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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03582995
Other study ID # 18.0467
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 23, 2018
Est. completion date April 30, 2021

Study information

Verified date June 2021
Source University of Louisville
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The study will consist of a randomized controlled clinical study trial comparing the results of coronally positioned flap with AlloDerm GBR plus bovine derived xenograft versus coronally positioned tunnel with AlloDerm GBR plus bovine derived xenograft in approximately 30 patients (15 per group). All materials used in the study are FDA approved.


Description:

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Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Flap Surgery for root coverage with Alloderm and xenograft
A coronally positioned FLAP technique with AlloDerm® GBR and osseous xenograft will be used for root coverage
Tunnel Surgery for root coverage with Alloderm and xenograft
A coronally positioned TUNNEL technique with AlloDerm® GBR and osseous xenograft will be used for root coverage.

Locations

Country Name City State
United States Graduate Periodontics, UofL School of Dentistry Louisville Kentucky

Sponsors (1)

Lead Sponsor Collaborator
University of Louisville

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Percentage of root coverage Initial and final recession will be measured from the cementoenamel junction to the gingival margin in millimeters. Root coverage will be determined by the amount of initial recession minus the final recession. Percent root coverage will be determined by root coverage divided by initial recession, multiplied by 100 4 months
Secondary Tissue thickness The thickness of the gingival tissue will be 4 months
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