TerminatedNot Applicable

Treatment With Fixture Microthread™ in Patients With Poor Bone Quality and no Teeth in the Upper Jaw, When Using Two-Stage Surgery

Stopped: Decision to modify the product under study as a result of feedback regarding subjective feeling during installation procedure. For more info, see brief summary.

United States, Sweden23 participantsStarted 1999-09

Plain-language summary

The primary objective of the study is to evaluate the long-term survival rate of individual implants and prostheses when treating edentulous upper jaws of poor bone quality with Fixture MicroThread™ (Micro-Macro). Clinical study recruitment was stopped in year 2000 due to a decision to modify the product under study. This was a result of feedback regarding the subjective feeling during the installation procedure. There were no safety concerns w/r to the study products. Patients already included and treated in the study were monitored for the full duration of the study in accordance with the clinical study protocol.

Who can participate

Age range

18 Years – 75 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: * 18 - 75 years of age * Bone quality class III or IV, (according to Lekholm \& Zarb16) * Willing to give signed informed consent Exclusion Criteria: * Need for bone augmentation of the maxilla * Tobacco smoking more than 5 cigarettes/day * Any systemic disease or condition that would compromise post-operative healing and/or osseointegration * Systemic corticosteroids or any other medication that would compromise post-operative healing and/or osseointegration * Unable or unwilling to return for follow-up visits * Bruxism or other parafunctional activity

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

Implant survival

Timeframe: Continuously during 5,5 years after implant placement

Trial details

NCT IDNCT00748670

SponsorDentsply Sirona Implants and Consumables

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2006-10

View on ClinicalTrials.gov More Jaw, Edentulous trials