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

NCT ID: NCT02021331

Last Updated: 2017-07-11

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 5 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-12-31
• Study Completion Date: 2016-04-30

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.

Conditions

Jaw, Edentulous, Partially

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

immediate implant placement without provisionalization

Intervention Type: DEVICE

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.

Group Type: EXPERIMENTAL

immediate implant placement with immediate provisionalization

Intervention Type: DEVICE

Interventions

immediate implant placement without provisionalization

Intervention Type: DEVICE

immediate implant placement with immediate provisionalization

Intervention Type: DEVICE

Other Intervention Names

BIOMET 3i Prevail Nanotite Certain - dental implant; Encode abutment; BIOMET 3i Prevail Nanotite Certain - dental implant; Encode abutment

Eligibility Criteria

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

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 79 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Michigan

OTHER

Sponsor Role: lead

Responsible Party

Robert M. Eber

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University of Michigan

Ann Arbor, Michigan, United States

Countries

United States

Other Identifiers

HUM00041254

Identifier Type: -

Identifier Source: org_study_id