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Gummy SmileNCT07532161

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

A study testing Liquid Platelet-Rich Fibrin group and low-level laser group in people with Gummy Smile, run by Damascus University at 1 site in Syria.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 18 to 50 years
Conditions the study is for
Gummy Smile
What is being tested?
Liquid Platelet-Rich Fibrin group and low-level laser group
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
22 participants
Where
1 siteSyria
Study dates
20 Apr 2026to 31 Jan 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 50 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 10Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Syria1 site, 1 recruiting
  • Faculty of Dentistry, Damascus university , Syria.

    Damascus, Rif-dimashq Governorate

    Mohammad Younis Hajeer, DDS MSc PhD, +963 940404840, myhajeer@gmail.com

    Walaa albarry, DDS

    Recruiting

Other trials in Syria

About this study

Official 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

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).

Conditions
Gummy Smile
Being tested
Liquid Platelet-Rich Fibrin group, low-level laser group
Keywords
Excessive gingival display, Gummy smile, Lip Repositioning Surgery, Injectable Platelet-Rich Fibrin (i-PRF), Liquid Platelet-Rich Fibrin, Low-Level Laser Therapy (LLLT), Wound healing, Postoperative relapse, Gingival display reduction, Esthetic dentistry

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Liquid Platelet-Rich Fibrin 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 ; 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.

Study groups in NCT07532161
Study groupRoleWhat they receive
Liquid Platelet-Rich Fibrin groupExperimentalThis 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.
Receives: Other: Liquid Platelet-Rich Fibrin group
Low-Level Laser groupExperimentalThis 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.
Receives: Other: low-level laser group

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Baseline and 1, 3 and 6 months postoperatively

  2. 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.

    Measured: weekly for 4 weeks postoperatively

Secondary outcomes (7)
  1. 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.

    Measured: Days 1-7 postoperatively

  2. 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

    Measured: Day 3 postoperatively

  3. 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.

    Measured: 6 months postoperatively

  4. 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

    Measured: Baseline, 1,3 and 6 months postoperatively

  5. Upper Lip Internal Length

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

    Measured: Baseline, 1, 3 and 6 months postoperatively

  6. 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.

    Measured: During surgery

  7. 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.

    Measured: First week postoperatively

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Apr 2026
  2. Study start20 Apr 2026
  3. Primary completion31 Jan 2027 (estimated)
  4. Study completion31 Jan 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
22 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07532161
Sponsor's protocol ID
UDDS-Perio-2026-02
Status last verified
Apr 2026
First submitted
9 Apr 2026
Last updated
29 Apr 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Miron RJ, Gruber R, Farshidfar N, Sculean A, Zhang Y. Ten years of injectable platelet-rich fibrin. Periodontol 2000. 2024 Feb;94(1):92-113. doi: 10.1111/prd.12538. Epub 2023 Nov 30.

    PubMed 38037213
  • Alammar A, Heshmeh O, Mounajjed R, Goodson M, Hamadah O. A comparison between modified and conventional surgical techniques for surgical lip repositioning in the management of the gummy smile. J Esthet Restor Dent. 2018 Nov;30(6):523-531. doi: 10.1111/jerd.12433. Epub 2018 Nov 9.

    PubMed 30412347
  • Farshidfar N, Amiri MA, Estrin NE, Ahmad P, Sculean A, Zhang Y, Miron RJ. Platelet-rich plasma (PRP) versus injectable platelet-rich fibrin (i-PRF): A systematic review across all fields of medicine. Periodontol 2000. 2025 Oct;99(1):185-215. doi: 10.1111/prd.12626. Epub 2025 Mar 24.

    PubMed 40125556
  • Sun G, Tuner J. Low-level laser therapy in dentistry. Dent Clin North Am. 2004 Oct;48(4):1061-76, viii. doi: 10.1016/j.cden.2004.05.004.

    PubMed 15464564
  • Tawfik OK, El-Nahass HE, Shipman P, Looney SW, Cutler CW, Brunner M. Lip repositioning for the treatment of excess gingival display: A systematic review. J Esthet Restor Dent. 2018 Mar;30(2):101-112. doi: 10.1111/jerd.12352. Epub 2017 Nov 27.

    PubMed 29193632
  • AlJasser RN. A Modified Approach in Lip Repositioning Surgery for Excessive Gingival Display to Minimize Post-Surgical Relapse: A Randomized Controlled Clinical Trial. Diagnostics (Basel). 2023 Feb 14;13(4):716. doi: 10.3390/diagnostics13040716.

    PubMed 36832213
  • Tjan AH, Miller GD, The JG. Some esthetic factors in a smile. J Prosthet Dent. 1984 Jan;51(1):24-8. doi: 10.1016/s0022-3913(84)80097-9.

    PubMed 6583388
  • Robbins JW. Differential diagnosis and treatment of excess gingival display. Pract Periodontics Aesthet Dent. 1999 Mar;11(2):265-72; quiz 273.

    PubMed 10321231

Questions about this trial

What is this clinical trial studying?

A study testing Liquid Platelet-Rich Fibrin group and low-level laser group in people with Gummy Smile, run by Damascus University at 1 site in Syria.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 29 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Syria. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Tarek Qasem, DDS MSc PhD (+963 933432778, Tarek2.qasem@damascusuniversity.edu.sy), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Gingival display (mm) (time frame: Baseline and 1, 3 and 6 months postoperatively). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07532161, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2026.

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