Changsha Stomatological Hospital
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 96
- 试验地点
- 1
- 主要终点
- Change in Plaque Index (PLI) Score
研究概览
简要总结
Abstract Objective The purpose of this study was to analyze the factors affecting the occurrence of peri-implant inflammation in patients with oral implant repair, and to explore the effect of subgingival sandblasting technology on the maintenance of microecology around the implant, so as to provide a basis for optimizing clinical prevention and treatment strategies.
Method Ninety-six patients with early periimplantitis treated in our hospital from July 2022 to July 2024 were selected as the inflammation group. All patients were randomly divided into control group, glycine subgingival sandblasting group and erythritol subgingival sandblasting group (n=32). The clinical therapeutic effect of the two groups was compared. A total of 102 patients who underwent oral implant repair in our hospital during the same period without peri-implant inflammation were selected as the group without inflammation. The independent risk factors of peri-implant inflammation were analyzed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of peri-implantitis (PD ≥4 mm with BOP/suppuration)
- •At least one functional dental implant in place for ≥6 months
- •Willing and able to maintain standard oral hygiene protocol
- •No antibiotic or anti-inflammatory drug use in the past 30 days
- •Absence of uncontrolled systemic diseases (e.g., diabetes, hypertension)
- •Complete baseline clinical data available (medical history, radiographs, lab results)
排除标准
- •Acute oral infections requiring immediate treatment
- •History of radiation therapy to the head/neck region
- •Severe uncontrolled periodontal disease
- •Active malignancy or current cancer treatment
- •Coagulation disorders or anticoagulant therapy
- •Pregnancy or lactation
- •Cognitive impairment affecting compliance
- •Allergy to glycine or erythritol compounds
- •Non-Inflammatory Group Additional Criteria Successful implant placement with no signs of inflammation (PD ≤3 mm, no BOP)
- •Matched to study group by age (±5 years) and implant location
- •Meets all other inclusion/exclusion criteria regarding systemic health
- •Note: All participants must provide informed consent. Healthy volunteers without implants are not eligible.
研究组 & 干预措施
control group
The control group was given ultrasonic subgingival curettage. With Swiss EMS ultrasonic therapy instrument, both the operator and the patient should wear safety goggles before operation. After the operator guides the patient to gargle, the mouth opener should be placed to perform ultrasonic subgingival curetting. The debridement time of the implant area should be controlled within 6 minutes, and the debridement time of other sites should be 5 s.
干预措施: control group (Other)
glycine subgingival sandblasting group and erythritol subgingival sandblasting group
Given glycine subgingival sandblasting group glycine subgingival sandblasting group. Swiss EMS ultrasonic therapy instrument and EMS glycine sandblasting were used. Before the operation, both parties should wear safety glasses and place the mouth opener after the patient gargled. The location of sandblasting was selected to be 1-2 mm below the gingiva. During the operation, the time of sandblasting in the planting area should be controlled within 10 minutes, and then the time of sandblasting at other sites with the same amount of water and power should be controlled within 5s. After sandblasting, the patient's mouth was continuously rinsed with normal saline for 20s. After the operation, the patient was informed of the precautions after the operation, and the patient was instructed to master the correct oral maintenance method, pay attention to maintaining the cleanliness around the implant, and adhere to regular periodontal maintenance.
干预措施: glycine subgingival sandblasting group and erythritol subgingival sandblasting group (Other)
结局指标
主要结局
Change in Plaque Index (PLI) Score
时间窗: Baseline, 3 months, 6 months.
Change in Plaque Index (PLI; scored 0-3) from baseline to 3 and 6 months post-treatment, comparing subgingival sandblasting (glycine/erythritol) versus standard ultrasonic curettage. Higher scores indicate greater plaque accumulation.
Change in Bleeding Index (BI) Score
时间窗: Baseline, 3 months, 6 months.
Change in Bleeding Index (BI; scored 0-3) from baseline to 3 and 6 months post-treatment, comparing interventions. Higher scores indicate more severe gingival bleeding.
Change in Probing Depth (PD)
时间窗: Baseline, 3 months, 6 months.
Change in Probing Depth (PD; measured in millimeters) from baseline to 3 and 6 months post-treatment, comparing interventions. Deeper pockets indicate worse peri-implant inflammation.
次要结局
- Inflammatory Biomarker Levels (IL-6, IL-1β)(Baseline, 1 month post-treatment, 3 months post-treatment, 6 months post-treatment)
研究者
Hui Xie
Principal Investigator
Changsha Stomatological Hospital