CompletedNot Applicable

A Study Evaluating OsseoSpeed TX Using Different Drilling Protocols With Immediate Loading

Italy168 participantsStarted 2011-04

Plain-language summary

This study is initiated to support the OsseoSpeedTM TX implant with clinical data showing that a soft bone drilling protocol and immediate loading does not have any important negative effect on marginal bone level maintenance.

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

. Provision of informed consent
. Female/male aged 18 years and over
. History of edentulism in the study area of at least 3 months
. At least 4 months healing after last grafting procedure in the study area
. In need for implant treatment replacing one to four missing single tooth in positions 14-17, 24-27, 34-37 and 44-47
. The study implant position must be surrounded by natural tooth roots, unless the implant will constitute the most distal dentition.
. Deemed by the investigator to be suitable for one stage surgery
. Deemed by the investigator to be suitable for immediate loading

Exclusion criteria

. Unlikely to be able to comply with study procedures, as judged by the investigator
. Uncontrolled pathological processes in the oral cavity
. Known or suspected current malignancy

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

Marginal Bone Level Change

Timeframe: Implant insertion and 12 months post implant insertion

Trial details

NCT IDNCT01340170

SponsorDentsply Sirona Implants and Consumables

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2014-12

Results submitted2023-07-03

View on ClinicalTrials.gov More Edentulism trials