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NCT Number: NCT07532161

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

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).

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Key information

Conditions

Gummy Smile

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Dentistry, Damascus university , Syria.

Damascus, Rif-dimashq Governorate, Syria

Location status: Recruiting

Location contact

Mohammad Younis Hajeer, DDS MSc PhD

CONTACT

[email protected]

+963 940404840

Walaa albarry, DDS

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients of both genders.
  • Patients presenting with a gummy smile in the maxillary anterior region (more than 3 mm) due to upper lip hypermobility.
  • Age 18-50 years.
  • 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.
  • Patients with good oral hygiene, defined as an O'Leary Plaque Index ≤ 40%.
  • No previous lip repositioning surgery.

Exclusion criteria

  • Pregnancy and lactation.
  • Individuals with a previous history of receiving facial Botox or filler injections.
  • Systemic diseases or conditions that contraindicate the use of local anesthesia.
  • Any physical condition that impairs the ability to perform proper oral hygiene measures.
  • Patients who are smokers or alcohol consumers.
  • Inability or unwillingness to cooperate.
  • In adequate width of attached gingiva.
  • Vertical maxillary excess (moderate to severe) requiring orthognathic intervention.
  • Short upper lip
  • Gingival display primarily caused by altered passive eruption requiring crown lengthening.

Treatment and study plan

Liquid Platelet-Rich Fibrin group

Other

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 group

Other

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.

Primary outcomes

  1. Gingival display (mm)

    Time frame: Baseline and 1, 3 and 6 months postoperatively

    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.

  2. Wound Healing Index

    Time frame: weekly for 4 weeks postoperatively

    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:

    • = poor healing (significant gingival swelling or redness, severe patient discomfort, slough formation with suppuration);
    • = good healing (mild gingival swelling or redness, mild patient discomfort, slough formation without suppuration);
    • = complete healing (no gingival swelling, redness, suppuration, or patient discomfort, and no slough formation).

    Higher scores indicate better healing outcomes.

Secondary outcomes

  1. Postoperative Pain (VAS 0-100)

    Time frame: Days 1-7 postoperatively

    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.

  2. Postoperative Edema/Swelling

    Time frame: Day 3 postoperatively

    Postoperative edema/swelling assessed on the third day after surgery using a clinician-reported rating scale: 0 = no visible oedema;

    • = slight oedema (intra- oral swelling in the surgical zone);
    • = moderate oedema (extra- oral swelling in the surgical area);
    • = severe oedema (extra- oral swelling extending the surgical site) and/or visible hematoma and ecchymosis

  3. Esthetic Satisfaction (VAS 0-100)

    Time frame: 6 months postoperatively

    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.

  4. Upper Lip External Length

    Time frame: Baseline, 1,3 and 6 months postoperatively

    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

  5. Upper Lip Internal Length

    Time frame: Baseline, 1, 3 and 6 months postoperatively

    Measured at rest and smile to assess the dimensions of the internal upper lip

  6. Intraoperative complications

    Time frame: During surgery

    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.

  7. Post-operative complications

    Time frame: First week postoperatively

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Tarek Qasem, DDS MSc PhD

CONTACT

[email protected]

+963 933432778

Walaa albarry, DDS

CONTACT

[email protected]

+963 996766302

Sponsors and collaborators

Lead sponsor

Damascus University

Other

Registry information

Official study title

Comparison Between The Effect of Liquid Platelet-Rich Fibrin and Low-Level Laser Therapy on Enhancing Healing and Reducing Relapse After Lip Repositioning Surgery

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Apr 15, 2026
Registry last updated
Apr 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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