Implant Placement With Simultaneous Gum Grafting

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01431144
Recruitment Status : Completed
First Posted : September 9, 2011
Results First Posted : September 13, 2013
Last Update Posted : February 1, 2017
BioHorizons, Inc.
Information provided by (Responsible Party):
Henry Greenwell, University of Louisville

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Treatment
Condition: Edentulous
Interventions: Procedure: connective tissue autograft
Procedure: connective tissue allograft

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
27 patients were entered, 13 for the test allograft group and 14 for the positive control connective tissue autograft group

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
There were no exclusions prior to assignment or treatment.

Reporting Groups
Connective Tissue Allograft A connective tissue allograft was placed simultaneously with dental implant placement and soft tissue thickness was measured at baseline and Time 4.
Connective Tissue Autograft A connective tissue autograft was placed simultaneously with dental implant placement and soft tissue thickness was measured at baseline and Time 4.

Participant Flow:   Overall Study
    Connective Tissue Allograft   Connective Tissue Autograft
STARTED   13   14 
COMPLETED   11   14 
Implant mobility and removal                2                0 

  Baseline Characteristics

  Outcome Measures

1.  Primary:   Soft Tissue Thickness Over the Implant   [ Time Frame: 1 year ]

  Serious Adverse Events

  Other Adverse Events

  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
There were no adverse events. There were 2 cases of implant mobility and these was treated as a potential expected complication and handled with routine clinical practice guidelines.

  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact:  
Name/Title: Henry Greenwell, Principal Investigator
Organization: University of Louisville
phone: 502-852-6928

Responsible Party: Henry Greenwell, University of Louisville Identifier: NCT01431144     History of Changes
Other Study ID Numbers: 11.0355
First Submitted: September 7, 2011
First Posted: September 9, 2011
Results First Submitted: July 7, 2013
Results First Posted: September 13, 2013
Last Update Posted: February 1, 2017