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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 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


  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
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.
Total Total of all reporting groups

Baseline Measures
   Connective Tissue Allograft   Connective Tissue Autograft   Total 
Overall Participants Analyzed 
[Units: Participants]
 13   14   27 
Age 
[Units: Participants]
Count of Participants
     
<=18 years      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      10  76.9%      9  64.3%      19  70.4% 
>=65 years      3  23.1%      5  35.7%      8  29.6% 
Age 
[Units: Years]
Mean (Standard Deviation)
 46  (21)   57  (10)   52  (16) 
Gender 
[Units: Participants]
Count of Participants
     
Female      7  53.8%      9  64.3%      16  59.3% 
Male      6  46.2%      5  35.7%      11  40.7% 
Region of Enrollment 
[Units: Participants]
     
United States   13   14   27 


  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
e-mail: henry.greenwell@louisville.edu



Responsible Party: Henry Greenwell, University of Louisville
ClinicalTrials.gov 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