CompletedPhase 2

Clinical Investigation of Mandibular Implant Overdenture

United States30 participantsStarted 1998-11

Plain-language summary

The purpose of this study is to compare the effectiveness of three variable dental implant attachment methodologies in conjunction with lower dental-implant retained/supported complete overdenture treatment. These three methods are all presently used by dental practitioners, but vary significantly in terms of added treatment cost and complexity. The study tests the hypothesis that the least complex and costly method provides an equivalent treatment outcome to other more complex and costly methods.

Who can participate

Age range

21 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: * Adult patient; * Male or female; * At least one year of previous conventional complete denture treatment history; * Willing to accept the conditions of the study and informed consent freely given; * Ability to participate for 6 years; * Able to understand and respond to self-reporting measurement scales used in the study; * Minimum 20-mm interarch distance at the estimated vertical dimension of occlusion; * Adequate bone quality; * Adequate bone quantity to accommodate minimally four 3.75-mm diameter by 7-mm long Brånemark implants. Exclusion: * Administrative or physical considerations which would seriously affect the surgical procedure or construe a hindrance for a six-year involvement; * History of drug or alcohol abuse; * Excessive smoking (1+ pack/day); * Uncontrolled systemic disease; * Inability to undergo minor oral surgery because of health or personal reasons; * Irradiated surgical site; * Unrealistic expectations of the prosthodontic treatment outcome; * Psychological or psychiatric conditions that could influence the subject's reaction to treatment; * Acute or chronic TMD problems; * pregnancy; * Class II jaw relationship; * Conventional dental treatment the treatment of choice.

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

Comparison of implant overdenture clinical modalities using clinical measures to compare treatment outcomes

Timeframe: 6 month and 12 month

Trial details

NCT IDNCT00066014

SponsorVirginia Commonwealth University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2007-01

View on ClinicalTrials.gov More Dental Implantation trials