Not Yet RecruitingNot Applicable

Effectiveness of Interproximal Cleaning Devices for Biofilm Removal Around Posterior Single Implants With Peri-Implant Mucositis

75 participantsStarted 2026-02

Plain-language summary

This randomized clinical trial aims to evaluate and compare the efficacy of different interproximal oral hygiene devices for biofilm removal around posterior single dental implants in patients diagnosed with peri-implant mucositis. Peri-implant mucositis is a reversible inflammatory condition of the peri-implant soft tissues caused primarily by bacterial biofilm accumulation. Effective plaque control is essential for the prevention of disease progression to peri-implantitis. However, there is limited clinical evidence regarding the comparative effectiveness of different interproximal oral hygiene devices in implant-supported sites. A total of approximately 75 patients with posterior single implants and peri-implant mucositis will be recruited. Participants will be randomly allocated to one of the study groups, each using a specific interproximal oral hygiene device as part of their daily oral hygiene regimen. All participants will receive standardized oral hygiene instructions at baseline. Clinical parameters related to peri-implant inflammation and plaque accumulation will be assessed at baseline and at follow-up visits at 1, 3, and 6 months. The primary outcome is the reduction of peri-implant biofilm accumulation. Secondary outcomes include changes in clinical inflammatory parameters around the implants. The results of this study are expected to provide clinically relevant evidence to support evidence-based recommendations for interproximal oral hygiene in patients with dental implants affected by peri-implant mucositis.

Who can participate

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: Adults aged ≥18 years. Presence of at least one posterior single dental implant in function for ≥12 months. Diagnosis of peri-implant mucositis, defined as bleeding on probing with probing depths ≤5 mm and no radiographic bone loss beyond initial remodeling. Good general health (ASA I-II). Ability and willingness to comply with study procedures and follow-up visits. Provision of written informed consent. Exclusion Criteria: Diagnosis of peri-implantitis (radiographic bone loss beyond initial remodeling). Uncontrolled systemic diseases affecting periodontal or peri-implant health (e.g., uncontrolled diabetes mellitus). Use of systemic antibiotics or anti-inflammatory drugs within the previous 3 months. Current pregnancy or lactation. Current smoker of \>10 cigarettes/day. History of periodontal therapy or professional implant maintenance within the previous 3 months. Use of medications known to affect bone metabolism (e.g., bisphosphonates). Inability to perform adequate oral hygiene or to attend scheduled study visits.

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

Change in peri-implant biofilm accumulation

Timeframe: Baseline (pre-intervention) to 1month post-intervention, 3 months post-intervetion, 6 months post-intervention

Change in peri-implant biofilm accumulation

Timeframe: Baseline (pre-intervention) to 1month post-intervention, 3 months post-intervetion, 6 months post-intervention

Trial details

NCT IDNCT07393828

SponsorUniversitat Internacional de Catalunya

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-05

View on ClinicalTrials.gov More Peri-implant Mucositis trials

Plain-language summary

Who can participate

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.

What they're measuring

Change in peri-implant biofilm accumulation

Timeframe: Baseline (pre-intervention) to 1month post-intervention, 3 months post-intervetion, 6 months post-intervention

Change in peri-implant biofilm accumulation

Timeframe: Baseline (pre-intervention) to 1month post-intervention, 3 months post-intervetion, 6 months post-intervention