Impact of Keratinized Mucosa Augmentation as an Adjunct to Non-Surgical Therapy in the Management of Peri-Implantitis
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Change in PPD
研究概览
简要总结
This study aims to increase the width and thickness of peri-implant keratinized mucosa (KM) by transferring a properly dimensioned free gingival graft (FGG) from the palatal donor site and to evaluate its effect as an adjunctive approach to non-surgical peri-implantitis therapy. The procedure is indicated for patients diagnosed with peri-implantitis who present with an inadequate KM (midbuccal KM height < 2 mm). One month after non-surgical therapy, patients in the test group will undergo keratinized mucosa augmentation using an FGG, while patients in the control group will continue with supportive periodontal therapy and regular follow-up visits. The primary outcome measure of the study is the change in probing depth (PD) at 12 months following peri-implantitis treatment.
详细描述
Background and Case Definition
Peri-implantitis is a disease that typically develops from peri-implant mucositis, an inflammatory condition affecting the soft tissues surrounding dental implants. If left untreated, peri-implant mucositis may progress to peri-implantitis, leading to loss of supporting hard and soft tissues. Clinical signs of peri-implantitis include bleeding on probing (BoP), erythema of the peri-implant mucosa, suppuration, and increased probing depths (PD ≥ 5 mm). The presence of peri-implant bone loss on radiographic examination is a key diagnostic criterion for peri-implantitis.
Although increased width and thickness of keratinized mucosa have been suggested to support peri-implant tissue stability, their role in maintaining peri-implant health and improving the response to peri-implantitis therapy remains controversial. Given the ongoing debate regarding the role of keratinized mucosa dimensions in modulating the response to non-surgical peri-implantitis therapy, further clinical evidence is warranted.
The hypothesis of this study is that adjunctive keratinized mucosa augmentation following non-surgical peri-implantitis therapy results in improved clinical outcomes compared to non-surgical treatment alone. Therefore, the aim of this study was to investigate whether adjunctive keratinized mucosa augmentation improves clinical and radiographic outcomes compared to non-surgical peri-implantitis therapy alone.
Study Population Inclusion Criteria
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
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Non-smoker
- •Systemically healthy
- •Keratinized mucosa witdh < 2 mm
排除标准
- •İntake of medications that impede periodontal tissue health and healing
- •Pregnancy or lactation
研究组 & 干预措施
Control group
Non-surgical treatment of peri-implantitis alone
干预措施: Submucosal debridman + saline irrigation (Other)
Test Group
Non-surgical treatment of perı-implantitis + Free gingival graft procedure
干预措施: Free gingival graft surgery (Procedure)
结局指标
主要结局
Change in PPD
时间窗: Following at 12. months post-treatment
次要结局
- Bleeding on Probing(Following at 12. months post-treatment)
- Keratinized mucosa thickness(Following at 12. months post-treatment)
- Plaque index(Following at 12. months post-treatment)
- Keratinized mucosa width(Following at 12. months post-treatment)
研究者
Sıla Çağrı İşler
Professor Dr
Gazi University