CompletedNot Applicable

Rehabilitation of Single Aesthetic Areas Using Narrow Diameter Implants

Italy17 participantsStarted 2024-09-01

Plain-language summary

The scientific literature does not provide scientific evidence on how to manage patients suffering from monoedentulism with ridges having a reduced bone thickness or a reduced mesio-distal space. Narrow diameter implants could be a solution to rehabilitate patients suffering from these clinical conditions while avoiding longer, more complex and sometimes even multidisciplinary therapies. However, there is a lack of clinical studies analyzing the outcomes of rehabilitation with narrow diameter implants.

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: * Patients who have undergone implant surgery to perform implant rehabilitation of single edentulism in the anterior region to insert a reduced diameter implant; * ASA I and ASA II patients; * Age \> 18yr; * Non-smokers or smokers ≤ 5 cig/day; * Achievement of FMPS and FMBS ≤ 15%; * Signing of the written informed consent to participate in the study. Exclusion Criteria: * Severe general medical pathologies; * Immunodeficiency states; * Radiotherapy in the head and neck region; * Uncontrolled diabetes or hypertension; * Smokers \>5 cigs/day; * Impossibility to carry out homogeneous and continuous follow-up; * Documented allergy to the biomaterials used; * Pregnancy or breastfeeding; * Inability to provide written informed consent.

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

peri-implant marginal bone loss in millimeters

Timeframe: 12 months from implant placement

Trial details

NCT IDNCT06528587

SponsorFondazione Policlinico Universitario Agostino Gemelli IRCCS

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2025-11-01

View on ClinicalTrials.gov More Implant Complication trials