Clinical Effectiveness of Combining Free Gingival Strip Graft With Platelet-Rich Fibrin for Peri-Implant Keratinized Mucosa Augmentation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- Assessment of the increase in peri-implant keratinized mucosa width
研究概览
简要总结
This clinical trial aims to evaluate the clinical effectiveness of combining a strip free gingival graft (sFGG) with Platelet-Rich Fibrin (PRF) for increasing keratinized mucosa around dental implants. The study compares this combined technique with the conventional free gingival graft (FGG) method through three primary objectives:
- comparing the increase in keratinized mucosal height at immediate post-op, 1, 3, and 6 months;
- assessing post-operative pain levels at 1, 3, 7, and 14 days;
- evaluating soft tissue aesthetic outcomes at 6 months post-surgery.
详细描述
Pre-operative phase:
Eligible patients undergo clinical examination and medical record documentation. Written informed consent is obtained prior to enrollment. Participants are randomly assigned by drawing one of 22 sealed envelopes: odd numbers are allocated to Group A (strip free gingival graft with PRF) and even numbers to Group B (conventional free gingival graft). Baseline intraoral and extraoral photographs and intraoral scans (PLY format) are obtained.
Intra-operative phase:
- Group A (Experimental): PRF is prepared from venous blood. A strip free gingival graft is harvested from the palate and placed at the recipient site in combination with PRF.
- Group B (Control): A conventional free gingival graft is harvested from the palate and placed at the recipient site.
Post-operative phase:
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
The outcomes are evaluated by an independent assessor who is blinded to treatment allocation (the assessor does not know which group the patient being evaluated belongs to).
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients meeting the following criteria are eligible for the study:
- •Prosthetic Phase: Patients scheduled for the prosthetic phase of dental implant treatment.
- •Keratinized Mucosa: Keratinized mucosa height (buccal or lingual) of less than 2 mm around the implant.
- •Systemic Health: Systemic health status classified as ASA I or II according to the American Society of Anesthesiologists classification.
- •Oral Hygiene: Good oral hygiene, defined by a mean full-mouth plaque index (PlI) of ≤ 1.
排除标准
- •Patients meeting any of the following criteria will be excluded from the study:
- •Systemic Conditions: Presence of systemic diseases or use of medications known to affect the oral mucosa or gingival health.
- •Periodontal Health: Untreated periodontal disease and/or peri-implant diseases.
- •Surgical History: History of mucogingival surgery at the intended surgical site.
- •Pregnancy/Lactation: Pregnant or breastfeeding women.
- •Oral Hygiene: Poor oral hygiene, defined by a mean full-mouth plaque index (PlI) >
- •Smoking: Current smokers.
研究组 & 干预措施
Conventional Free Gingival Graft (FGG)
A surgical procedure where a graft consisting of epithelium and connective tissue is harvested from the palate and transplanted to the peri-implant area to increase the width and height of keratinized mucosa
干预措施: Conventional Free Gingival Graft (FGG) to increase keratinized mucosa around dental implants (Procedure)
Combining a strip free gingival graft with Platelet-Rich Fibrin (PRF) to increase keratinized mucosa
Venous blood is collected using a butterfly needle and 10ml tubes to prepare the PRF membrane. A keratinized mucosa strip of appropriate dimensions is harvested from the patient's palate. The strip free gingival graft and PRF membrane are then sutured and stabilized at the recipient site.
干预措施: Combining a strip free gingival graft (sFGG) with Platelet-Rich Fibrin (PRF) to increase keratinized mucosa around dental implants (Procedure)
结局指标
主要结局
Assessment of the increase in peri-implant keratinized mucosa width
时间窗: 1, 3, 6 months
KMW was assessed at the mid-buccal aspect of each implant, measuring the distance from the MGJ to the mucosal margin/alveolar zenith using STL surface data at 1, 3, and 6 months.
Assessment of the increase in peri-implant keratinized mucosa width and mucosa thickness
时间窗: 1, 3, 6 months
KMW and MT were assessed using STL surface data at 1, 3, and 6 months
Soft tissue esthetics assessed by the modified Pink Esthetic Score (PES)
时间窗: 6 months post-operatively
"The esthetic outcome of the peri-implant soft tissue is evaluated using the modified Pink Esthetic Score (PES) as described by Fürhauser et al. (2005). The assessment compares the grafted area to the adjacent natural tooth based on parameters: Soft tissue color difference, soft tissue texture difference, soft tissue contour difference. Each parameter is assigned a score of 0, 1, or 2 (0 being the lowest, 2 being the highest/most esthetic). The total PES score ranges from 0 to 6, where a higher score indicates a superior esthetic result
Assessment of the increase in peri-implant keratinized mucosa width
时间窗: 1, 4, 6 months
KMW was assessed at the mid-buccal aspect of each implant, measuring the distance from the MGJ to the mucosal margin/alveolar zenith using STL surface data at 1, 4, and 6 months.
Soft tissue esthetics assessed by the modified Pink Esthetic Score (PES)
时间窗: 4 months and 6 months post-operatively
"The esthetic outcome of the peri-implant soft tissue is evaluated using the modified Pink Esthetic Score (PES) as described by Fürhauser et al. (2005). The assessment compares the grafted area to the adjacent natural tooth based on seven parameters: Soft tissue color difference, soft tissue texture difference, grafted site margins-mesial side, distal side, level of mucogingival junction, keloid-like appearance. Each parameter is assigned a score of 0, 1, or 2 (0 being the lowest, 2 being the highest/most esthetic). The total PES score ranges from 0 to 14, where a higher score indicates a superior esthetic result
Post-operative pain intensity measured by Visual Analog Scale (VAS)
时间窗: 1, 3, 7 and 14 days post-operatively
Pain intensity is measured on a Visual Analog Scale from 0 (no pain) to 10 (unbearable pain). Participants will be asked to mark their level of discomfort at each time point.
次要结局
未报告次要终点
研究者
Nguyen Van Khuong
Doctor
University of Medicine and Pharmacy at Ho Chi Minh City