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Trial record 15 of 212 for:    Louisville AND placement

Ridge Preservation Comparing a PTFE Nonresorbable Membrane to a Collagen Membrane

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ClinicalTrials.gov Identifier: NCT01900964
Recruitment Status : Completed
First Posted : July 17, 2013
Last Update Posted : December 8, 2016
Sponsor:
Information provided by (Responsible Party):
Henry Greenwell, University of Louisville

Brief Summary:
A non-resorbable PTFE (teflon) membrane will be compared to a resorbable collagen membrane when used for a post-extraction ridge preservation procedure to prevent the bone loss that typically occurs. The hypothesis is that there will be no difference in the clinical and histologic results between the two membranes.

Condition or disease Intervention/treatment Phase
Clinical Efficacy Procedure: PTFE membrane Procedure: Collagen membrane Not Applicable

Detailed Description:

Patient Selection 30 patients will be selected that meet the following criteria:

Inclusion Criteria

  1. Have one non-molar tooth requiring extraction that will be replaced by a dental implant. The site must be bordered by at least one tooth.
  2. Healthy male or female who is at least 18 years old.
  3. Patients must sign an informed consent approved by the University of Louisville Human Studies Committee.

Exclusion Criteria

  1. Patients with debilitating systemic diseases, or diseases that have a clinically significant effect on the periodontium.
  2. Presence or history of osteonecrosis of jaws.
  3. Patients who are currently taking IV bisphosphonates or who had IV treatment with bisphosphonates irrespective of duration.
  4. Patients who have been treated with oral bisphosphonates for more than three years.
  5. Patients with an allergy to any material or medication used in the study.
  6. Patients who need prophylactic antibiotics.
  7. Previous head and neck radiation therapy.
  8. Chemotherapy in the previous 12 months.
  9. Patients on long term NSAID or steroid therapy.
  10. Pregnant patients.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Ridge Preservation Comparing the Clinical and Histologic Healing of a PTFE Non-resorbable vs. a Collagen Membrane With an Intrasocket Mineralized Cancellous Allograft Plus a Facial Overlay Bovine Xenograft.
Study Start Date : October 2012
Actual Primary Completion Date : November 2013
Actual Study Completion Date : November 2013

Resource links provided by the National Library of Medicine

Drug Information available for: Collagen

Arm Intervention/treatment
Active Comparator: PTFE membrane
A non-resorbable PTFE (polytetrafluoroethylene) membrane will be used as a positive control treatment.
Procedure: PTFE membrane
The non-resorbable PTFE barrier membrane will be surgically placed in conjunction with a ridge preservation procedure.

Experimental: Collagen membrane
A resorbable collagen membrane will be used in the test group.
Procedure: Collagen membrane
A resorbable collagen membrane is surgically placed in conjunction with a ridge preservation procedure.




Primary Outcome Measures :
  1. Crestal ridge width [ Time Frame: Time 4 months ]
    The crestal ridge width will be measured with a digital caliper at the baseline exam and at the 4 month examination.


Secondary Outcome Measures :
  1. Percent vital bone [ Time Frame: Time 4 months ]
    A trephine core will be taken at 4 months immediately prior to implant placement from the implant osteotomy site.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Have one non-molar tooth requiring extraction that will be replaced by a dental implant. The site must be bordered by at least one tooth.
  2. Healthy male or female who is at least 18 years old.
  3. Patients must sign an informed consent approved by the University of Louisville Human Studies Committee.

Exclusion Criteria:

  1. Patients with debilitating systemic diseases, or diseases that have a clinically significant effect on the periodontium.
  2. Presence or history of osteonecrosis of jaws.
  3. Patients who are currently taking IV bisphosphonates or who had IV treatment with bisphosphonates irrespective of duration.
  4. Patients who have been treated with oral bisphosphonates for more than three years.
  5. Patients with an allergy to any material or medication used in the study.
  6. Patients who need prophylactic antibiotics.
  7. Previous head and neck radiation therapy.
  8. Chemotherapy in the previous 12 months.
  9. Patients on long term NSAID (nonsteroidal anti-inflammatory drug) or steroid therapy.
  10. Pregnant patients. -

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01900964


Locations
United States, Kentucky
Graduate Periodontics Clinic, University of Louisville
Louisvile, Kentucky, United States, 40202
Sponsors and Collaborators
University of Louisville
Investigators
Principal Investigator: Henry Greenwell, DMD University of Louisville

Responsible Party: Henry Greenwell, Professor, University of Louisville
ClinicalTrials.gov Identifier: NCT01900964     History of Changes
Other Study ID Numbers: 12.0455
First Posted: July 17, 2013    Key Record Dates
Last Update Posted: December 8, 2016
Last Verified: May 2014

Keywords provided by Henry Greenwell, University of Louisville:
Regeneration
Bone regeneration
Grafting, Bone
Allograft
Xenograft