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Ridge Augmentation Without Primary Closure

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ClinicalTrials.gov Identifier: NCT01901783
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

July 12, 2013
July 17, 2013
December 8, 2016
September 2013
June 2014   (Final data collection date for primary outcome measure)
Crestal ridge width [ Time Frame: 4 months ]
The ridge width at the crest will be compared between the two treatment groups.
Same as current
Complete list of historical versions of study NCT01901783 on ClinicalTrials.gov Archive Site
Percent vital bone [ Time Frame: 4 months ]
The percent vital bone will be compared between the two treatment groups.
Same as current
Not Provided
Not Provided
 
Ridge Augmentation Without Primary Closure
Ridge Augmentation Comparing the Clinical and Histologic Healing of a Cancellous Block Allograft Plus a Barrier Membrane With and Without Primary Closure
This study is designed to compare the clinical and histologic results of ridge augmentation with and without primary closure over the barrier membrane. The hypothesis is that there will be no difference in crestal ridge width between the two groups.

A maximum of 30 patients will be selected that meet the following criteria:

Inclusion Criteria

  1. At least a one tooth area with a ridge defect, treatment planned to receive a dental implant. The site must be bordered by at least one tooth.
  2. Healthy person that is at least 18 years old.
  3. Patient understands and signs an informed consent approved by the University of Louisville Human Studies Committee.

Exclusion Criteria

  1. Patients with debilitating systemic diseases, diseases that affect the periodontium, or psychological problems that would interfere with treatment.
  2. Previous head and neck radiation or chemotherapy within the previous 12 months.
  3. Patients with known allergy to any of the materials that will be used in the study.
  4. Smokers.
  5. Patients who need prophylactic antibiotics prior to dental procedures.
  6. Patients on long-term steroid therapy or oral bisphosphonates > 3 years or any IV biosphosphonates.
  7. Patients who are pregnant.
Interventional
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Alveolar Ridge Augmentation
  • Procedure: With primary closure
    A cancellous block allograft will be placed for ridge augmentation and covered with a barrier membrane. The soft tissue will be primarily closed over the membrane.
    Other Name: Primary soft tissue closure over the membrane.
  • Procedure: Without primary closure
    A cancellous block allograft will be placed for ridge augmentation and covered with a barrier membrane. The soft tissue will not be primarily closed over the membrane.
    Other Name: No primary soft tissue closure over the membrane.
  • Active Comparator: With primary closure
    The ridge augmentation graft will be covered with a barrier membrane and the soft tissue will be primarily closed.
    Intervention: Procedure: With primary closure
  • Experimental: Without primary closure
    The ridge augmentation graft will be covered with a barrier membrane and the soft tissue will not be primarily closed.
    Intervention: Procedure: Without primary closure
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
18
30
June 2014
June 2014   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  1. At least a one tooth area with a ridge defect, treatment planned to receive a dental implant. The site must be bordered by at least one tooth.
  2. Healthy person that is at least 18 years old.
  3. Patient understands and signs an informed consent approved by the University of Louisville Human Studies Committee.

Exclusion Criteria:

  1. Patients with debilitating systemic diseases, diseases that affect the periodontium, or psychological problems that would interfere with treatment.
  2. Previous head and neck radiation or chemotherapy within the previous 12 months.
  3. Patients with known allergy to any of the materials that will be used in the study.
  4. Smokers.
  5. Patients who need prophylactic antibiotics prior to dental procedures.
  6. Patients on long-term steroid therapy or oral bisphosphonates > 3 years or any IV biosphosphonates.
  7. Patients who are pregnant.
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
 
 
NCT01901783
13.0331
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