Non-surgical Treatment of Peri-implantitis With and Without Erythritol Air-polishing: A 12-month Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Changes in probing depth (PD)
研究概览
简要总结
Erythritol is a natural sugar alcohol (a four-carbon polyol) produced by the reduction of erythrose. It is considered safe as food additive and has many of the functional properties that are important for subgingival debridement. Current evidence includes no prospective studies comparing the outcomes of a low abrasive erythritol air-polishing as an adjunctive therapy to conventional titanium and ultrasonic debridement of patients in a maintenance program with peri-implantitis. Thus, the main purpose of this randomized, single-masked controlled trial (RCT) is to assess whether low abrasive erythritol air-polishing has an adjunct effect to conventional non-surgical treatment of peri-implantitis.
详细描述
This RCT will enroll subjects among patients in need for non-surgical treatment of peri-implantitis at a private dental clinic in Stavanger, Norway. Forty patients diagnosed with peri-implantitis on at least one implant will be randomly allocated by tossing a coin into test or control group. Patients with cement-retained and screw-retained supraconstructions will be included.
Treatment of peri-implantitis will be performed by one operator (AS) at baseline, 3-, 6-, 9- and 12-month follow-up visits. Local anesthesia will be used when needed. In the test group, implants will be treated with titanium curette, ultrasonic device and a specially designed nozzle mounted on a hand piece (Perio-Flow) connected to an airflow unit.
In the control group, implant with peri-implantitis will be debrided with titanium curette and ultrasonic device only. Test and control debridement will be performed without time limit. The treatment will continue until the operator is judging the implant surface to be free for supra- and subgingival deposits.
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
- Double (Investigator, Outcomes Assessor)
盲法说明
Forty patients diagnosed with peri-implantitis on at least one implant will be randomly allocated by tossing a coin into test or control group. Two different operators will participate in the study (ML and AS). ML masked to the treatment assignment, will collect the data, and AS will perform the treatment.
入排标准
- 年龄范围
- 20 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Healthy subjects aged 20 - 85 years who have received one or more dental implant(s) being in successful function for more than 12 months and restored with an optimal supraconstruction
- •Diagnosed with peri-implantitis based on the following criteria:
- •Bleeding and/or suppuration upon gentle probing
- •Increased probing depths (PD) compared with previous examinations or PD of ≥ 4 mm in at least one site around the implant
- •Crestal bone level (CBL) loss ≥2 mm compared with baseline registration
排除标准
- •Surgical treatment of peri-implantitis the last 6 months
- •Supportive periodontal therapy within 3 months
- •Use of systemic antibiotic within 6 months
- •A history of non-compliant behavior
- •Inflammation around implant without evidence of bone loss
- •Periapical peri-implantitis
- •Subjects with implant fracture, ceramic implants, or detectable subgingival cement
- •Any current medical condition affecting the use of the abrasive air-polishing device.
- •Subjects with diabetes mellitus, cancer, HIV/aids, acute infections, liver or kidney dysfunction/failure,
- •Current pregnancy or breastfeeding
研究组 & 干预措施
Titanium curette and ultrasonic.
Control implants will be debrided with titanium curette and ultrasonic device without time limit.
干预措施: Titanium curette. (Procedure)
Titanium curette and ultrasonic.
Control implants will be debrided with titanium curette and ultrasonic device without time limit.
干预措施: Ultrasonic (Procedure)
Titanium curette, ultrasonic and air-polishing.
Test implants will be treated with titanium curette, ultrasonic device and a specially designed nozzle mounted on a hand piece (Perio-Flow) connected to an airflow unit also without time limit.
干预措施: Titanium curette. (Procedure)
Titanium curette, ultrasonic and air-polishing.
Test implants will be treated with titanium curette, ultrasonic device and a specially designed nozzle mounted on a hand piece (Perio-Flow) connected to an airflow unit also without time limit.
干预措施: Ultrasonic (Procedure)
Titanium curette, ultrasonic and air-polishing.
Test implants will be treated with titanium curette, ultrasonic device and a specially designed nozzle mounted on a hand piece (Perio-Flow) connected to an airflow unit also without time limit.
干预措施: Air-polishing (Procedure)
结局指标
主要结局
Changes in probing depth (PD)
时间窗: 12 moths
PD as the distance in mm from the implant mucosal margin to the probable base of the pocket at six sites;
Crestal bone level (CBL)
时间窗: 12 months
Intraoral digitalized radiographs will be taken with customized Eggen-holder and long cone, parallel technique to assess CBL. The distance from implant platform to the mesial and distal bone levels will be measured by using the software program DIGORA (Soredex, Helsinki).
次要结局
- Bleeding on probing (BoP)(12 months)
- Gingival crevicular fluid (GCF)(12 months)
- Visual analogue scale (VAS)(12 months)
研究者
Knut N. Leknes
Professor
University of Bergen