Keratinized Tissue Augmentation Using Porcine Collagen Matrix (Mucoderm®) Around Dental Implant: A Randomized Clinical Study
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 22
- 试验地点
- 3
- 主要终点
- Keratinized mucosa width
研究概览
简要总结
Aim of the Study To evaluate the using of porcine collagen matrix for keratinized tissue augmentation around delayed dental implant.
Primary Outcome:
Peri-implant keratinized mucosal width and thickness following the use of porcine collagen matrix using (Mucoderm®-Botiss gmbh) compared to the gold standard FGG augmentation.
Secondary Outcome:
- Crestal bone change (CBC)
- Pocket depth (PD)
- Bleeding on probing (BOP)
- Plaque index (PI) PICOT
P: Population:
Patient with suitable ridge dimension for delayed implant placement.
I: Intervention:
Implant insertion followed by porcine collagen matrix soft tissue augmentation
C: Control:
Autogenous FGG
O: Outcomes
- Enhancing keratinized mucosal width and thickness
- Evaluating :
- Crestal bone change (CBC)
- perimplant Pocket depth (PD)
- Bleeding on probing (BOP)
- Plaque index (PI)
- Modified PES. T: Time A 6 months follow up .
详细描述
this study aiming to augment KMW with FGG and MUCODERM following apically positioned flap the primary outcomes to measure is KMW and MT
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 (Investigator)
入排标准
- 年龄范围
- 20 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •1- Partially or fully edentulous sites with previous implant placed in posterior maxillary or mandibular areas.
- •2- Inadequate keratinized tissue ≤2 3- Patient age ranged from 20 to 45 years old for both genders. 4- Submerged Osteointegrated implants with no sings of inflammation before implant insertion.
- •5- Optimal compliance as evidenced by no missed treatment appointments and positive attitude toward oral hygiene.
排除标准
- •1- Smokers 2- Pregnant or lactating female 3- Treatment with any systemic drug that could affect wound healing (ex- corticosteroids ) 4- History of systemic disease affect wound healing ex diabetes 5- Patient with bruxism and parafunctional habits. 6- Limited inter arch restoration space.
结局指标
主要结局
Keratinized mucosa width
时间窗: 1 month , 3 month , 6 months follow up
before the operation reading , immediately after operation , 1 month follow up , 3 months follow up and 6 months follow up the reading will done using periodontal probe
keratinized tissue thickness
时间窗: 1 month , 3 month , 6 months follow up
measures the Keratinized tissue thickness using periodontal probe
次要结局
- probing depth for adjacent teeth(6 months)
- bleeding on probingn(1 month , 3 month , 6 months follow up)
- crestal bone loss around dental implant(1 month , 3 month , 6 months follow up)
研究者
ahmed amer
teaching assistant periodontics department faculty of dentistry
Misr University for Science and Technology