Periimplantitis Clinical Trial
Official title:
The Role of Functional Epigenetic Modifications in Peri-Implantitis: A Pilot Clinical Study
Verified date | March 2021 |
Source | NYU College of Dentistry |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
The aim of this pilot, exploratory, single blind clinical trial is to evaluate the epigenetic changes associated with peri-implantitis.
Status | Active, not recruiting |
Enrollment | 20 |
Est. completion date | July 2021 |
Est. primary completion date | July 2021 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 20 Years to 90 Years |
Eligibility | Inclusion Criteria: 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). Exclusion Criteria: 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. |
Country | Name | City | State |
---|---|---|---|
United States | Bluestone Center for Clinical Research. New York University College of Dentistry | New York | New York |
Lead Sponsor | Collaborator |
---|---|
NYU College of Dentistry |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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) | Gingival and blood samples collected from healthy subjects and subjects with peri-implantitis will be used to determinate epigenetic signatures associated with peri-implantitis. | 6 months | |
Primary | 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. | 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) | 6 months | |
Secondary | Visual Analog Scale (VAS) will be assessed to determinate patient-reported outcome measures, at baseline and at 6 months. | A visual analog scale (VAS) will be used to evaluate patient's pain/discomfort, esthetic satisfaction, and the subjects' overall satisfaction at baseline and at 6 months. | 6 months | |
Secondary | Oral Health Impact Profile-14 (OHIP-14) will be assessed to determinate patient-reported outcome measures, at baseline and at 6 months. | Oral Health Impact Profile-14 (OHIP-14) assessed at baseline and at 6 months. | 6 months | |
Secondary | Changes in peri-implant pocket depths (PPD) (in mm) from baseline to 6 month after surgery (only peri-implantitis group). | Peri-implant pocket depths (PPD) will be assessed at baseline and 6 month after surgery. | 6 months | |
Secondary | Changes in peri-implant BOP (in percentage), from baseline to 6 month after surgery (only peri-implantitis group). | Peri-implant BOP (in percentage) will be assessed at baseline and 6 month after surgery. | 6 months | |
Secondary | Percentage of peri-implant pocket closure at to 6 month after surgery (only peri-implantitis group). | Percentage of peri-implant pocket closure will be assessed at at to 6 month after surgery. | 6 months | |
Secondary | Changes in peri-implant marginal bone level (in mm) from baseline to 6 month after surgery (only peri-implantitis group). | Mean crestal bone level change around the implants will be determined by periapical radiographs of mesial and distal bone levels from baseline to 6 months surgery. | 6 months | |
Secondary | Change in soft tissue levels (in mm) from baseline to 6 month after surgery (only peri-implantitis group). | Soft tissue levels assessed at baseline and 6 months post-surgery in implants with peri-implantitis. | 6 months | |
Secondary | Incidence of post-operative surgical site infections (only peri-implantitis group). | Number of post-operative surgical site infections from surgery to 6 months. | 6 months | |
Secondary | Incidence of post-operative complications (only peri-implantitis group). | Number of post-operative complications from surgery to 6 months. | 6 months |
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