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Clinical Trials/NCT01900964
NCT01900964CompletedNot Applicable

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.

University of Louisville2 sites in 1 country30 target enrollmentStarted: October 2012Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
30
Locations
2
Primary Endpoint
Crestal ridge width
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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.

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 Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • •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.
  • •Healthy male or female who is at least 18 years old.
  • •Patients must sign an informed consent approved by the University of Louisville Human Studies Committee.

Exclusion Criteria

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

Outcomes

Primary Outcomes

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 Outcomes

  • Percent vital bone(Time 4 months)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Henry Greenwell

Professor

University of Louisville

Study Sites (2)

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