Esthetic Outcomes of Immediately Placed Implants Receiving Immediate Provisionalization and Delayed Restoration
Completed · Not applicable
Conditions studied: Tooth Diseases, Tooth Extraction, Dental Implant
In brief
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.
Key facts
- Study ID
- NCT01925339
- Run by
- University of Michigan
- People needed
- 40
- Starts
- 2015-12-01
- Expected to finish
- 2018-03-15
- Last updated by the study team
- 2019-02-18
Who can join
Age: 21 and older. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Male or female, aged 21 or older
- A minimum dentition of 20 permanent teeth (including natural rooted teeth or dental implants; pontic of a fixed bridge is not considered a tooth)
- A maxillary premolar, canine, lateral incisor or central incisor with a hopeless prognosis
- Presence of adjacent teeth and enough clearance for an implant crown
- Presence of sufficient bone apical to the root apex of the hopeless tooth
You may not qualify if…
- Systemic criteria:
- Current heavy smokers (>10 cigarettes per day) or heavy smokers who quitted less than 1 year
- Pregnant or plan to get pregnant or lactating mothers
- Diseases of the immune system or any medical condition that may influence the outcome (uncontrolled diabetes (HbA1c >7), neurologic or psychiatric disorders, systemic infections, …)
- Radiation therapy in the head and neck area within 3 years
- Current use of oral bisphosphonates for >3 years
- History of IV bisphosphonates use
- Other medical conditions that may contradict an implant surgery
- Intraoral criteria:
- Area of study is adjacent to an existing implant
- Acute infection at/or adjacent to the extraction site (e.g., sinus tract, swelling, etc.)
- Observable gingival changes due to use of medications such as calcium antagonists, anticonvulsives, immunosuppressives, anti-inflammatory medications, etc.)
- Untreated deep carious lesions or defective restorations that can potentially exacerbate during the course of the experiment
- Uncontrolled periodontal disease
- Poor oral hygiene (>20% FMPS)
- CBCT criteria:
- More than 4 mm of buccal plate dehiscence is present on CBCT scans
- Intraoperative criteria:
- More than 4 mm of buccal plate dehiscence is present once the tooth is extracted
Where it is running
- University of Michigan School of Dentistry — Ann Arbor, Michigan, United States
Full record on ClinicalTrials.gov
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