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Evaluation of Healing at Molar Extraction Sites With and Without Ridge Preservation

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ClinicalTrials.gov Identifier: NCT02543398
Recruitment Status : Completed
First Posted : September 7, 2015
Results First Posted : November 1, 2017
Last Update Posted : June 28, 2018
Sponsor:
Collaborator:
Osteogenics Biomedical
Information provided by (Responsible Party):
The University of Texas Health Science Center at San Antonio

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Loss of Teeth Due to Extraction
Intervention Procedure: Ridge preservation
Enrollment 52
Recruitment Details Location: Graduate Periodontics clinic at the University of Texas Health Science Center at San Antonio (UTHSCSA), San Antonio, Texas Date: January 2014 to May 2015
Pre-assignment Details  
Arm/Group Title Ridge Preservation No Ridge Preservation
Hide Arm/Group Description

The molar extraction socket is grafted with FDA approved materials, which includes a bone graft material derived from human donors (enCore®, Osteogenics biomedical, Lubbock, TX) and a membrane (like a thin sheet of paper) covering the grafted extraction socket. The membrane used will need to be removed at a later point since it is non-resorbable (it will not “dissolve” by itself). This membrane is made of dense polytetrafluoroethylene (dPTFE) (Cytoplast™, Osteogenics biomedical, Lubbock, TX). The procedure is called “Ridge preservation”

Ridge preservation: Ridge preservation is a procedure which consists in grafting the tooth extraction socket with a bone grafting material and cover the site with a membrane to protect the site.

The molar extraction socket is left to heal by itself without any grafting material or membrane, i.e. “Spontaneous Healing” (No ridge preservation is performed)

Ridge preservation: Ridge preservation is a procedure which consists in grafting the tooth extraction socket with a bone grafting material and cover the site with a membrane to protect the site.

Period Title: Overall Study
Started 20 20
Completed 20 20
Not Completed 0 0
Arm/Group Title Ridge Preservation No Ridge Preservation Total
Hide Arm/Group Description

The molar extraction socket is grafted with FDA approved materials, which includes a bone graft material derived from human donors (enCore®, Osteogenics biomedical, Lubbock, TX) and a membrane (like a thin sheet of paper) covering the grafted extraction socket. The membrane used will need to be removed at a later point since it is non-resorbable (it will not “dissolve” by itself). This membrane is made of dense polytetrafluoroethylene (dPTFE) (Cytoplast™, Osteogenics biomedical, Lubbock, TX). The procedure is called “Ridge preservation”

Ridge preservation: Ridge preservation is a procedure which consists in grafting the tooth extraction socket with a bone grafting material and cover the site with a membrane to protect the site.

The molar extraction socket is left to heal by itself without any grafting material or membrane, i.e. “Spontaneous Healing” (No ridge preservation is performed)

Ridge preservation: Ridge preservation is a procedure which consists in grafting the tooth extraction socket with a bone grafting material and cover the site with a membrane to protect the site.

Total of all reporting groups
Overall Number of Baseline Participants 20 20 40
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 20 participants 20 participants 40 participants
54.1  (11.5) 53.3  (10.7) 53.6  (11.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants 20 participants 40 participants
Female
7
  35.0%
7
  35.0%
14
  35.0%
Male
13
  65.0%
13
  65.0%
26
  65.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 20 participants 20 participants 40 participants
20
 100.0%
20
 100.0%
40
 100.0%
1.Primary Outcome
Title Radiographic Bone Changes
Hide Description The width and the height of the alveolar ridge will be measured (in mm) on the initial (i.e. following tooth extraction) Cone Beam CT and on the CBCT taken prior to implant placement (i.e. 3 months after tooth extraction)
Time Frame 3 months after tooth extraction
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Ridge Preservation No Ridge Preservation
Hide Arm/Group Description:

The molar extraction socket is grafted with FDA approved materials, which includes a bone graft material derived from human donors (enCore®, Osteogenics biomedical, Lubbock, TX) and a membrane (like a thin sheet of paper) covering the grafted extraction socket. The membrane used will need to be removed at a later point since it is non-resorbable (it will not “dissolve” by itself). This membrane is made of dense polytetrafluoroethylene (dPTFE) (Cytoplast™, Osteogenics biomedical, Lubbock, TX). The procedure is called “Ridge preservation”

Ridge preservation: Ridge preservation is a procedure which consists in grafting the tooth extraction socket with a bone grafting material and cover the site with a membrane to protect the site.

The molar extraction socket is left to heal by itself without any grafting material or membrane, i.e. “Spontaneous Healing” (No ridge preservation is performed)

Ridge preservation: Ridge preservation is a procedure which consists in grafting the tooth extraction socket with a bone grafting material and cover the site with a membrane to protect the site.

Overall Number of Participants Analyzed 20 20
Mean (Standard Error)
Unit of Measure: millimeter
Bone height change -1.12  (1.60) -2.60  (2.06)
Bone width change -1.16  (1.97) -.158  (2.23)
Time Frame Data were collected until study completion that is when the patient received their dental implant
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Ridge Preservation No Ridge Preservation
Hide Arm/Group Description

The molar extraction socket is grafted with FDA approved materials, which includes a bone graft material derived from human donors (enCore®, Osteogenics biomedical, Lubbock, TX) and a membrane (like a thin sheet of paper) covering the grafted extraction socket. The membrane used will need to be removed at a later point since it is non-resorbable (it will not “dissolve” by itself). This membrane is made of dense polytetrafluoroethylene (dPTFE) (Cytoplast™, Osteogenics biomedical, Lubbock, TX). The procedure is called “Ridge preservation”

Ridge preservation: Ridge preservation is a procedure which consists in grafting the tooth extraction socket with a bone grafting material and cover the site with a membrane to protect the site.

The molar extraction socket is left to heal by itself without any grafting material or membrane, i.e. “Spontaneous Healing” (No ridge preservation is performed)

Ridge preservation: Ridge preservation is a procedure which consists in grafting the tooth extraction socket with a bone grafting material and cover the site with a membrane to protect the site.

All-Cause Mortality
Ridge Preservation No Ridge Preservation
Affected / at Risk (%) Affected / at Risk (%)
Total   0/20 (0.00%)   0/20 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Ridge Preservation No Ridge Preservation
Affected / at Risk (%) Affected / at Risk (%)
Total   0/20 (0.00%)   0/20 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Ridge Preservation No Ridge Preservation
Affected / at Risk (%) Affected / at Risk (%)
Total   0/20 (0.00%)   0/20 (0.00%) 
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: Guy Huynh-Ba
Organization: UTHSCSA Periodontics
Phone: 2105673569
Responsible Party: The University of Texas Health Science Center at San Antonio
ClinicalTrials.gov Identifier: NCT02543398     History of Changes
Other Study ID Numbers: HSC20130470H
First Submitted: August 20, 2015
First Posted: September 7, 2015
Results First Submitted: May 19, 2017
Results First Posted: November 1, 2017
Last Update Posted: June 28, 2018