Clinical Trial: The Effect of Immediate Implant Placement and Provisionalization in the Esthetic Zone

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

Official Title: The Effect of Immediate Implant Placement and Provisionalization in The Esthetic Zone: A Randomized Clinical Trial

Brief Summary: The purpose of this study is to compare two different techniques of placing dental implants: 1) removing the tooth and placing the implant immediately and 2) removing the tooth and placing both the implant and a temporary crown immediately. 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 implant placement technique for their patients.

Detailed Summary:

To qualify, patients must be between 18 to 79 years old, in good health, have a tooth in the upper jaw (except molars) that needs to be extracted, and able and willing to return to the University of Michigan Dental School for all follow-up appointments (8 follow-up visits over a period of 12 months). Sufficient number of natural teeth and/or replacements to provide a stable occlusion as determined by the investigator

Patients will be excluded for any of the following conditions: Women who are pregnant or plan to become pregnant, an existing implant adjacent to the area of study, current smoker or quit smoking less than one year ago, antibiotic therapy for more than two weeks within 3 months of baseline, need for antibiotics prior to dental treatment (due to prosthetic joint replacement or other medical condition), chronic use of medications known to affect the gum tissues (calcium channel blocker (less than 6 months, or over 6 months and have experienced overgrowth of your gums), anticonvulsants, immunosuppressive drugs, nonsteroidal anti-inflammatory medications...), current orthodontic treatment, or active periodontal treatment. Participants must inform the investigators if they are enrolled in any other studies because it may becloud them from participation in this study.


Sponsor: University of Michigan

Current Primary Outcome: Soft Tissue Diemensional Change [ Time Frame: Baseline, 12mo after baseline ]

Tissue thickness will be measured from the digital impression and CBCT data from the hard tissue.


Original Primary Outcome: Same as current

Current Secondary Outcome: Implant Survival [ Time Frame: 2wk, 4wk, 6wk, 3mo, 6mo, 12mo ]

Checking to make sure the implant is stable.


Original Secondary Outcome: Same as current

Information By: University of Michigan

Dates:
Date Received: December 13, 2013
Date Started: December 2012
Date Completion:
Last Updated: March 20, 2017
Last Verified: March 2017