- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07532161
Comparison Between Liquid Fibrin and Soft Laser Effects on Healing and Relapse After Lip Repositioning Surgery
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).
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Tarek Qasem, DDS MSc PhD
- Phone Number: +963 933432778
- Email: Tarek2.qasem@damascusuniversity.edu.sy
Study Contact Backup
- Name: Walaa albarry, DDS
- Phone Number: +963 996766302
- Email: walaa9.albarry.@damascusuniversity.edu.sy
Study Locations
-
-
Rif-dimashq Governorate
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Damascus, Rif-dimashq Governorate, Syria
- Recruiting
- Faculty of Dentistry, Damascus university , Syria.
-
Contact:
- Mohammad Younis Hajeer, DDS MSc PhD
- Phone Number: +963 940404840
- Email: myhajeer@gmail.com
-
Principal Investigator:
- Walaa albarry, DDS
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 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 injection of Liquid Platelet-Rich Fibrin after completion of the surgical procedure.
|
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. |
|
Experimental: Low-Level Laser 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.
|
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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
Baseline and 1, 3 and 6 months postoperatively
|
|
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:
Higher scores indicate better healing outcomes. |
weekly for 4 weeks postoperatively
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
Days 1-7 postoperatively
|
|
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;
|
Day 3 postoperatively
|
|
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.
|
6 months postoperatively
|
|
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
|
Baseline, 1,3 and 6 months postoperatively
|
|
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
|
Baseline, 1, 3 and 6 months postoperatively
|
|
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.
|
During surgery
|
|
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.
|
First week postoperatively
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Tarek Qasem, DDS MSc PhD, Faculty of Dentistry, Damascus university, Syria.
Publications and helpful links
General 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.
- 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.
- 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 Mar 24. doi: 10.1111/prd.12626. Online ahead of print.
- 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.
- 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.
- 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.
- 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.
- Robbins JW. Differential diagnosis and treatment of excess gingival display. Pract Periodontics Aesthet Dent. 1999 Mar;11(2):265-72; quiz 273.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- UDDS-Perio-2026-02
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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