Dental Implant Clinical Trial
The purpose of this study is to compare two different timings of restoring dental implants that are placed right after tooth extraction: The test group will have the provisional crown placed at the time of implant placement. The control group will have the tooth removed and the implant placed at the same appointment but restorations placed after 4 months. Both procedures currently are accepted methods for replacing missing teeth but direct comparisons of the two procedures are lacking. The results of this study should aid clinicians in selecting the best timing for restoring implants for their patients. The hypothesis is that immediate restoration might increase aesthetic outcomes, e.g. less mucosal recession.
A single center, randomized controlled, parallel-arm study is planned to investigate esthetic
outcomes after immediate placement and restoration in the esthetic zone. Forty adult patients
who have a hopeless maxillary anterior or premolar tooth, with intact adjacent teeth will be
enrolled. A signed written informed consent will be obtained after he or she has been given
verbal and written information describing the nature and duration of the study. Subjects will
not be screened or treated until an informed consent has been obtained. Patient information
will be protected according to the privacy regulations of the Federal Health Insurance
Portability and Accountability Act of 1996 (HIPAA).
The enrolled patients will be randomly placed into one of two treatment groups, immediate
implant placement (IIP) and restoration group (IR) or the IIP + delayed restoration group
(DR). For all patients, the hopeless tooth will be extracted atraumatically and an implant
placed immediately. The decision will be made randomly to either restoring the implant
immediately (Test group) with a provisional crown or restoring the implant at 4 months after
implant placement (Control group). Outcome analyses will be performed until approximately
1-year after the implant surgery and primarily evaluate clinical and radiographic parameters
to determine the esthetic outcomes of immediately restored IIP implants, in comparison to
those immediately placed but restored in a delayed approach.
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| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Enrolling by invitation |
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||
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Phase 4 | |
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