CompletedNot Applicable

Study of Bone Preservation When OsseoSpeed™ Implants Are Placed Immediately Following Tooth Extraction

Italy, Spain, Switzerland104 participantsStarted 2005-12

Plain-language summary

The purpose of this study is to evaluate the clinical performance of implants placed in individuals who are about to loose one or more of their upper teeth. The main objective is to study how the surrounding bone tissue reacts to two different shapes of implants. Clinical performance, in wider terms, means esthetics and long lasting function. Half of the patients will receive a cylindrically shaped implant and the other half will receive a conical-cylindrical implant. The implants will be placed and after a healing period of 16 weeks the gum will be re-opened and the bone tissue response clinically evaluated. Permanent artificial tooth/teeth will be attached six weeks after that.

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 written informed consent * At least 18 years at inclusion * At least 20 teeth with expected functional balanced occlusion after restoration * In need of one or more implants replacing teeth to be removed in the maxilla within region 15 to 25 * Presence of an intact extraction socket following removal of the natural tooth defined by: (1) a situation where the marginal border of the facial bone crest deviates less than or equal to 2 mm from that of the expected normal anatomy of the site/region, (2) a marginal border of a potential facial fenestration at least 3 mm apical of the marginal bone crest * Presence of an extraction socket anatomy, following removal of the natural tooth, suitable for both cylindrical and conical/cylindrical implants Exclusion Criteria: * Untreated rampant caries and uncontrolled periodontal disease * Absence of adjacent (mesial and/or distal) natural tooth root * Uncontrolled diabetes (subjects history does not reveal the absence of control of insulin-dependent / non-insulin dependent Diabetes Mellitus) * Current alcohol or drug abuse * Systemic or local disease or condition that would compromise post-operative healing and/or osseointegration * Need for systemic corticosteroids or any other medication that would compromise post-operative healing and/or osseointegration * History of radiation in the head and neck region * History of chemotherapy within 5 years prior to surgery * Unable or unwilling to return for fo…

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

Clinical measure of the thickness of the facial bone wall.

Timeframe: At implant placement and after 16 weeks of healing.

Trial details

NCT IDNCT00711282

SponsorDentsply Sirona Implants and Consumables

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2011-06

View on ClinicalTrials.gov More Jaw, Edentulous, Partially trials