Multicenter Randomized Clinical Trial Comparing Apical Flap Repositioning Versus Vestibular Mucosa Excision Associated With Free Gingival Grafts for Peri-Implant Keratinized Mucosa Augmentation
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 46
- 试验地点
- 1
- 主要终点
- Peri-implant keratinized tissue width (KTW) gain
研究概览
简要总结
The goal of this clinical trial is to learn which surgical technique works better to increase the amount of firm gum tissue (called keratinized mucosa) around dental implants in adults.
The main question it aims to answer is:
-Does repositioning the gum flap upward with stitches lead to a greater gain in firm gum tissue width at 6 months compared to simply removing the extra gum tissue, when both techniques are combined with a free gum graft?
Researchers will compare two techniques used during the second stage of implant surgery to see which one produces a greater gain in firm gum tissue around the implant.
Participants will:
- Receive a free gum graft (a small piece of tissue taken from the roof of the mouth) placed around their dental implant during a routine surgical visit
- Be randomly assigned to one of the two surgical techniques
- Have digital scans of their mouth taken at 5 timepoints over 6 months
- Complete a pain diary and answer questions about their experience during the first week after surgery
- Attend follow-up visits at 6 weeks, 3 months, and 6 months after surgery
详细描述
This superiority multicenter randomized clinical trial is coordinated by the Universitat de Barcelona (UB) and includes the Universidad Complutense de Madrid (UCM) as a collaborating center.
Participant selection Adults with osseointegrated implants in the posterior maxilla or mandible presenting keratinized mucosa width of 2 mm or less and/or vestibular depth less than 4 mm will be screened for eligibility. Participants must be in periodontal and peri-implant health and have a plaque index of 15% or less.
Randomization Eligible participants will be randomly assigned (1:1) to one of two treatment groups using an Interactive Web Response System (IWRS) provided by Sealed Envelope Ltd. Randomization will take place intraoperatively, once the partial-thickness mucosal flap has been prepared.
Interventions
Group 1 (Control): Free gingival graft with apical repositioning and suturing of the vestibular mucosal flap to the periosteum Group 2 (Experimental): Free gingival graft with excision of the vestibular mucous tissue
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
Although full masking is not feasible due to the surgical nature of the interventions, the digital analysis of intraoral scan models will be performed by a single calibrated evaluator who will be blinded to group allocation.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men or women aged 18 years or older who voluntarily agree to sign the informed consent form before any study-related procedure is performed.
- •Single or multiple edentulous spaces (≤3 units) located in the posterior maxilla or mandible, presenting osseointegrated implants in first-stage surgery with a -healing period of more than 8 weeks.
- •ASA classification I or II.
- •Periodontal and peri-implant health.
- •O'Leary plaque index ≤15%.
- •Keratinized mucosa width ≤2 mm and/or vestibular depth <4 mm at at least one site.
- •Commitment to attend all follow-up visits over 6 months.
排除标准
- •Systemic diseases that may interfere with performing FGG (free gingival graft), including but not limited to: poorly controlled diabetes mellitus (HbA1c > 8% or per clinical judgment), immunodeficiencies or immunosuppressive treatment, uncontrolled hematological diseases or coagulation disorders, anticoagulant or antiplatelet treatment that cannot be adjusted according to standard clinical practice, active neoplasms under treatment, severe renal or hepatic insufficiency, decompensated cardiovascular diseases, and any other medical condition that, in the investigator's judgment, could compromise participant safety or proper tissue healing.
- •Any contraindication to oral surgical procedures.
- •Periodontal and peri-implant health as defined by the 2017 World Workshop on the Classification of Periodontal and Peri-Implant Diseases and Conditions.
- •Patients who smoke tobacco or equivalent products, as well as former smokers with an abstinence period ≤12 months.
- •History of substance abuse (drugs or alcohol) or any other factor (e.g., severe psychiatric illness) that, in the investigator's opinion, could interfere with the patient's ability to cooperate and comply with the study.
- •Patients who have participated in a clinical trial within the last 30 days.
- •Pregnant or breastfeeding women.
结局指标
主要结局
Peri-implant keratinized tissue width (KTW) gain
时间窗: Baseline (T0) to 6 months (T6m)
Absolute change in KTW, measured digitally as the linear distance between the mucosal margin and the mucogingival junction on the vestibular aspect of the implant, using Geomagic Control X® software on intraoral scan models (TRIOS 3®, 3Shape).
次要结局
- Clinical gain in peri-implant keratinized tissue width (KTW)(Baseline (T0) to 6 months (T6m))
- Change in graft height(Immediate postoperative (Tim), 6 weeks (T6w), 3 months (T3m), 6 months (T6m))
- Change in graft width(Immediate postoperative (Tim), 6 weeks (T6w), 3 months (T3m), 6 months (T6m))
- Graft area contraction(Immediate postoperative (Tim) to 6 months (T6m))
- Change in graft volume(Immediate postoperative (Tim), 6 weeks (T6w), 3 months (T3m), 6 months (T6m))
- Vestibular depth(Baseline (T0) to 6 months (T6m))
- Surgical time(Intraoperative (Tim))
- Adverse events(Immediate postoperative (Tim) to 6 months (T6m))
- Clinician-perceived surgical difficulty(Intraoperative (Tim))
- Postoperative pain(Up to 7 days postoperat)
- Analgesic consumption(Up to 7 days postoperative)
- Patient global satisfaction(7 days postoperative)
- Days with limitation of daily activity(Up to 7 days postoperative)
研究者
Octavi Camps-Font
Associate Professor
University of Barcelona