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Implant Placement and Simultaneous Soft Tissue Grafting With Single or Double Layers of Acellular Dermal Matrix

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ClinicalTrials.gov Identifier: NCT01902056
Recruitment Status : Completed
First Posted : July 17, 2013
Last Update Posted : July 17, 2013
Sponsor:
Information provided by (Responsible Party):
Henry Greenwell, University of Louisville

July 7, 2013
July 17, 2013
July 17, 2013
November 2012
June 2013   (Final data collection date for primary outcome measure)
Soft tissue thickness. [ Time Frame: 4 months ]
Determining the soft tissue thickness using a tissue probe.
Same as current
No Changes Posted
Not Provided
Not Provided
Not Provided
Not Provided
 
Implant Placement and Simultaneous Soft Tissue Grafting With Single or Double Layers of Acellular Dermal Matrix
Implant Placement and Simultaneous Soft Tissue Grafting With Single or Double Layers of Acellular Dermal Matrix: A Randomized, Controlled Clinical Tria.
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.
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 soft tissue thickness.
Interventional
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Clinical Efficacy
  • Procedure: One layer allograft
    The acellular dermal matrix was placed on the facial surface.
    Other Name: One layer of acellular dermal matrix (Alloderm).
  • Procedure: Two layer allograft
    The acellular dermal matrix was placed on the facial surface.
    Other Name: Two layers of acellular dermal matrix (Alloderm).
  • Active Comparator: one layer allograft
    One layer allograft as a positive control
    Intervention: Procedure: One layer allograft
  • Experimental: Two layer allograft
    Two layer allograft as the test group.
    Intervention: Procedure: Two layer allograft
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
26
Same as current
June 2013
June 2013   (Final data collection date for primary outcome measure)

Inclusion Criteria: The inclusion criteria were;

  1. one edentulous site bordered by 2 teeth in the maxilla or mandible from first molar to first molar treatment planned to receive an implant
  2. at least 18 years of age
  3. must sign the informed consent -

Exclusion Criteria: The exclusion criteria included:

  1. uncontrolled diabetes, immune disease, or any systemic disease that significantly affects the periodontium
  2. previous head and neck radiation
  3. oral bisphosphonates for > 3 years or any IV bisphosphonates
  4. smoking > 1/2 pack per day or other tobacco habits that might interfere with soft tissue healing
  5. requirement for prophylactic antibiotics
  6. allergies to any medication or material used in the study, or that would adversely affect study procedures
  7. chemotherapy in the previous 12 months
  8. psychological problems that would interfere with treatment
  9. patients unable or unwilling to sign the informed consent
  10. pregnancy -
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01902056
12.0330
No
Not Provided
Not Provided
Henry Greenwell, University of Louisville
University of Louisville
Not Provided
Principal Investigator: Henry Greenwell, DMD University of Louisville
University of Louisville
July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP