CompletedNot Applicable

Study Comparing Appearance and Function of Three Different Dental Implant Designs When Placed in Front Region of Upper Jaw

United States, Canada141 participantsStarted 2009-02

Plain-language summary

The primary objective is to compare the gum response to three different dental implant designs when placed in the front region of the upper jaw. The changes from baseline to one year after will be compared. The null-hypothesis is that the buccal soft tissue (gum) changes from baseline to one year after are equal for all three implant-abutment interface settings.

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 * At least 18 years * In need of one or more single implants replacing missing or non-restorable teeth in the maxilla within region 14 to 24 The following should be considered at inclusion but can not be fulfilled until at Visit 2: * Edentulous for at least 5 months at study site * A buccal-lingual bone width at study site of at least 5.5 mm * A mesial-distal bone level distance between adjacent teeth at study site of at least 5.5 mm * A keratinized mid-buccal mucosal height of at least 2 mm at study site * Teeth adjacent (mesial and distal) to study site must consist of two stable teeth on natural roots without signs of periodontal bone loss (\>1 mm) and/or significant soft tissue loss * Teeth adjacent (mesial and distal) to study site must demonstrate a stable occlusal guidance that will allow non-functional disclusion in all eccentric positions * An opposing dentition with teeth, implants or prosthesis Exclusion Criteria: * Insufficient interocclusal distance for implant placement and restoration at study site * Tooth adjacent (mesial and/or distal) to study site is ankylosed * More than 2 mm vertical bone loss at study site as measured from the mid-buccal crest of bone on the adjacent teeth * Site development (bone tissue) performed at less than 5 months before Visit 2 at study site * Untreated rampant caries and/or uncontrolled periodontal disease * Class II division 2 malocclusion (Edward Hartley Angle) * Use of t…

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

Buccal Soft Tissue (Gum) Changes, Measured as Mid-buccal Gingival Zenith (GZ) Scores.

Timeframe: Evaluated at time of loading (permanent restoration) and at the 5-years follow-up after loading

Trial details

NCT IDNCT00820235

SponsorDentsply Sirona Implants and Consumables

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2016-09

Results submitted2020-04-24

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