Influence of Keratinized Mucosa on Dental Implants With Mucositis in Patients Undergoing Supportive Periodontal Therapy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 38
- 试验地点
- 2
- 主要终点
- Bleeding on probing
研究概览
简要总结
Introduction:
It seems that some local and systemic factors can be associated with an increased incidence of peri-implant diseases. Predisposing to an increase inflammatory response when plaque is present.
There is still controversy on which factors can be considered as risk indicators. One of them is the keratinized mucosa width (KM), that seems to facilitate plaque control around implants.
Objectives:
Assess the relationship between keratinized mucosa and the recurrence of mucositis, comparing bleeding on probing (BOP) in implants with mucositis for 24 weeks after implant disinfection therapy, the control group is defined by having KM ≥ 2 mm and the test group KM < 2 mm.
Material and methods:
38 patients presenting one single implant each with a single screw retained crown loaded for at least 1 year. Periodontal maintenance therapy will be performed and oral hygiene instruction will be delivered. Follow up visits will be after 8, 12 and 24 weeks in which the following parameters will be registered: Keratinized Mucosa width, Attached mucosa, Gingival Index, Vestibule Depth, Mucosa Thickness. Probing Pocket Depth, Recession, modified Plaque Index, Bleeding on Probing, modified Bleeding Index. Also a microbiologic test will be taken in the implant sulcus before the periodontal maintenance therapy and at 24 weeks.
A multilevel statistical analysis will be conducted comparing the control and the test group, adjusting for the correlation among multiple observations.
详细描述
Introduction:
It seems that some local and systemic factors can be associated with an increased incidence of peri-implant diseases. Predisposing to an increase inflammatory response when plaque is present.
There is still controversy on which factors can be considered as risk indicators. One of them is the keratinized mucosa width (KM), that seems to facilitate plaque control around implants.
Objectives:
Assess the relationship between keratinized mucosa and the recurrence of mucositis, comparing bleeding on probing (BOP) in implants with mucositis for 24 weeks after implant disinfection therapy, the control group is defined by having KM ≥ 2 mm and the test group KM < 2 mm.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 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
- 否
入选标准
- •patients> 18 years;
- •smokers <10 cigarettes / day;
- •partially edentulous patients. The spaces must be associated with at least one adjacent mesial and one distal tooth;
- •presence of bleeding and / or suppuration on probing, erythema and inflammation;
- •absence of radiographic bone loss around implant distance (<2mm from expected radiographic marginal bone level);
- •individual dental implants rehabilitated for more than a year;
- •screw-retained restorations on implants;
- •absence of active periodontal disease;
- •who have not taken systemic antibiotics in the last 3 months;
- •adequate oral hygiene motivation and collaboration defined as plaque index <25%
排除标准
- •totally edentulous patients;
- •uncontrolled systemic diseases;
- •diseases of the mucosa (erosive lichen planus, etc.);
- •taking medications that may interfere with periodontal health or healing; (corticosteroids, calcium channel antagonists, antiepileptic drugs, immunosuppressants, etc.)
- •pregnant or lactating patients;
- •cemented implant restorations;
- •restorations on implants over contoured that cannot be corrected.
结局指标
主要结局
Bleeding on probing
时间窗: 24 weeks
The main objective of the study is to evaluate the association between MQ and recurrence of mucositis, comparing the bleeding index on probing (BoP) in implants that have mucositis, in a control group characterized by 2 mm or more of MQ and a test group characterized by less than 2 mm of MQ over a 24-week period after peri-implant maintenance therapy.
次要结局
未报告次要终点
研究者
Gonzalo Blasi
Clinical Instructor
Universitat Internacional de Catalunya