A Comparison of Two Different Mechanical Interventions in Non-Surgical Peri-implantitis Treatment
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Periodontal depth decrease
研究概览
简要总结
As the frequency of dental implants increases, the incidence of complications and peri-implant diseases also increases. Early diagnosis and treatment of the disease is important to prevent consequences up to implant loss. Non-surgical treatment is the recommended treatment in the first stage due to its shorter duration and low morbidity rate. Non-surgical treatment of peri-implantitis provides clinical improvements such as reduced bleeding on probing (20-50%) and, in some cases, reduced pocket depth (≤ 1 mm). This study aims to clinically and radiographically compare two different mechanical treatments in patients with mild and moderate peri-implantitis.
详细描述
60 patients with at least one implant with mild to moderate peri-implantitis, defined as 2-4 mm radiographic reduced bone level, bleeding index (BI) ≥ 2, and probing pocket depth (PPD) ≥ 4 mm will be randomly allocated to test and control groups, receiving titanium curettes or ultrasonic Carbon tips debridement, respectively. Treatment was performed at baseline. Plaque index (PI), gingival index (GI), Periodontal pocket depth (PD), Bleeding on probing (BOP) gingival recession (GR) and Clinical attachment level (CAL) will be measured at four sites per implant and recorded by examiner at baseline, one, three, six and twelve months. Pus will be recorded as present/not present. The radiographic marginal bone level changes will be calculated at baseline, third months, sixth months and 12 months.
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
- Single (Outcomes Assessor)
盲法说明
For Outcomes Assessor Masking, Groups were not defined and anonymized and assessor will be blind.
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adult patients (≥18 years old)
- •Systemically healthy (ASA class 1 and ASA class 2)
- •Full-mouth plaque scores ≤20%
- •Implant had been in function for more than 6 months
- •Absence of plaque around the implant
- •Consent to complete all follow-up visits
排除标准
- •Mobile implant
- •Overhanging restorations that prevent access to the implant for clinical measurements
- •Unresolvable technical complications that can cause peri-implantitis
- •Presence of active periodontal disease
- •Implants with a history of peri-implantitis treated using graft materials
- •Use of drugs that cause gingival hyperplasia
- •Systemic antibiotic use in the last 3 months
- •Acute and chronic medical conditions that prevent the patient from participating in the study
- •Presence of uncontrolled severe peri-implantitis from neighbouring implants
- •History of radiotherapy in the head and neck region
- •Receiving acute chemotherapy
- •Current corticosteroid therapy
结局指标
主要结局
Periodontal depth decrease
时间窗: Baseline to 12th month
Periodontal pocket depth (PD) decreasing baseline to 12th month
次要结局
- marginal bone level changes(Baseline to 12th month)
研究者
Berceste Guler
Assoc Prof
Kutahya Health Sciences University