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Implant Placement With Simultaneous Gum Grafting

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ClinicalTrials.gov Identifier: NCT01431144
Recruitment Status : Completed
First Posted : September 9, 2011
Results First Posted : September 13, 2013
Last Update Posted : February 1, 2017
Sponsor:
Collaborator:
BioHorizons, Inc.
Information provided by (Responsible Party):
Henry Greenwell, University of Louisville

September 7, 2011
September 9, 2011
July 7, 2013
September 13, 2013
February 1, 2017
September 2011
June 2013   (Final data collection date for primary outcome measure)
Soft Tissue Thickness Over the Implant [ Time Frame: 1 year ]
Soft tissue thickness at the facial osseous crest.
Soft Tissue Thickness Over the Implant [ Time Frame: 1 year ]
Complete list of historical versions of study NCT01431144 on ClinicalTrials.gov Archive Site
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Implant Placement With Simultaneous Gum Grafting
The Effect of Implant Placement and Simultaneous Soft Tissue Augmentation in the Esthetic Zone Using Either Connective Tissue Autograft or Acellular Dermal Matrix Allograft on Peri-implant Hard and Soft Tissue Healing
This study is a comparison of implant placed and simultaneously grafted with either autogenous connective tissue or a connective tissue allograft. The objective is to determine the change in soft tissue thickness and determine if a better result is obtained with the autograft or the allograft. The hypothesis is that there will be no difference in soft tissue thickness over the implant between the autograft and the allograft technique.
Not Provided
Interventional
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Edentulous
  • Procedure: connective tissue autograft
    A connective tissue autograft is harvested from the palate and grafted at the site of implant placement on the facial surface.
  • Procedure: connective tissue allograft
    An acellular dermal matrix allograft (Alloderm, BioHorizons, Inc, Birmingham, AL, USA) is grafted at the site of implant placement on the facial surface.
  • Active Comparator: Connective tissue autograft
    A connective tissue autograft harvested from the palate was grafted onto the facial of a simultaneously placed dental implant and soft tissue thickness was measured at baseline and Time 4.
    Intervention: Procedure: connective tissue autograft
  • Experimental: connective tissue allograft
    An acellular dermal matrix allograft was grafted on the facial surface of a simultaneously placed dental implant and soft tissue thickness was measured at baseline and Time 4.
    Intervention: Procedure: connective tissue allograft
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
27
30
June 2013
June 2013   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • One edentulous site bordered by 2 teeth needing a dental implant

Exclusion Criteria:

  • Systemic diseases that affect the periodontium
  • Previous head and neck radiation
  • Smoking more that 1/2 pack per day
  • Requires prophylactic antibiotics
  • Allergy to meds used in study
  • Previous chemotherapy
  • Pregnancy
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01431144
11.0355
No
Not Provided
Not Provided
Henry Greenwell, University of Louisville
University of Louisville
BioHorizons, Inc.
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