Efficacy of a Xanthan-based Chlorhexidine Gel in the Treatment of Peri-implant Mucositis: a Randomized Split-mouth Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 182
- 试验地点
- 2
- 主要终点
- Bleeding on Probing
研究概览
简要总结
The peri-implant mucositis is an inflammatory and reversible lesion that surrounds the peri-implant mucosa without loss of supporting bone, clinically characterized by bleeding on gentle probing. It has been estimated that it affects approximately 21% to 88% of individuals and 9% to 51% of implant sites, with prevalences of 47% and 29%, respectively.
Experimental clinical researches show that peri-implant mucositis can be reversed if proper biofilm management is maintained. Prevention and regression of inflammation around the implant can be achieved through proper oral hygiene and an effective supportive care protocol, which may include regular clinical check-ups, radiographic assessments, oral hygiene instructions and professional mechanical plaque removal (PMPR).
Therefore, adjunctive measures such as self-administration of oral rinse antiseptics (i.e. chlorhexidine) may be considered. For examples, the use of a chlorhexidine-based gel in combination with xanthan (XanCHX), in addition to PMPR has demonstrated clinical improvements in the treatment of periodontitis.
The aim of the present study was to investigate the potential benefits of XanCHX gel in adjunction to PMPR in patients affected by peri-implant mucositis, promoting a complete healing of the affected tissues.
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 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •presence of two or more peri-implant mucositis sites (e.g. presence of bleeding and/or suppuration on probing with no bone loss evident on radiographs);
- •implant-supported fixed restorations inserted at least 6 months before patient enrollment
排除标准
- •radiation therapy in the head and neck therapy or long-term corticosteroid treatments;
- •use of systemic antibiotics for more than 6 months;
- •diagnosis of not plaque-associated inflammatory diseases (e.g., Oral Lichen Planus);
- •pregnant or breastfeeding mother;
- •untreated peri-implantitis;
- •oral rehabilitation with full-arch prostheses;
- •allergy to chlorhexidine and/or other components contained in the gel.
结局指标
主要结局
Bleeding on Probing
时间窗: From baseline until the end of the study (6 months)
Presence or absence of gingival bleeding within 30 seconds after probing
次要结局
- Probing pocket depth(From the baseline until the end of the study (6 months))
- Gingival recession(From the baseline until the end of the study (6 months))
- Clinical attachment level(From the baseline until the end of the study (6 months))
- Plaque index(From baseline until the end of the study (6 months))
- Keratinized gingiva(From the baseline until the end of the study (6 months))
研究者
Jacopo Lanzetti
Dental Hygienist Registered (RDH)
University of Turin, Italy