Comparative evaluation of peri-implant mucosal enhancement with and without concentrated growth factor membrane at different stages of implant placement – an interventional study.
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 27
- 试验地点
- 1
- 主要终点
- 1. Thickness of Peri-Implant Mucosa
研究概览
简要总结
**SUMMARY:**Rationale/gaps in existing knowledge: The long-term success of dental implants is significantly influenced by the thickness of the peri-implant mucosa. Inadequate mucosal thickness can predispose the implant site to complications such as peri-implantitis and compromise aesthetic outcomes. While Concentrated Growth Factors (CGF) have demonstrated regenerative properties in various dental procedures, their specific role in enhancing peri-implant mucosal thickness at different stages of implant placement has not been thoroughly investigated, indicating a gap in current clinical knowledge.
Novelty: This study introduces a novel approach by evaluating the effectiveness of a CGF membrane in improving both peri-implant mucosal thickness and the width of keratinized mucosa. It also uniquely compares the impact of CGF application when administered at different stages of implant placement, thereby aiming to identify the most beneficial timing for CGF use.
Objectives: The study aims to assess and compare clinical parameters, specifically mucosal thickness and the width of keratinized mucosa, among three distinct groups at baseline, four weeks, and three months. The objective is to evaluate the changes and improvements in these parameters over time following CGF application.
Methods: This is an interventional clinical study involving three groups. The first group serves as the control, receiving no CGF application. The second group receives CGF at the time of Stage 1 implant placement, while the third group receives CGF during Stage 2 implant placement. Measurements of peri-implant mucosal thickness and width of keratinized mucosa will be recorded at baseline, four weeks, and three months to monitor the progression and effects of the intervention.
Expected outcome: It is anticipated that the application of CGF will lead to a measurable enhancement in peri-implant mucosal thickness, with one particular stage of application showing superior outcomes. The findings are expected to offer valuable insights into the optimal timing of CGF application for improving peri-implant soft tissue outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Systemically healthy patients with no history of uncontrolled medical conditions (e.g., uncontrolled diabetes, cardiovascular disease).
- •Participants aged 18-65 years.
- •Need for one or more dental implants in the mandibular posterior region.
- •Participants with peri-implant mucosal thickness of 1.5mm – 2.5mm.
- •Participants with NO ongoing periodontal disease.
- •Presence of stable occlusion(bite).
- •Sufficient bone volume and quality to support the implant based on radiographs.
- •Ability to understand and comply with study procedures, including follow-up visits.
排除标准
- •Participants with uncontrolled systemic conditions, such as uncontrolled diabetes, cardiovascular diseases, autoimmune disorders, or bleeding disorders. 2) Severe bone loss.
- •Insufficient bone width or height for implant placement or presence of advanced bone atrophy. 3) Use of medications like systemic corticosteroids, immunosuppressants, or bisphosphonates that could impair healing or affect CGF efficacy. 4) History of radiotherapy in the head/neck area or chemotherapy within the last 12 months. 5) Participants who are unable to follow post-operative care instructions or attend follow-up visits. 6) Any ongoing periodontal infection. 7) Pregnant or breastfeeding women. 8) Known allergies to materials used in implant dentistry. 9) Previous implant failures or complications.
结局指标
主要结局
1. Thickness of Peri-Implant Mucosa
时间窗: Baseline, 4 Weeks and 3 Months
次要结局
- 1. Width of Keratinized Tissue(2. Healing Progression)