Implant Placement and Simultaneous Soft Tissue Grafting With Single or Double Layers of Acellular Dermal Matrix
1 other identifier
interventional
26
1 country
1
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 hypothesis is that 2 layers of acellular dermal matrix will produce thicker tissues that one layer.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Nov 2012
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2013
CompletedFirst Submitted
Initial submission to the registry
July 7, 2013
CompletedFirst Posted
Study publicly available on registry
July 17, 2013
CompletedJuly 17, 2013
July 1, 2013
7 months
July 7, 2013
July 15, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Soft tissue thickness.
Determining the soft tissue thickness using a tissue probe.
4 months
Study Arms (2)
one layer allograft
ACTIVE COMPARATOROne layer allograft as a positive control
Two layer allograft
EXPERIMENTALTwo layer allograft as the test group.
Interventions
The acellular dermal matrix was placed on the facial surface.
The acellular dermal matrix was placed on the facial surface.
Eligibility Criteria
You may qualify if:
- 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 -
You may not qualify if:
- 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 -
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Graduate Periodontics Clinic, School of Dentistry, University of Louisville
Louisville, Kentucky, 40202, United States
MeSH Terms
Interventions
Study Officials
- PRINCIPAL INVESTIGATOR
Henry Greenwell, DMD
University of Louisville
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
July 7, 2013
First Posted
July 17, 2013
Study Start
November 1, 2012
Primary Completion
June 1, 2013
Study Completion
June 1, 2013
Last Updated
July 17, 2013
Record last verified: 2013-07