Erythritol Air Polishing in Mucositis Treatment: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Changes in Bleeding on Probing compared to baseline
研究概览
简要总结
This study aimed to evaluate the effectiveness of air polishing systems compared to the exclusive use of oral hygiene instruction in the treatment of peri-implant mucositis
详细描述
The study will include individuals aged 18 to 80 who have at least one implant and exhibit peri-implant mucositis, as defined by the 2017 World Workshop on the Classification of Periodontal and Peri-Implant Diseases and Conditions.
Participants will be selected from those attending Periodontology, Oral Surgery, and Oral Medicine consultations at the dental medicine clinic of the University Hospital Center of the University of Coimbra (CHUC). After confirming the inclusion and exclusion criteria, patients will be invited to participate in the study, and if they agree to participate, they will sign an Informed Consent Form.
The study is conducted as a parallel-design clinical trial, and each participant will be randomly allocated to one of three groups: Test 1 (T1), Test 2 (T2), or Control (C).
Group T1 will consist of patients receiving a single application of treatment with an air-polishing device with erythritol, in addition to oral hygiene instructions (OHI). Group T2 will consist of patients receiving monthly applications (months 0, 1, and 2) of treatment with an air-polishing device with erythritol, along with OHI. Group C will consist of patients receiving only OHI. The treatments and OHI will be performed by an experienced periodontist who is different from the one collecting clinical, radiographic, and PICF data.
The clinical examination that will be performed at baseline, 3 and 6 months after baseline includes a periodontal chart at six sites per each tooth and/or included implant.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adults with at least one implant in function for a minimum of one year affected by peri-implant mucositis.
排除标准
- •Pregnant or lactating women
- •patients unable to understand the treatment protocol and sign informed consent and/or patients younger than 18 years old,
- •medical conditions that prevents an oral examination,
- •incapability to perform oral hygiene measures due to physical or mental disorders,
- •patients with uncontrolled systemic diseases or neoplasms, infection with HIV or hepatitis, cardiovascular disease, blood disorders (e.g. coagulation disorders) and severe osteoporosis,
- •patients who have received systemic antibiotics, corticosteroids, or immunosuppressive therapy within 3 months before periodontal evaluation (baseline), as well as those who chronically use nonsteroidal anti-inflammatory drugs, require antibiotic coverage for dental procedures, and those who are undergoing chronic treatment with medications known to affect periodontal health (such as phenytoin or cyclosporine),
- •alcohol or drug addiction
- •implants with mobility and/or occlusal overload.
结局指标
主要结局
Changes in Bleeding on Probing compared to baseline
时间窗: Baseline, 3 months and 6 months
Bleeding on Probing (BoP) will be evaluated according to the modified bleeding index (0-no BoP; 1- punctiform drop of bleed; 2- confluent red continuous line formed through the sulcus; 3-heavy/profuse), for each site
次要结局
- Probing Pocket Depth(Baseline, 3 months and 6 months)
- Plaque index (PI)(Baseline, 3 months and 6 months)
- Gingival Recession(Baseline, 3 months and 6 months)
- Radiographic bone level(Baseline, 3 months and 6 months)
- Keratinized Tissue(Baseline, 3 months and 6 months)
- Biochemical outcomes(Baseline, 3 months and 6 months)
- Complete Disease Resolution(3 months and 6 months)
- Prosthetic Margin Level(Baseline, 3 months and 6 months)
研究者
Orlando Martins
Visiting Assistant Professor
University of Coimbra