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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

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Alveolar Ridge Augmentation Procedure: With primary closure Procedure: Without primary closure Not Applicable

Detailed Description:

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Ridge Augmentation Comparing the Clinical and Histologic Healing of a Cancellous Block Allograft Plus a Barrier Membrane With and Without Primary Closure
Study Start Date : September 2013
Actual Primary Completion Date : June 2014
Actual Study Completion Date : June 2014
Arms and Interventions
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Arm Intervention/treatment
Active Comparator: With primary closure
The ridge augmentation graft will be covered with a barrier membrane and the soft tissue will be primarily closed.
 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.
Experimental: Without primary closure
The ridge augmentation graft will be covered with a barrier membrane and the soft tissue will not be primarily closed.
 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.


Outcome Measures
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Primary Outcome Measures :
  1. Crestal ridge width [ Time Frame: 4 months ]
    The ridge width at the crest will be compared between the two treatment groups.


Secondary Outcome Measures :
  1. Percent vital bone [ Time Frame: 4 months ]
    The percent vital bone will be compared between the two treatment groups.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Contacts and Locations
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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): NCT01901783


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
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Responsible Party: Henry Greenwell, Professor, University of Louisville
ClinicalTrials.gov Identifier: NCT01901783     History of Changes
Other Study ID Numbers: 13.0331
First Posted: July 17, 2013    Key Record Dates
Last Update Posted: December 8, 2016
Last Verified: December 2016

Keywords provided by Henry Greenwell, University of Louisville:
allograft
regeneration
alveolar ridge