We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 50 of 3261 for:    Louisville

Ridge Preservation Comparing an Intrasocket Graft Alone to an Intrasocket Graft Plus a Facial Overlay Graft

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.
ClinicalTrials.gov Identifier: NCT01431131
Recruitment Status : Completed
First Posted : September 9, 2011
Results First Posted : January 31, 2017
Last Update Posted : January 31, 2017
Sponsor:
Information provided by (Responsible Party):

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Treatment
Condition: Clinical Efficacy
Interventions: Procedure: Intrasocket graft
Procedure: Intrasocket plus facial overlay graft

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
The study was conducted between September 2011 and July 2012 in the Graduate Periodontics clinic at the University of Louisville School of Dentistry.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Intrasocket Graft Positive control, an intrasocket cancellous allograft is placed
Intrasocket Plus Facial Overlay Graft Intrasocket cancellous allograft plus a facial overlay bovine xenograft

Participant Flow:   Overall Study
    Intrasocket Graft   Intrasocket Plus Facial Overlay Graft
STARTED   12   12 
COMPLETED   12   12 
NOT COMPLETED   0   0 



  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
Intrasocket Graft Positive control, an intrasocket cancellous allograft was placed
Intrasocket Plus Facial Overlay Graft Intrasocket cancellous allograft plus a facial overlay bovine xenograft
Total Total of all reporting groups

Baseline Measures
   Intrasocket Graft   Intrasocket Plus Facial Overlay Graft   Total 
Overall Participants Analyzed 
[Units: Participants]
 12   12   24 
Age 
[Units: Participants]
Count of Participants
     
<=18 years      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      10  83.3%      10  83.3%      20  83.3% 
>=65 years      2  16.7%      2  16.7%      4  16.7% 
Age 
[Units: Years]
Mean (Standard Deviation)
 52  (16)   58  (11)   55  (14) 
Gender 
[Units: Participants]
Count of Participants
     
Female      8  66.7%      5  41.7%      13  54.2% 
Male      4  33.3%      7  58.3%      11  45.8% 
Region of Enrollment 
[Units: Participants]
     
United States   12   12   24 


  Outcome Measures

1.  Primary:   Horizontal Ridge Dimension   [ Time Frame: Baseline and 4 months ]

2.  Secondary:   Histologic Healing of the Osseous Graft   [ Time Frame: 4 months ]


  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.

1 patient in the Intrasocket plus facial overlay graft group was excluded as an outlier. There was a large amount of bone gain and this skewed the data.



  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: Dr. 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: NCT01431131     History of Changes
Other Study ID Numbers: 11.0352
First Submitted: September 7, 2011
First Posted: September 9, 2011
Results First Submitted: July 7, 2013
Results First Posted: January 31, 2017
Last Update Posted: January 31, 2017