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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):
Henry Greenwell, University of Louisville

July 12, 2013
July 23, 2013
December 8, 2016
September 2013
July 2014   (Final data collection date for primary outcome measure)
Crestal ridge width [ Time Frame: 4 months ]
The width of the ridge at the crest will be measured with a digital caliper.
Same as current
Complete list of historical versions of study NCT01905280 on ClinicalTrials.gov Archive Site
Percent vital bone [ Time Frame: 4 months ]
Percent vital bone at the graft site will be determined from a trephine core sample.
Same as current
Not Provided
Not Provided
 
Ridge Preservation Comparing 2 Membranes
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.
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.

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.
Interventional
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Alveolar Ridge Deficiency
  • 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
  • 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
  • Experimental: Acellular dermal matrix
    A ridge preservation graft will be performed and then covered using acellular dermal matrix as a membrane.
    Intervention: Procedure: Acellular dermal matrix
  • Active Comparator: Non-resorbable membrane
    A ridge preservation graft will be performed and then covered using a non-resorbable PTFE membrane.
    Intervention: Procedure: Non-resorbable membrane
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
24
30
July 2014
July 2014   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01905280
13.0330
No
Not Provided
Not Provided
Henry Greenwell, University of Louisville
University of Louisville
Not Provided
Principal Investigator: Henry Greenwell, DMD University of Louisville
University of Louisville
December 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP