- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01431131
Ridge Preservation Comparing an Intrasocket Graft Alone to an Intrasocket Graft Plus a Facial Overlay Graft
December 6, 2016 updated by: Henry Greenwell, University of Louisville
Ridge Preservation Comparing a Socket Allograft Alone to a Socket Allograft Plus a Facial Overlay Xenograft: A Clinical and Histologic Study In Humans
The purpose of this study is to compare two methods of ridge preservation in the maxillary anterior esthetic zone to determine the best method to establish adequate bone and soft tissue to accommodate implant placement.
For the positive control group a mineralized cancellous allograft will be placed in the extraction socket.
For the test group a mineralized cancellous allograft will be placed in the extraction socket plus an additional graft will be placed to overlay the facial surface of the socket that will be composed of bovine xenograft material.
Outcomes will be clinical horizontal and vertical dimensional change and histologic analysis of the graft material at 4 months post-placement.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Subjects met the eligibility criteria if they were at least 18 years of age and had one nonmolar tooth requiring extraction that would be replaced by a dental implant.
Extraction sites were bordered by at least one tooth.
Exclusion criteria included: 1) debilitating systemic diseases, or diseases that have a clinically significant effect on the periodontium; 2) molar extraction sites; 3) presence of or history of osteonecrosis of the jaws; 4) history of IV bisphosphonate treatment; 5) history of oral bisphosphonate treatment for more than three years; 6) pregnancy or lactation; 7) known allergy to any material or medication used in the study; 8) required antibiotic prophylaxis; 9) previous head and neck radiation therapy; 10) history of chemotherapy in the last 12 months; 11) long term steroid or non-steroidal anti-inflammatory drug therapy; or 12) failure to sign an informed consent approved by the Human Studies Committee.
Patients were excluded post-treatment if they developed infection or had an adverse reaction to any of the materials used in the study.
Study Type
Interventional
Enrollment (Actual)
24
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, School of Dentistry, 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:
- 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 person that 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.
- Molar teeth.
- Presence of or history of osteonecrosis of the jaws.
- Patients who are currently taking IV bisphosphonates or who had IV treatment with bisphosphonates irrespective of the duration.
- Patients who have been treated with oral bisphosphonates for more than three years.
- Pregnant women due to the possibility of miscarriage.
- 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.
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
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: Intrasocket graft
Positive control
|
Intrasocket mineralized cancellous allograft
|
EXPERIMENTAL: Intrasocket plus facial overlay graft
Intrasocket cancellous allograft plus a facial overlay bovine xenograft
|
Intrasocket mineralized cancellous allograft plus a facial overlay graft of bovine xenograft
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Horizontal Ridge Dimension
Time Frame: Baseline and 4 months
|
WIll be measured with a digital caliper at baseline and 4 months.
|
Baseline and 4 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Histologic Healing of the Osseous Graft
Time Frame: 4 months
|
Histologic analysis to determine vital bone, nonvital bone, and trabecular space percentages
|
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, 2011
Primary Completion (ACTUAL)
July 1, 2012
Study Completion (ACTUAL)
July 1, 2012
Study Registration Dates
First Submitted
September 7, 2011
First Submitted That Met QC Criteria
September 8, 2011
First Posted (ESTIMATE)
September 9, 2011
Study Record Updates
Last Update Posted (ESTIMATE)
January 31, 2017
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
- 11.0352
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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