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Completed

NCT Number: NCT01900964

Ridge Preservation Comparing a PTFE Nonresorbable Membrane to a Collagen Membrane

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.

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Key information

Conditions

Clinical Efficacy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Graduate Periodontics Clinic, University of Louisville

Louisvile, Kentucky, 40202, United States

About this study

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

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 or steroid therapy.
  • Pregnant patients.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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. -

Treatment and study plan

PTFE membrane

Procedure

The non-resorbable PTFE barrier membrane will be surgically placed in conjunction with a ridge preservation procedure.

Collagen membrane

Procedure

A resorbable collagen membrane is surgically placed in conjunction with a ridge preservation procedure.

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

University of Louisville

Other

Registry information

Official study 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.

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Jul 17, 2013
Registry last updated
Dec 8, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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