- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05419102
Retrospective Study of Implants With Peri-implantitis Surgically Treated Using Enamel Matrix Derivative (EMD)
June 10, 2022 updated by: Thomas G Wilson, Jr. DDS, North Dallas Dental Health
The existing records of a private practice limited to the practice of periodontology were reviewed to locate patients who had been diagnosed with peri-implantitis (failing dental implant) and had been surgically treated utilizing enamel matrix derivative (Commercially available FDA product Emdogain sold by Straumann USA).
Various clinical factors were gathered from the existing records.
Some of the factors recorded were: retention of the implant, presence of bleeding, presence of further damage, and presence of inflammation.
All patients had signed an informed consent for treatment and the anonymous use of their data for research purposes.
All HIPA requirements were followed.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
See brief summary.
Study Type
Observational
Enrollment (Actual)
34
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Texas
-
Dallas, Texas, United States, 75221
- North Dallas Dental Health
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 90 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Routine adult patients in a private periodontal practice.
Description
Inclusion Criteria:
- all adult patients of record who presented with existing peri-implantitis that was clinically deemed treatable (the implant was not considered hopeless.)
Exclusion Criteria:
- none except for routine medical contraindications for periodontal surgery
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Other
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
retention of the implant
Time Frame: 0.71 to 6.4 years
|
Determine if the implant was still present at the time of reevaluation
|
0.71 to 6.4 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
record the clinical condition of the implant at the time of reevaluation
Time Frame: 0.71 to 6.4 years
|
Multiple standard measurements of the clinical condition of the implant were recorded at the time of reevaluation
|
0.71 to 6.4 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Thomas G Wilson
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 1, 2022
Primary Completion (Actual)
May 15, 2022
Study Completion (Actual)
June 6, 2022
Study Registration Dates
First Submitted
June 10, 2022
First Submitted That Met QC Criteria
June 10, 2022
First Posted (Actual)
June 15, 2022
Study Record Updates
Last Update Posted (Actual)
June 15, 2022
Last Update Submitted That Met QC Criteria
June 10, 2022
Last Verified
June 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- EMD Implant 1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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