Incidence of Peri-implant Mucositis in Patients With Treated Periodontitis: a Prospective Study.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 277
- 试验地点
- 1
- 主要终点
- Incidence of peri-implant mucositis
研究概览
简要总结
the objective of this study is to determine the incidence of peri-implant mucositis in patients with treated periodontitis and enrolled in periodontal maintenance and to evaluate the associated risk indicators. An analytical prospective observational study will be carried out, with an initial follow-up of 12 months.
详细描述
Introduction
Peri-implant mucositis (PM) is an inflammatory disease induced by the accumulation of bacteria (biofilm) around dental implants, which can be modulated by individual characteristics of the patient, as well as by numerous factors related to a greater accumulation of biofilm in peri-implant tissues. Without correct regular maintenance, this entity can progress to peri-implantitis, a disease in which there is loss of bone supporting the implant. However, the strength of the association of the factors with the appearance of PM remains weak and incidence studies are limited due to their design and methodological inconsistencies. Therefore, the objective of this study is to determine the incidence of PM in patients with treated periodontitis and enrolled in periodontal maintenance and to evaluate the associated risk indicators.
Material and method: An analytical prospective observational study will be carried out, with an initial follow-up of 12 months. Patients with treated periodontitis and enrolled in periodontal maintenance will be selected, consecutively. They need to have implants placed in the Periodontics Specialist Clinic and are going to be rehabilitated at the UCM School of Dentistry. Peri-implant and periodontal clinical records, radiographic records, demographic variables, patient-based variables, and submucosal microbiological samples will be taken on the day of crown placement and after 6 and 12 months. The calculation of the sample size estimates the need to recruit 227 patients. The results will be analyzed using regression models.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Over 18 years of age, able to comply with the protocol and comply with the established visits.
- •Patients with treated periodontitis and enrolled in periodontal maintenance (last maintenance therapy received between 4 and 6 months maximum before inclusion in the study) (Chapple et al., 2018, Sanz et al., 2020).
- •Patients with osseointegrated dental implants waiting for their prosthodontic rehabilitation (fixed prosthesis [individual, partial or complete], hybrid or overdenture).
- •Physical or mental conditions that make it possible to perform appropiate oral hygiene
排除标准
- •Patients with untreated periodontitis.
- •Totally edentulous patients.
- •Patients with peri-implant diseases.
- •Pregnant or in lactating-period patients.
- •Patients undergoing treatment with medication that affects the periodontal/peri-implant status or the immune system (phenytoin, calcium antagonists, corticosteroids or anti-inflammatories).
- •Patients who have taken antibiotics in the last month.
结局指标
主要结局
Incidence of peri-implant mucositis
时间窗: 12 months
The risk of developing PM (patient with at least one implant who has bleeding on probing, with or without suppuration and without progressive radiographic bone loss) during a follow-up period of 12 months.
次要结局
- previous medical history(Baseline)
- Affiliation data(Baseline)
- Width of the mucosa:(12 months)
- smoking habit(Baseline)
- Implant characteristics(Baseline)
- Modified plaque index (mPI)(12 months)
- Implant-Abutment Gap(12 months)
- Other general data(Baseline)
- Mucosal height(Baseline)
- Modified sulcus bleeding Index (mBI)(12 months)
- Microbiological samples(12 months)
- Previous dental history(Baseline)
- Characteristics of the teeth that have been replaced by implants(Baseline)
- Surgical procedure(Baseline)
- Bleeding on probing (BOP)(12 months)
- Suppuration on probing (Sup):(12 months)
- Probing depth (PS)(12 months)
- Characteristics of the restorations(Baseline)
- Mucosal thickness (GM)(Baseline)
- Crown length (CL):(12 months)
- full-mouth periodontal clinical parameters(12 months)
- Radiographic bone level(12 months)
- Emergence angle and profile (concave/straight or convex) of restorations(12 months)
- Patient reported outcomes(12 months)