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Ridge Preservation Comparing 2 Membranes

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ClinicalTrials.gov Identifier: NCT01905280
Recruitment Status : Completed
First Posted : July 23, 2013
Last Update Posted : December 8, 2016
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
The purpose of this study is to compare the clinical and histologic outcomes for acellular dermal matrix and a nonresorbable membrane to determine if either provides a significant therapeutic advantage. The hypothesis is that there will be no difference in crestal ridge width between the two treatments.

Condition or disease Intervention/treatment
Alveolar Ridge Deficiency Procedure: Non-resorbable membrane Procedure: Acellular dermal matrix

Detailed Description:

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 Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 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 Membrane Versus an Acellular Dermal Matrix Allograft Plus a Facial Overaly Bovine Xenograft.
Study Start Date : September 2013
Primary Completion Date : July 2014
Study Completion Date : July 2014
Arms and Interventions

Arm Intervention/treatment
Experimental: Acellular dermal matrix
A ridge preservation graft will be performed and then covered using acellular dermal matrix as a membrane.
Procedure: Acellular dermal matrix
The ridge preservation graft will be covered with an acellular dermal matrix allograft during the surgery.
Other Name: Acellular dermal matrix allograft, Alloderm
Active Comparator: Non-resorbable membrane
A ridge preservation graft will be performed and then covered using a non-resorbable PTFE membrane.
Procedure: Non-resorbable membrane
The ridge preservation graft will be covered with a non-resorbable PTFE membrane during the surgery.
Other Name: PTFE or Cytoplast


Outcome Measures

Primary Outcome Measures :
  1. Crestal ridge width [ Time Frame: 4 months ]
    The width of the ridge at the crest will be measured with a digital caliper.


Secondary Outcome Measures :
  1. Percent vital bone [ Time Frame: 4 months ]
    Percent vital bone at the graft site will be determined from a trephine core sample.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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 or steroid therapy.
  10. Pregnant patients.
Contacts and Locations

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): NCT01905280


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

Responsible Party: Henry Greenwell, Professor, University of Louisville
ClinicalTrials.gov Identifier: NCT01905280     History of Changes
Other Study ID Numbers: 13.0330
First Posted: July 23, 2013    Key Record Dates
Last Update Posted: December 8, 2016
Last Verified: December 2016

Keywords provided by Henry Greenwell, University of Louisville:
allograft
acellular dermal matrix
alveolar ridge