“Comparative evaluation of the peri-implant soft tissue phenotype with and without the use of porcine-derived acellular dermal matrix” – A randomised control trial.
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- increased peri-implant soft tissue thickness and width of keratinized mucosa
研究概览
简要总结
Dental implants are a reliable long-term solution for tooth replacement, with survival rates exceeding 95% over ten years (1). Beyond function, implants play a crucial role in preserving bone and soft tissue integrity. Achieving aesthetic and functional success requires proper implant positioning and meticulous soft tissue management, as emphasized by Dr. Dennis Tarnow: “The best implant is the one that looks like it was never placed.”
While peri-implant bone stability is well-documented, Emerging evidence highlights the importance of soft tissue thickness in implant longevity (2). Berglundh and Lindhe demonstrated that adequate soft tissue thickness is necessary for forming biological structures akin to natural teeth. Linkevicius et. al found that an alveolar mucosa thickness >2 mm significantly reduces peri-implant bone loss within the first year (3-4). Insufficient keratinized mucosa (<2 mm) is associated with increased probing depth, bleeding, and plaque accumulation, whereas adequate keratinized mucosa enhances plaque control and peri-implant health. (5-10)
| Traditional augmentation techniques like subepithelial connective tissue grafts (SCTG) and free gingival grafts (FGG) are effective but pose challenges such as patient morbidity and donor site limitations (11-14). As an alternative to SCTG, the porcine acellular dermal matrix, composed of collagen types I and III, has been proposed. Studies have demonstrated its excellent biodegradation properties within the surrounding tissues. |
Acellular Dermal Matrix (ADM), is a widely used xenograft material that supports revascularization, cell repopulation, and tissue remodelling. Its advantages include an unlimited supply, the elimination of the need for a secondary palatal surgical site and decreased intraoperative time. ADM facilitates soft tissue augmentation by providing an extracellular matrix that promotes cellular migration and revascularization. Studies suggest ADM can mimic the native tissue microenvironment and provide structural stability. Clinical trials have shown that ADM achieves comparable outcomes to Connective Tissue Grafts (CTG) in root coverage and reducing recession depth and width. It has been successfully applied to enhance natural soft tissue around teeth. (15-18).
The present study will be comparing peri-implant soft tissue phenotype with and without ADM. Patients will be randomly assigned to a control group (Group I- implant with healing abutment) and a test group (Group II-Implant with ADM and healing abutment).
· Expected outcomes- includes improved peri-implant health and longevity in the ADM group. This study addresses a critical gap in peri-implant tissue management and has the potential to redefine soft tissue augmentation protocols, improving clinical outcomes while minimizing patient morbidity.
研究设计
- 研究类型
- Interventional
- 分配方式
- Stratified block randomization
- 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
- •1.periodontaly healthy or with stable treated periodontitis and good oral hygiene(full mouth plaque score and full mouth bleeding score less than or equal to 10%)
- •need for one or two implants in the posterior region (maximum of three missing teeth).
- •enough bone avilability to place an implant with a minimum diameter of 3.8 to 4.2 mm and atleast 10mm length.
- •ability to understand the study procedures and to comply with them to the entire length of the study.
排除标准
- •1.subjectes taking medications with immunosuppressors, bisphosphonates or high doses of corticosteroids; current drug or alcohol use or dependence that could interfere with adherence to study requirements.
- •2.pregnant or lactating women.
- •3.history of cancer requiring radiotherapy or chemotherapy during the last 5 years.
- •4.local inflammation (including untreated periodontitis) 5.severe bruxism or clenching habits.
- •6.any kind of bone augmentation performed on the implant site, with a healing period less than 6 months.
- •7.lack of primary implant stability assessed intra surgically.
结局指标
主要结局
increased peri-implant soft tissue thickness and width of keratinized mucosa
时间窗: baseline, 1month, 3months, 6months, 9months.
次要结局
- improved peri-implant soft tissue health and aesthetics. also longevity of implant(baseline, 1month, 3months, 6months, 9months.)