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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

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Edentulous Procedure: connective tissue autograft Procedure: connective tissue allograft Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 27 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : September 2011
Actual Primary Completion Date : June 2013
Actual Study Completion Date : June 2013
Arms and Interventions
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Arm Intervention/treatment
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.
 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.
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.
 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.


Outcome Measures
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Primary Outcome Measures :
  1. Soft Tissue Thickness Over the Implant [ Time Frame: 1 year ]
    Soft tissue thickness at the facial osseous crest.


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

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
Contacts and Locations
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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): NCT01431144


Locations
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United States, Kentucky
Graduate Periodontics Clinic, School of Dentistry, University of Louisville
Louisville, Kentucky, United States, 40202
Sponsors and Collaborators
University of Louisville
BioHorizons, Inc.
Investigators
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Principal Investigator: Henry Greenwell, DMD University of Louisville
More Information
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Responsible Party: Henry Greenwell, Principal Investigator, University of Louisville
ClinicalTrials.gov Identifier: NCT01431144    
Other Study ID Numbers: 11.0355
First Posted: September 9, 2011    Key Record Dates
Results First Posted: September 13, 2013
Last Update Posted: February 1, 2017
Last Verified: July 2013
Keywords provided by Henry Greenwell, University of Louisville:
soft tissue thickness
dental implant
soft tissue recession
implant exposure
Additional relevant MeSH terms:
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Mouth, Edentulous
Mouth Diseases
Stomatognathic Diseases
Tooth Diseases