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

Sponsor
University of Louisville (Other)
Overall Status
Completed
CT.gov ID
NCT01902056
Collaborator
(none)
26
Enrollment
1
Location
2
Arms
7
Duration (Months)
3.7
Patients Per Site Per Month

Study Details

Study Description

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
  • Procedure: One layer allograft
  • Procedure: Two layer allograft
 N/A

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 Design

Study Type:
Interventional
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 :
Nov 1, 2012
Actual Primary Completion Date :
Jun 1, 2013
Actual Study Completion Date :
Jun 1, 2013

Arms and Interventions

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 Names:
  • 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 Names:
  • Two layers of acellular dermal matrix (Alloderm).

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Soft tissue thickness. [4 months]

      Determining the soft tissue thickness using a tissue probe.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes

    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 -

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Henry Greenwell, Professor, University of Louisville
    ClinicalTrials.gov Identifier:
    NCT01902056
    Other Study ID Numbers:
    • 12.0330
    First Posted:
    Jul 17, 2013
    Last Update Posted:
    Jul 17, 2013
    Last Verified:
    Jul 1, 2013
    Keywords provided by Henry Greenwell, Professor, University of Louisville
    allograft
    acellular dermal matrix
    Alloderm

    Study Results

    No Results Posted as of Jul 17, 2013