Clinical, Radiographic, and Digital Evaluation of the Effects of Autogenous Grafts Harvested From Different Palatal Sites and Applied During Second-stage Implant Surgery on the Peri-implant Mucosa
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Peri-implant Mucosal Thickness
研究概览
简要总结
This study aims to evaluate the effects of autogenous grafts harvested from different palatal regions on the peri-implant mucosa when applied during second-stage dental implant surgery.
Clinical, radiographic, and digital assessment methods will be used to investigate the early effects of these grafts on peri-implant mucosal width and thickness. In addition, peri-implant tissue health and patient-reported outcomes will be evaluated to compare the effectiveness of the grafting techniques in peri-implant soft tissue management.
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
- Double (Investigator, Outcomes Assessor)
盲法说明
Single blinded
入排标准
- 年龄范围
- 18 Months 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age over 18 years
- •Systemically healthy patients
- •Presence of premolar or molar tooth loss in the mandible
- •Adequate mesiodistal and interocclusal space for implant and restoration placement
- •At least four months elapsed since tooth extraction
- •Alveolar bone width of at least 6 mm and sufficient alveolar bone height to allow implant placement without compromising anatomical structures
- •Full-mouth plaque and bleeding scores less than 20%
- •Presence of opposing teeth in occlusion
- •Keratinized mucosa width in the relevant region less than 2 mm
- •Keratinized mucosa thickness in the relevant region of 2 mm or less
- •Presence of a healthy second premolar in the maxilla
- •Provision of written informed consent and permission for the use of data for research purposes
排除标准
- •Poor oral hygiene
- •Uncontrolled periodontal disease
- •Pregnancy or lactation at any stage of the study
- •Uncontrolled diabetes mellitus
- •Immunocompromised patients
- •Previous radiotherapy to the head and neck region
- •Diseases or medications affecting bone metabolism
- •Antibiotic use within the three months prior to the procedure
- •Smoking more than 10 cigarettes per day
- •Pre- or simultaneous bone augmentation prior to implant placement
- •Lack of primary stability at the time of implant placement
研究组 & 干预措施
Coronal palatal tissue
Participants in this group will receive grafts including marginal and interdental palatal gingiva.
干预措施: Coronal palatal tissue (Procedure)
Apical palatal tissue
Participants in this group will receive grafts harvested from approximately 1.5 mm apical to the palatal gingival margin.
干预措施: Apical palatal tissue (Procedure)
结局指标
主要结局
Peri-implant Mucosal Thickness
时间窗: Pre-operative and post-operative (before implant placement, 3rd month (second-stage implant surgery), 6th month after implant placement, and 12th month after prosthetic loading)
The primary outcome is the change in peri-implant mucosal thickness measured at four time points using clinical and digital methods.
次要结局
- Keratinized Mucosa Width(Pre-operative and post-operative (before implant placement, 3rd month (second-stage implant surgery), 6th month after implant placement, and 12th month after prosthetic loading))
- Vestibular Depth(Pre-operative and post-operative (before implant placement, 3rd month (second-stage implant surgery), 6th month after implant placement, and 12th month after prosthetic loading))
- Modified Plaque Index(Postoperative 6th month after implant placement and 12th month after prosthetic loading)
- Modified Bleeding Index(Postoperative 6th month after implant placement and 12th month after prosthetic loading)
- Peri- implant Probing Depth(Postoperative 6th month after implant placement and 12th month after prosthetic loading)
- Mucosal Recession(12th month after prosthetic loading)
- Marginal Bone Level(Pre-operative and post-operative (before implant placement, 3rd month (second-stage implant surgery), 6th month after implant placement, and 12th month after prosthetic loading))
- Pink Esthetic Score (PES)(Postoperative 3rd month (second-stage implant surgery) and 12th month after prosthetic loading)
- Postoperative Pain Assessment(Postoperative 14 days (daily after graft application))
- Analgesic Consumption(Postoperative 14.days (after graft application))
- Patient Satisfaction(Postoperative 14.days (after graft application))
- Patient-Perceived Esthetic Outcome(12th month after prosthetic loading)
- Oral Health-Related Quality of Life(Postoperative 3rd month (second-stage implant surgery) and 12th month after prosthetic loading)
研究者
Ezgi Gürbüz
Associate Professor
Kutahya Health Sciences University