- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01901783
Ridge Augmentation Without Primary Closure
December 6, 2016 updated by: Henry Greenwell, University of Louisville
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
A maximum of 30 patients will be selected that meet the following criteria:
Inclusion Criteria
- 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.
- Healthy person that is at least 18 years old.
- Patient understands and signs an informed consent approved by the University of Louisville Human Studies Committee.
Exclusion Criteria
- Patients with debilitating systemic diseases, diseases that affect the periodontium, or psychological problems that would interfere with treatment.
- Previous head and neck radiation or chemotherapy within the previous 12 months.
- Patients with known allergy to any of the materials that will be used in the study.
- Smokers.
- Patients who need prophylactic antibiotics prior to dental procedures.
- Patients on long-term steroid therapy or oral bisphosphonates > 3 years or any IV biosphosphonates.
- Patients who are pregnant.
Study Type
Interventional
Enrollment (Actual)
18
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Kentucky
-
Louisville, Kentucky, United States, 40202
- Graduate Periodontics Clinic University of Louisville
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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.
- Healthy person that is at least 18 years old.
- Patient understands and signs an informed consent approved by the University of Louisville Human Studies Committee.
Exclusion Criteria:
- Patients with debilitating systemic diseases, diseases that affect the periodontium, or psychological problems that would interfere with treatment.
- Previous head and neck radiation or chemotherapy within the previous 12 months.
- Patients with known allergy to any of the materials that will be used in the study.
- Smokers.
- Patients who need prophylactic antibiotics prior to dental procedures.
- Patients on long-term steroid therapy or oral bisphosphonates > 3 years or any IV biosphosphonates.
- Patients who are pregnant.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / 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.
|
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 Names:
|
Experimental: Without primary closure
The ridge augmentation graft will be covered with a barrier membrane and the soft tissue will not be primarily closed.
|
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 Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Crestal ridge width
Time Frame: 4 months
|
The ridge width at the crest will be compared between the two treatment groups.
|
4 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percent vital bone
Time Frame: 4 months
|
The percent vital bone will be compared between the two treatment groups.
|
4 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2013
Primary Completion (Actual)
June 1, 2014
Study Completion (Actual)
June 1, 2014
Study Registration Dates
First Submitted
July 12, 2013
First Submitted That Met QC Criteria
July 16, 2013
First Posted (Estimate)
July 17, 2013
Study Record Updates
Last Update Posted (Estimate)
December 8, 2016
Last Update Submitted That Met QC Criteria
December 6, 2016
Last Verified
December 1, 2016
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 13.0331
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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