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.
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
- 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
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 group | Role | What they receive |
|---|---|---|
| Liquid Platelet-Rich Fibrin group | Experimental | 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. Receives: Other: Liquid Platelet-Rich Fibrin group |
| Low-Level Laser group | Experimental | 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. Receives: Other: low-level laser group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
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:
- = 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.
Measured: weekly for 4 weeks postoperatively
Secondary outcomes (7)
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
Postoperative Edema/Swelling
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
Measured: 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.
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
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.
- First posted15 Apr 2026
- Study start20 Apr 2026
- Primary completion31 Jan 2027 (estimated)
- Study completion31 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Gummy SmileStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Damascus University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tarek Qasem, DDS MSc PhD, Study director, Faculty of Dentistry, Damascus university, Syria.
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 38037213Alammar 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 30412347Farshidfar 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 40125556Sun 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 15464564Tawfik 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 29193632AlJasser 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 36832213Tjan 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 6583388Robbins JW. Differential diagnosis and treatment of excess gingival display. Pract Periodontics Aesthet Dent. 1999 Mar;11(2):265-72; quiz 273.
PubMed 10321231
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07532161
- Acronym / sponsor ID
- UDDS-Perio-2026-02
- Conditions
- Gummy Smile
- 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
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 22 participants (estimated)
- Lead sponsor
- Damascus UniversityUniversity, hospital or other
- Study start
- 20 Apr 2026 (actual)
- Primary completion
- 31 Jan 2027 (estimated)
- Study completion
- 31 Jan 2027 (estimated)
- First posted
- 15 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Liquid Platelet-Rich Fibrin group | Experimental | Other: Liquid Platelet-Rich Fibrin groupThis 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. |
| Low-Level Laser group | Experimental | Other: low-level laser groupThis 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. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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%.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Liquid Platelet-Rich Fibrin groupA 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. | Other | Liquid Platelet-Rich Fibrin group |
| low-level laser groupA 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. | Other | Low-Level Laser group |
Primary outcome
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.
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: 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.
7 secondary outcomes
Postoperative Pain (VAS 0-100)
Time frame: Days 1-7 postoperatively
Postoperative Edema/Swelling
Time frame: Day 3 postoperatively
Esthetic Satisfaction (VAS 0-100)
Time frame: 6 months postoperatively
Upper Lip External Length
Time frame: Baseline, 1,3 and 6 months postoperatively
Upper Lip Internal Length
Time frame: Baseline, 1, 3 and 6 months postoperatively
Intraoperative complications
Time frame: During surgery
Post-operative complications
Time frame: First week postoperatively
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2026.
- Background: PubMed 38037213Miron 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.
- Background: PubMed 30412347Alammar 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.
- Background: PubMed 40125556Farshidfar 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.
- Background: PubMed 15464564Sun 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.
- Background: PubMed 29193632Tawfik 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.
- Background: PubMed 36832213AlJasser 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.
- Background: PubMed 6583388Tjan 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.
- Background: PubMed 10321231Robbins JW. Differential diagnosis and treatment of excess gingival display. Pract Periodontics Aesthet Dent. 1999 Mar;11(2):265-72; quiz 273.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Tarek Qasem, DDS MSc PhD study director
Faculty of Dentistry, Damascus university, Syria.
1 site in 1 country: see every site and its status.
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.