Impact of Keratinized Mucosa Augmentation Following Non-surgical Therapy on Treatment Outcomes of Peri-implant Mucositis.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Inflammatory parameter levels in peri-implant crevicular fluid
研究概览
简要总结
This study aims to observe the effects of keratinized mucosa width on peri-implant tissues by evaluating clinical and biochemical parameters. The main question it aims to answer is:
Would increasing the width of the keratinized mucosa with free gingival graft (FGG) in peri-implant mucositis be beneficial in terms of clinical periodontal parameters and peri-implant crevicular fluid levels of inflammatory cytokines compared to non-surgical therapy alone?
Our study consists of 4 groups:
Peri-implant healthy group with sufficient keratinized mucosa (≥ 2mm) (n=16), peri-implant mucositis group with sufficient keratinized mucosa (n=16), peri-implant mucositis group with insufficient keratinized mucosa (< 2mm) receiving only non-surgical treatment (n=16), peri-implant mucositis group with insufficient keratinized mucosa receiving FGG in addition to non-surgical treatment (n=16). Clinical and biochemical measurements will be recorded at the baseline, 1st month, 4th month and 7th month of the study. Peri-implant crevicular fluid samples will be collected at baseline, 1st month, 4th month and 7th month. IL-1β, RANKL, OPG levels, and RANKL/OPG ratio will be analyzed from collected samples.
Researchers will evaluate the possible benefits of FGG application in addition to non-surgical therapy by comparing the biochemical and clinical changes in areas with and without FGG application in the treatment of peri-implant mucositis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Individual dental implants with a fixed prosthetic restoration that has been functional for at least 1 year
- •No systemic disease and medication use that may affect periodontal or peri-implanter tissues
- •Not receiving periodontal treatment in the last 6 months
- •Volunteering to participate in the study
排除标准
- •Prosthetic restorations with an excessive contour which do not allow peri-implant pocket measurement
- •Being pregnant or breastfeeding,
- •Autoimmune and/or inflammatory diseases of the oral cavity,
- •Active periodontal disease
- •Smokers (≥ 10 cigarettes per day)
- •Improperly positioned implants
研究组 & 干预措施
Peri-implant healthy group with sufficient keratinized mucosa (≥ 2mm)
Peri-implant mucositis group with sufficient keratinized mucosa (≥ 2mm)
Only non-surgical therapy will apply
干预措施: Non-surgical treatment (Procedure)
Peri-implant mucositis group with insufficient keratinized mucosa (< 2mm) receiving FGG
Free gingival graft will apply following non-surgical therapy
干预措施: Non-surgical treatment (Procedure)
Peri-implant mucositis group with insufficient keratinized mucosa (< 2mm) receiving FGG
Free gingival graft will apply following non-surgical therapy
干预措施: Free gingival graft (Procedure)
结局指标
主要结局
Inflammatory parameter levels in peri-implant crevicular fluid
时间窗: 7th month
Peri-implant crevicular fluid samples will be collected from 3 sites (mesiobuccal, buccal, distobuccal) of the implants using methylcellulose strips PerioPaper® (Oralflow Inc., Smithtown, NY, USA) gently placed into the cleansed and dried pocket for 30 sec. Interleukin-1beta, RANKL and OPG levels and RANKL/ OPG ratio will be evaluated.
Inflammatory parameter levels in peri-implant crevicular fluid
时间窗: Baseline (prior to therapy)
Peri-implant crevicular fluid samples will be collected from 3 sites (mesiobuccal, buccal, distobuccal) of the implants using methylcellulose strips PerioPaper® (Oralflow Inc., Smithtown, NY, USA) gently placed into the cleansed and dried pocket for 30 sec. Interleukin-1beta, RANKL and OPG levels and RANKL/ OPG ratio will be evaluated.
Inflammatory parameter levels in peri-implant crevicular fluid
时间窗: 1st month
Peri-implant crevicular fluid samples will be collected from 3 sites (mesiobuccal, buccal, distobuccal) of the implants using methylcellulose strips PerioPaper® (Oralflow Inc., Smithtown, NY, USA) gently placed into the cleansed and dried pocket for 30 sec. Interleukin-1beta, RANKL and OPG levels and RANKL/ OPG ratio will be evaluated.
Inflammatory parameter levels in peri-implant crevicular fluid
时间窗: 4th month
Peri-implant crevicular fluid samples will be collected from 3 sites (mesiobuccal, buccal, distobuccal) of the implants using methylcellulose strips PerioPaper® (Oralflow Inc., Smithtown, NY, USA) gently placed into the cleansed and dried pocket for 30 sec. Interleukin-1beta, RANKL and OPG levels and RANKL/ OPG ratio will be evaluated.
次要结局
- Plaque index (Silness & Löe, 1964)(7th month)
- Probing depth(7th month)
- Bleeding on probing (Ainamo & Bay 1975)(7th month)
- Gingival Index ( Löe & Silness,1963)(7th month)
- Keratinized mucosa width(7th month)
- Plaque index (Silness & Löe, 1964)(Baseline (prior to therapy))
- Plaque index (Silness & Löe, 1964)(1st month)
- Plaque index (Silness & Löe, 1964)(4th month)
- Gingival Index ( Löe & Silness,1963)(Baseline (prior to therapy))
- Gingival Index ( Löe & Silness,1963)(1st month)
- Gingival Index ( Löe & Silness,1963)(4th month)
- Bleeding on probing (Ainamo & Bay 1975)(Baseline (prior to therapy))
- Bleeding on probing (Ainamo & Bay 1975)(1st month)
- Bleeding on probing (Ainamo & Bay 1975)(4th month)
- Keratinized mucosa width(Baseline (prior to therapy))
- Keratinized mucosa width(1st month)
- Keratinized mucosa width(4th month)
- Probing depth(Baseline (prior to therapy))
- Probing depth(1st month)
- Probing depth(4th month)
研究者
Ayse Ege SELMAN
Principle Investigator
Biruni University