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Treatment of Post-Extraction Dehisced Socket - A Case Series Study (OSTEO2)

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: NCT02980211
Recruitment Status : Completed
First Posted : December 2, 2016
Results First Posted : January 22, 2020
Last Update Posted : February 5, 2020
Sponsor:
Collaborator:
Osteogenics Biomedical
Information provided by (Responsible Party):
Gustavo Avila-Ortiz DDS, MS, PhD, University of Iowa

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Tooth Loss
Intervention Drug: Alveolar Ridge Reconstruction
Enrollment 17
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Tooth Extraction and Graft Dehisced Socket
Hide Arm/Group Description

Treatment of dehiscence defects at the time of tooth extraction using a minimally-invasive GBR technique that involves the application of a particulate bone allograft and a non-resorbable PTFE membrane.

Alveolar Ridge Reconstruction: Reconstruction of dehiscence defects in extraction sockets with a minimally invasive technique using a particulate bone allograft and a non-absorbable dense polytetrafluoroethylene (dPTFE) membrane

Period Title: Overall Study
Started 17
Completed 17
Not Completed 0
Arm/Group Title Tooth Extraction and Graft Dehisced Socket
Hide Arm/Group Description

Treatment of dehiscence defects at the time of tooth extraction using a minimally-invasive GBR technique that involves the application of a particulate bone allograft and a non-resorbable PTFE membrane.

Alveolar Ridge Reconstruction: Reconstruction of dehiscence defects in extraction sockets with a minimally invasive technique using a particulate bone allograft and a non-absorbable dense polytetrafluoroethylene (dPTFE) membrane

Overall Number of Baseline Participants 17
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 17 participants
<=18 years
0
   0.0%
Between 18 and 65 years
14
  82.4%
>=65 years
3
  17.6%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 17 participants
51.82  (13.61)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 17 participants
Female
4
  23.5%
Male
13
  76.5%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 17 participants
Hispanic or Latino
2
  11.8%
Not Hispanic or Latino
15
  88.2%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 17 participants
17
1.Primary Outcome
Title Bone Volumetric Reduction From Baseline to 20 Weeks Post-extraction
Hide Description Alveolar bone volumetric reduction from baseline to 20 weeks using CBCT scans
Time Frame Baseline and 20 weeks post-extraction
Hide Outcome Measure Data
Hide Analysis Population Description
Two of the 17 DICOM datasets could not be analyzed due to extensive scattering, therefore the final sample size for this outcome was 15
Arm/Group Title Tooth Extraction and Graft Dehisced Socket
Hide Arm/Group Description:

Treatment of dehiscence defects at the time of tooth extraction using a minimally-invasive GBR technique that involves the application of a particulate bone allograft and a non-resorbable PTFE membrane.

Alveolar Ridge Reconstruction: Reconstruction of dehiscence defects in extraction sockets with a minimally invasive technique using a particulate bone allograft and a non-absorbable dense polytetrafluoroethylene (dPTFE) membrane

Overall Number of Participants Analyzed 15
Mean (Standard Deviation)
Unit of Measure: mm3
73.26  (77.27)
Time Frame 24 weeks post-extraction
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Tooth Extraction and Graft Dehisced Socket
Hide Arm/Group Description

Treatment of dehiscence defects at the time of tooth extraction using a minimally-invasive GBR technique that involves the application of a particulate bone allograft and a non-resorbable PTFE membrane.

Alveolar Ridge Reconstruction: Reconstruction of dehiscence defects in extraction sockets with a minimally invasive technique using a particulate bone allograft and a non-absorbable dense polytetrafluoroethylene (dPTFE) membrane

All-Cause Mortality
Tooth Extraction and Graft Dehisced Socket
Affected / at Risk (%)
Total   0/17 (0.00%)    
Hide Serious Adverse Events
Tooth Extraction and Graft Dehisced Socket
Affected / at Risk (%) # Events
Total   0/17 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Tooth Extraction and Graft Dehisced Socket
Affected / at Risk (%) # Events
Total   1/17 (5.88%)    
Surgical and medical procedures   
Premature barrier membrane exfoliation  [1]  1/17 (5.88%)  1
Indicates events were collected by systematic assessment
[1]
One patient decided to remove the membrane himself between 2 and 5 weeks because it was "bothersome"
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
Layout table for Results Point of Contact information
Name/Title: Dr. Gustavo Avila-Ortiz, Professor and Chair, Department of Periodontics
Organization: University of Iowa College of Dentistry
Phone: 3193357241
EMail: gustavo-avila@uiowa.edu
Layout table for additonal information
Responsible Party: Gustavo Avila-Ortiz DDS, MS, PhD, University of Iowa
ClinicalTrials.gov Identifier: NCT02980211    
Other Study ID Numbers: 201612718
First Submitted: November 28, 2016
First Posted: December 2, 2016
Results First Submitted: December 26, 2019
Results First Posted: January 22, 2020
Last Update Posted: February 5, 2020