Comparison Between Liquid Fibrin and Soft Laser Effects on Healing and Relapse After Lip Repositioning Surgery

N/ANot Yet RecruitingNCT07532161

Damascus University22 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Gummy Smile

Interventions

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.

low-level laser groupOTHER

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 50 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Patients of both genders. 2. Patients presenting with a gummy smile in the maxillary anterior region (more than 3 mm) due to upper lip hypermobility. 3. Age 18-50 years. 4. Systemically healthy individuals, classified as ASA physical status I or II according to the American Society of Anesthesiologists (ASA) classification; that is, patients without systemic disease or with mild, well-controlled systemic conditions. 5. Patients with good oral hygiene, defined as an O'Leary Plaque Index ≤ 40%. 6. No previous lip repositioning surgery. Exclusion Criteria: 1. Pregnancy and lactation. 2. Individuals with a previous history of receiving facial Botox or filler injections. 3. Systemic diseases or conditions that contraindicate the use of local anesthesia. 4. Any physical condition that impairs the ability to perform proper oral hygiene measures. 5. Patients who are smokers or alcohol consumers. 6. Inability or unwillingness to cooperate. 7. In adequate width of attached gingiva. 8. Vertical maxillary excess (moderate to severe) requiring orthognathic intervention. 9. Short upper lip 10. Gingival display primarily caused by altered passive eruption requiring crown lengthening.

Outcomes

Primary Outcomes

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 assessed clinically using the Wound Healing Index (Huang, Neiva, and Wang, 2005). Healing is classified into three categories: Complete healing: No gingival swelling, redness, suppuration, or patient discomfort; no slough formation. Good healing: Mild gingival swelling or redness, mild patient discomfort, and slough formation without suppuration. Poor healing: Significant gingival swelling or redness, severe patient discomfort, slough formation with suppuration.

Time frame: weekly for 4 weeks postoperatively

Secondary Outcomes

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