Comparison Between The Effect of Liquid Platelet-Rich Fibrin and Low-Level Laser Therapy on Enhancing Healing and Reducing Relapse After Lip Repositioning Surgery
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- Gingival display (mm)
研究概览
简要总结
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Randomized comparative clinical trial with blinded outcome assessment. Outcome assessment was performed by an independent examiner who was blinded to the treatment allocation. Clinical photographs and clinical measurements were coded and evaluated without revealing the group assignment. Statistical analysis was performed using coded data to ensure blinding of the data analyst.
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Liquid Platelet-Rich Fibrin group (Other)
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.
干预措施: low-level laser group (Other)
结局指标
主要结局
Gingival display (mm)
时间窗: 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
时间窗: 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.
次要结局
- Postoperative Pain (VAS 0-100)(Days 1-7 postoperatively)
- Postoperative Edema/Swelling(Day 3 postoperatively)
- Esthetic Satisfaction (VAS 0-100)(6 months postoperatively)
- Upper Lip External Length(Baseline, 1,3 and 6 months postoperatively)
- Upper Lip Internal Length(Baseline, 1, 3 and 6 months postoperatively)
- Intraoperative complications(During surgery)
- Post-operative complications(First week postoperatively)