postoperatively
Postoperative Edema/Swelling
Postoperative edema/swelling assessed on the third day after surgery using a clinician-reported rating scale: 0 = no visible oedema; 1. = slight oedema (intra- oral swelling in the surgical zone); 2. = moderate oedema (extra- oral swelling in the surgical area); 3. = severe oedema (extra- oral swelling extending the surgical site) and/or visible hematoma and ecchymosis
Time frame: Day 3 postoperatively
Esthetic Satisfaction (VAS 0-100)
Esthetic satisfaction assessed using patient self-reported Visual Analogue Scale (VAS, 0-100), where 0 indicates completely dissatisfied and 100 indicates completely satisfied. Evaluation will be performed 6 months postoperatively.
Time frame: 6 months postoperatively
Upper Lip External Length
Measured from the base of the nose to the lower edge of the vermilion border of the upper lip, assessed at both resting and maximum smiling positions
Time frame: Baseline, 1,3 and 6 months postoperatively
Upper Lip Internal Length
Measured at rest and smile to assess the dimensions of the internal upper lip
Time frame: Baseline, 1, 3 and 6 months postoperatively
Intraoperative complications
Any complication during the surgery will be recorded for reporting. A score of 0 will be assigned when none of complications are observed, whereas a score of 1 will be assigned if any complication occurs.
Time frame: During surgery
Post-operative complications
Any complication related to the surgical intervention and healing following the surgical treatment such as infection, or sensory disturbances will be recorded for reporting. A score of 0 will be assigned when none of these complications are observed, whereas a score of 1 will be assigned if any of them occur.
Time frame: First week postoperatively
Plan to share: No
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Damascus University