the role of functional epigenetic modifications in peri-implantitis

Conditions: Periimplantitis

Summary: the aim of this pilot, exploratory, single blind clinical trial is to evaluate the epigenetic changes associated with peri-implantitis.

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.

Eligibility criteria:
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.