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

Not Applicable

Terminated

• Conditions: Jaw, Edentulous, Partially
• Interventions: Device: immediate implant placement without provisionalization; Device: immediate implant placement with immediate provisionalization

• Registration Number: NCT02021331
• Lead Sponsor: University of Michigan

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 Description

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.

Study Timeline

• Study Start: 2012-12
• Study First Submitted: 2013-12-13
• Study First Submitted QC: 2013-12-19
• Study First Posted: 2013-12-27
• Primary Completion: 2016-04
• Study Completion: 2016-04
• Results First Submitted: 2017-03-20
• Results First Submitted QC: 2017-03-20
• Results First Posted: 2017-04-28
• Status Verified: 2017-06
• Last Update Submitted: 2017-06-08
• Last Update Posted: 2017-07-11

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 5

Inclusion Criteria

• between 18 to 79 years old
• in good health
• have a single tooth in the upper jaw (except molars) that needs to be extracted
• 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

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Exclusion Criteria

• 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
• Women who are pregnant or plan to become pregnant during the course of the study, and nursing mothers
• unstable medical condition or if you are unable to have routine dental surgery then you should not participate in this study. If you are already participating in another study, we ask that you inform the investigators because participating in more than one study may be harmful to you.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
immediate implant placement without provisionalization	immediate implant placement without provisionalization	The subject will have the tooth removed and an implant placed right away. In this arm the subject will have no temporary crown on the implant.
immediate implant placement with immediate provisionalization	immediate implant placement with immediate provisionalization	The subject will have the tooth removed and an implant placed right away. In this arm the subject will get a temporary crown on the implant.

Primary Outcome Measures

Name	Time	Method
Soft Tissue Diemensional Change	Baseline, 12mo after baseline	Tissue thickness will be measured from the digital impression and CBCT data from the hard tissue.

Secondary Outcome Measures

Name	Time	Method
Implant Survival	2wk, 4wk, 6wk, 3mo, 6mo, 12mo	Checking to make sure the implant is stable.

Trial Locations

Locations (1)

University of Michigan; 🇺🇸 Ann Arbor, Michigan, United States