CompletedNot Applicable

Treatment of Peri-implantitis With or Without Simultaneous Soft Tissue Augmentation

Italy32 participantsStarted 2021-02-05

Plain-language summary

The study will aim to compare two modalities in the reconstructive treatment of peri-implantitis defects. More specifically, the control group will be a reconstructive approach (xenograft bone graft granules and collagen membrane, BioOss and BioGide, Geistlich, Wolhusen). The test group will be the same, with the exception of an autologous sub-epithelial connective tissue palatal graft, sutured beneath the flap, which will be used in addition to grafting materials. Outcomes will include CAL, PD, MR, defect resolution, PI, BoP, SUPP, surgical characteristics, and patient-reported outcome measures, including an aesthetic self-evaluation.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * · Be able and willing to provide consent and sign the informed consent form. * Be able and willing to comply with study procedures and follow-up appointments required by the study protocol. * Age\>18 years * Presence of at least one implant affected with peri-implantitis, defined as the following con-dition: at least one site presenting peri-implant probing depth (PPD) \>6 mm and simultane-ous presence of profuse BoP/SUP and a radiographically documented change in bone level greater than initial bone remodeling. In the likely event that a baseline radiographic image is absent, the bone level will be compared to where it would likely have been at the time of implant insertion and a difference of \>3 mm from that level will be considered. * Implants in function (i.e. loaded) for at least 1 year. * Screw- and cement-retained suprastructures for both fixed and removable prostheses. Exclusion Criteria: * Compromised systemic health which contraindicates the study procedures. * Pregnant or nursing women. * Cigarette smoking\>5 per day * Systemic conditions compromising healing (i.e. diabetes mellitus). Patients with diabe-tes mellitus types I or II will be asked to provide information regarding their most re-cent HbA1c values. Only patients with HbA1c\<7% will be enrolled. * Patients taking medications known to interfere with gingival or bone metabolism.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Clinical attachment level

Timeframe: change from baseline to: 6, 12, 18, 24 months

Trial details

NCT IDNCT04323540

SponsorGeorge Eastman Dental Hospital, Italy

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-01-01

View on ClinicalTrials.gov More Peri-Implantitis trials