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

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

Overview

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).

Interventions

• Other Liquid Platelet-Rich Fibrin group
  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 appr
• Other low-level laser group
  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 a

Primary outcome measures

• Gingival display (mm) [Time frame: Baseline and 1, 3 and 6 months postoperatively]
• Wound Healing Index [Time frame: weekly for 4 weeks postoperatively]

Secondary outcome measures (7)

• 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]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

Syria · 1 center

• Faculty of Dentistry, Damascus university , Syria. — Damascus

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. PMID 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. PMID 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 Mar 24. doi: 10.1111/prd.12626. Online ahead of print. PMID 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. PMID 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. PMID 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. PMID 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. PMID 6583388
• Robbins JW. Differential diagnosis and treatment of excess gingival display. Pract Periodontics Aesthet Dent. 1999 Mar;11(2):265-72; quiz 273. PMID 10321231

Identifiers

NCT: NCT07532161 · UDDS-Perio-2026-02

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗