The Role of Functional Epigenetic Modifications in Peri-Implantitis: A Pilot Clinical Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Differences in epigenetic signatures in peri-implantitis subjects as compared to healthy subjects, in an exploratory manner. (Gingival biopsies and blood collected to perform DNA methylation analysis)
研究概览
简要总结
The aim of this pilot, exploratory, single blind clinical trial is to evaluate the epigenetic changes associated with peri-implantitis.
详细描述
Twenty patients will be voluntarily enrolled in two groups: 10 healthy participants, and 10 participants with peri-implantitis. Periodontal and peri-implant clinical and radiographic measurements, as well as body mass index, medical and dental history will be recorded within the following timelines: at baseline (for both groups), and 6 months after baseline for the peri-implantitis group only. At baseline, gingival biopsies and blood will be harvested from: a) healthy gingival sites during either surgical removal of wisdom teeth or gingivoplasty, in the healthy group; and, b) from a peri-implantitis site during surgical treatment of peri-implantitis, and when possible, from a healthy gingival site within the same participant, in the peri-implantitis group. After harvesting of biopsies, peri-implantitis subjects will be re-evaluated 6 months after treatment. During the 6-month visit, if a second surgical treatment of peri-implantitis in the same implant treated at baseline is indicated as standard of care of the participant, a new gingiva biopsy and blood will be collected. Gingival biopsies and blood collected from each participant will be used to perform DNA methylation analysis.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 20 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •General Inclusion Criteria:
- •Subjects must have read, understood, and signed an informed consent form.
- •Subjects must be 20-90 years of age.
- •Subjects must be non-smokers or ex-smokers who have quit smoking for at least one year prior to enrollment in the study.
- •Subjects must be in good general health as assessed by the Investigator.
- •Healthy Periodontal Subjects Inclusion Criteria:
- •In addition to the general inclusion criteria, a healthy periodontal subject must meet all of the following criteria:
- •Subjects show gingival health and no history of periodontitis, as described in the 2017 World Workshop on the Classification of Periodontal and Peri-Implant Diseases and Conditions.
- •Peri-implantitis Subjects Inclusion Criteria:
- •In addition to the general inclusion criteria, a PIT subject must meet all of the following criteria:
- •Subjects with implant-supported prosthesis/es in function for at least 12 months who had at least one implant diagnosed with peri-implantitis based on the 2017 World Workshop on the Classification of Periodontal and Peri-Implant Diseases and Conditions.
- •Subjects must be committed to the study and the required follow-up visits.
- •Standard of care treatment of the diseased implant with PID will consist on open flap debridement (OFD).
排除标准
- •General Exclusion Criteria:
- •Pregnant or lactating.
- •Use of antibiotics, within 1 month before enrollment in the study.
- •Chronic use of nonsteroidal anti-inflammatory drugs for over 3 weeks of continuous use at the time of enrollment or during the course of the study.
- •Requirement for prophylactic antibiotics for dental procedures.
- •Mucosal diseases in the localized area around the biopsy site.
- •Subjects with a systemic disease that would preclude biopsy/oral surgery.
- •History of local irradiation therapy in the head/neck area.
- •Subjects with poor oral hygiene.
- •Subjects receiving, or having a history of receiving intravenous or subcutaneous anti-resorptive agents associated with osteonecrosis of the jaw.
- •Subjects with any untreated endodontic lesions or untreated periodontal disease adjacent to the biopsy site.
- •Acute necrotizing ulcerative gingivitis or gross tooth decay, as determined by the investigator.
- •Subjects with conditions or circumstances, in the opinion of the investigator, which would prevent completion of study participation or interfere with analysis.
- •Periodontally Healthy Subjects Exclusion:
- •In addition to the general exclusion criteria, subjects allocated to the healthy group who meet any of the following criteria will be excluded from participation in this study:
- •Root fragments, pericoronitis, endo-perio lesions, gross tooth decay, or other dental abscesses at the biopsy site. Subjects may be rescreened after resolution of these dental conditions.
- •Peri-implantitis subjects Exclusion:
- •In addition to the general exclusion criteria, subjects allocated to the PIT group who meet any of the following criteria will be excluded from participation in this study:
- •Inadequate implant position (i.e., prosthetically driven).
- •PIT due to excess of cement.
- •Subjects who have physical or mental handicaps that would interfere with the ability to perform adequate oral hygiene.
- •Subjects with implants previously surgically treated for PIT.
- •Less than 2mm of keratinized peri-implant tissue.
结局指标
主要结局
Differences in epigenetic signatures in peri-implantitis subjects as compared to healthy subjects, in an exploratory manner. (Gingival biopsies and blood collected to perform DNA methylation analysis)
时间窗: 6 months
Gingival and blood samples collected from healthy subjects and subjects with peri-implantitis will be used to determinate epigenetic signatures associated with peri-implantitis.
Epigenetic signatures associated with response to treatment peri-implantitis at 6 months, in an exploratory manner. (Differences in epigenetic signatures in peri-implantitis subjects as compared to healthy subjects, in an exploratory manner.
时间窗: 6 months
Samples collected from patients with peri-implantitis will be used to determinate epigenetic signatures associated response to treatment peri-implantitis at 6 months. (Gingival biopsies and blood collected to perform DNA methylation analysis)
次要结局
- Changes in peri-implant pocket depths (PPD) (in mm) from baseline to 6 month after surgery (only peri-implantitis group).(6 months)
- Changes in peri-implant BOP (in percentage), from baseline to 6 month after surgery (only peri-implantitis group).(6 months)
- Visual Analog Scale (VAS) will be assessed to determinate patient-reported outcome measures, at baseline and at 6 months.(6 months)
- Incidence of post-operative complications (only peri-implantitis group).(6 months)
- Oral Health Impact Profile-14 (OHIP-14) will be assessed to determinate patient-reported outcome measures, at baseline and at 6 months.(6 months)
- Changes in peri-implant marginal bone level (in mm) from baseline to 6 month after surgery (only peri-implantitis group).(6 months)
- Incidence of post-operative surgical site infections (only peri-implantitis group).(6 months)
- Percentage of peri-implant pocket closure at to 6 month after surgery (only peri-implantitis group).(6 months)
- Change in soft tissue levels (in mm) from baseline to 6 month after surgery (only peri-implantitis group).(6 months)
研究者
Ismael Khouly
Clinical Assistant Professor, Department of Oral & Maxillofacial Surgery
NYU College of Dentistry