Progression and Resolution of Experimental Peri-implant Mucositis on Now Healthy Implant Sites That Were Previously Treated With or Without Implantoplasty: A Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Changes in the modified Gingival Index (mGI) between 21 and 42 days
研究概览
简要总结
This controlled clinical trial will assess clinically, immunologically, and microbiologically the healing of experimental peri-implant mucositis (PIM) lesions in implants treated previously with implantoplasty (IP) compared to those treated without IP.
详细描述
The present parallel controlled clinical trial is designed as a 21-day experimental peri-implant mucositis, followed by a period of resolution of 21 days in healthy implants that were previously treated for peri-implantitis with and without implantoplasty.
A total of 8 appointments over the course of about 42 days will be necessary. These appointments will take place in the Department of Periodontics & Preventive Dentistry and are described as follows:
Screening Appointment (14 days prior to Day 0): During this visit, informed consent will be obtained from each subject and inclusion criteria for participation in the study will be reviewed. Participants will undergo the following activities:
- Review of medical, dental history and medications
- Periodontal chart
- Intraoral photographs
- Periapical radiograph of the dental implant that was previously treated with or without implantoplasty to confirm if the implant is in healthy condition with no progressive bone loss
- A digital impression (intraoral scan) of the teeth will be taken for fabrication of a customized stent (a plastic cover). The participant will be instructed to place the stent over the implant whenever performing oral care measures (brushing/flossing/mouthrinse) at home for 21 days. The authors will teach the individuals on how to use this stent and how to brush the teeth/implant(s) during the study. The stent will be provided at the next research visit.
- A professional prophylaxis (dental cleaning) of all tooth and implant surfaces.
V2 - V5 (from day 0 to day 21), the experimentally induced peri-implant mucositis phase, the participant will be wearing the stent over the implant area during their routine oral health care. The following research activities will occur:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 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
- •Aged 18-80 years
- •In good general health, (at least ASA 2)
- •Previously treated implants must have probing depths (PD) ≤ 4 mm
- •Previously treated implants must have <50% bone loss around the implant of interest (assessed radiographically)
- •Patients must have been treated previously for peri-implantitis with or without IP, with at least 1 thread or 2 mm of implant surface exposed in the oral cavity.
- •Have little to no bacteria on the implant(s) of interest (modified Plaque Index of <1) by Day 0
- •Have healthy gums that do not bleed around the implant(s) of choice (modified Gingival index <1) by Day 0
- •Have evidence of stable bone levels around the treated implant for > 6 months
排除标准
- •Active infectious diseases of any kind.
- •Medical conditions which require premedication prior to dental treatments/visits.
- •Pregnant women or planning to become pregnant (self-reported).
- •Patients with congenital or metabolic bone disorders (ie. osteoporosis, vitamin D deficiency, parathyroid disease, etc.)
- •Current heavy smokers: Subjects who have smoked more than 1 pack/day within 6 months of study onset (self-reported)
- •Subjects with co-morbid conditions (i.e., uncontrolled diabetes, cardiovascular disease, impaired kidney function, heart murmur, rheumatic fever, bleeding disorder, hepatitis, tuberculosis, HIV) that would affect the study outcome or interpretation of study results will be excluded.
- •Concomitant medications: Subjects on significant concomitant drug therapy for systemic conditions (i.e., Chronic anti-inflammatory medication, antibiotics, anticoagulants, any medication initiated <3 months prior to the screening visit) will not be included in the study. Occasional short-term use (7-14 days) of analgesics or common cold medication is permitted. Such use of these medications will be reviewed and recorded by the Investigator.
研究组 & 干预措施
Implants with history of peri-implantitis
Implant(s) treated previously for peri-implantitis with or without exposed polished surface, no PD > 4 mm and < 50% bone loss.
干预措施: Induction of experimental peri-implant mucositis (Procedure)
Implants with history of peri-implantitis
Implant(s) treated previously for peri-implantitis with or without exposed polished surface, no PD > 4 mm and < 50% bone loss.
干预措施: Resolution of experimental peri-implant mucositis (Procedure)
结局指标
主要结局
Changes in the modified Gingival Index (mGI) between 21 and 42 days
时间窗: At 21 and 42 days
The mGI will be assessed according to the following criteria: Score 0 - No bleeding on probing; Score 1 - Bleeding dot; Score 2 - Continuous line of blood that fills the sulcus; Score 3 - Profuse bleeding and/or hemorrhage drip. Changes in the scores between day 21 and day 42 will be determined, being 0 minimum and 3 maximum. The mGI will be assessed weekly.
次要结局
- Changes in probing depth (PD)(Up to 42 days)
- Marginal bone loss (MBL)(From baseline to 42 days)
- modified Plaque Index (mPI)(Up to 42 days)
- Peri-implant crevicular fluid (PICF) immunologic profile(Up to 42 days)
- Microbiological profile of the biofilm analysis(Up to 42 days)
研究者
Andrea Ravida
Assistant professor
University of Pittsburgh