Liquid fibrin versus soft laser to improve healing and reduce relapse after lip repositioning for gummy smile
Comparison Between The Effect of Liquid Platelet-Rich Fibrin and Low-Level Laser Therapy on Enhancing Healing and Reducing Relapse After Lip Repositioning Surgery
This trial will test whether injecting liquid platelet-rich fibrin or using a low-level laser after lip repositioning helps adults with a gummy smile heal faster and keep results longer.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 22 (estimated) |
| Ages | 18 Years to 50 Years |
| Sex | All |
| Sponsor | Damascus University Academic / other |
| Locations | 1 site (Damascus, Rif-dimashq Governorate) |
| Trial ID | NCT07532161 on ClinicalTrials.gov |
What this trial studies
Lip repositioning surgery reduces excessive gingival display but can be complicated by pain, swelling, delayed healing, and postoperative relapse. In this single-center interventional trial at Damascus University, patients with a gummy smile due to hyperactive upper lip will undergo lip repositioning and be assigned to receive either injectable liquid platelet-rich fibrin (i-PRF) or low-level soft laser therapy as an adjunct. The study will track wound healing, pain and swelling, and the degree of gingival display relapse over follow-up visits. The two adjunctive approaches will be compared to determine which better supports tissue healing and stability of the surgical result.
Who should consider this trial
Good fit: Adults aged 18–50 who are systemically healthy, maintain good oral hygiene, have a gummy smile (>3 mm) due to upper lip hypermobility, and have not had prior lip repositioning are ideal candidates.
Not a fit: Patients with gummy smile primarily from skeletal causes (e.g., vertical maxillary excess), smokers, pregnant or lactating individuals, those with prior facial Botox or fillers, people with systemic contraindications to local anesthesia, or those with poor oral hygiene are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, the intervention could speed healing, reduce postoperative pain and swelling, and lower the chance of relapse, producing longer-lasting esthetic results.
How similar studies have performed: Platelet-rich fibrin and low-level laser have shown benefits for wound healing in other oral and soft-tissue procedures, but evidence specifically showing reduced relapse after lip repositioning is limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Damascus, Rif-dimashq Governorate
- Faculty of Dentistry, Damascus university , Syria. — Damascus, Rif-dimashq Governorate, Syria (Recruiting)
Study contacts
- Study coordinator: Tarek Qasem, DDS MSc PhD
- Email: Tarek2.qasem@damascusuniversity.edu.sy
- Phone: +963 933432778
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.