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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

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.

Condition or disease Intervention/treatment Phase
Clinical Efficacy Procedure: One layer allograft Procedure: Two layer allograft Not Applicable

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 soft tissue thickness.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 26 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Implant Placement and Simultaneous Soft Tissue Grafting With Single or Double Layers of Acellular Dermal Matrix: A Randomized, Controlled Clinical Tria.
Study Start Date : November 2012
Actual Primary Completion Date : June 2013
Actual Study Completion Date : June 2013

Arm Intervention/treatment
Active Comparator: one layer allograft
One layer allograft as a positive control
Procedure: One layer allograft
The acellular dermal matrix was placed on the facial surface.
Other Name: One layer of acellular dermal matrix (Alloderm).
Experimental: Two layer allograft
Two layer allograft as the test group.
Procedure: Two layer allograft
The acellular dermal matrix was placed on the facial surface.
Other Name: Two layers of acellular dermal matrix (Alloderm).



Primary Outcome Measures :
  1. Soft tissue thickness. [ Time Frame: 4 months ]
    Determining the soft tissue thickness using a tissue probe.



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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 -

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01902056


Locations
United States, Kentucky
Graduate Periodontics Clinic, School of Dentistry, University of Louisville
Louisville, Kentucky, United States, 40202
Sponsors and Collaborators
University of Louisville
Investigators
Principal Investigator: Henry Greenwell, DMD University of Louisville

Responsible Party: Henry Greenwell, Professor, University of Louisville
ClinicalTrials.gov Identifier: NCT01902056     History of Changes
Other Study ID Numbers: 12.0330
First Posted: July 17, 2013    Key Record Dates
Last Update Posted: July 17, 2013
Last Verified: July 2013

Keywords provided by Henry Greenwell, University of Louisville:
allograft
acellular dermal matrix
Alloderm