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

Jaw, Edentulous, Partially Clinical Trial

— 3i  

Official title:

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

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT02021331
• Other study ID #: HUM00041254
• Status: Suspended
• Phase: Phase 3
• First received: December 13, 2013
• Last updated: February 14, 2016
• Start date: January 2013
• Est. completion date: January 2017

Study information

• Verified date: February 2016
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 30
• Est. completion date: January 2017
• Est. primary completion date: January 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 79 Years

Eligibility

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.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Jaw, Edentulous
• Jaw, Edentulous, Partially
• Mouth, Edentulous

Intervention

Device:
• immediate implant placement without provisionalization

• immediate implant placement with immediate provisionalization

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
University of Michigan

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Bony dimensional changes	Measurements will be based off of standardized x-rays and CBCT.	Baseline, 6mo & 12mo after baseline	No
Primary	Soft tissue diemensional change	Tissue thickness will be measured from the digital impression and CBCT data from the hard tissue.	Baseline, 12mo after baseline	No
Secondary	Implant survival	Checking to make sure the implant is stable.	2wk, 4wk, 6wk, 3mo, 6mo, 12mo	No