Status:
COMPLETED
Implant Placement and Simultaneous Soft Tissue Grafting With Single or Double Layers of Acellular Dermal Matrix
Lead Sponsor:
University of Louisville
Conditions:
Clinical Efficacy
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The purpose of this study is to compare the effect on soft tissue thickness of placing either a single or double layer of acellular dermal matrix simultaneous with dental implant placement. The hypoth...
Detailed Description
Patients must be greater that 18 years old, not pregnant, and have an edentulous space with a tooth on each side that is treatment planned to receive a dental implant. The primary outcome measure is s...
Eligibility Criteria
Inclusion
- The inclusion criteria were;
- one edentulous site bordered by 2 teeth in the maxilla or mandible from first molar to first molar treatment planned to receive an implant
- at least 18 years of age
- must sign the informed consent -
Exclusion
- The exclusion criteria included:
- uncontrolled diabetes, immune disease, or any systemic disease that significantly affects the periodontium
- previous head and neck radiation
- oral bisphosphonates for \> 3 years or any IV bisphosphonates
- smoking \> 1/2 pack per day or other tobacco habits that might interfere with soft tissue healing
- requirement for prophylactic antibiotics
- allergies to any medication or material used in the study, or that would adversely affect study procedures
- chemotherapy in the previous 12 months
- psychological problems that would interfere with treatment
- patients unable or unwilling to sign the informed consent
- pregnancy -
Key Trial Info
Start Date :
November 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2013
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT01902056
Start Date
November 1 2012
End Date
June 1 2013
Last Update
July 17 2013
Active Locations (1)
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1
Graduate Periodontics Clinic, School of Dentistry, University of Louisville
Louisville, Kentucky, United States, 40202