Status:
COMPLETED
Efficacy of Socket Grafting for Alveolar Ridge Preservation
Lead Sponsor:
University of Iowa
Collaborating Sponsors:
Osteogenics Biomedical
Conditions:
Atrophy of Edentulous Alveolar Ridge
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
The purpose of this study is to clinically and radiographically assess whether the use of a ridge preservation technique significantly minimizes alveolar ridge resorption following tooth extraction.
Detailed Description
Subjects requiring single-rooted tooth extractions and future tooth replacement therapy with implant-supported restorations will be recruited. Subjects will be randomly assigned to either a control (t...
Eligibility Criteria
Inclusion
- Age: 18 to 75 years.
- Gender: No restriction.
- Subjects must require a single-rooted tooth extraction (Tooth deemed as periodontally and/or restoratively hopeless), except lower incisors and second premolars.
- Subjects must be able and willing to follow instructions related to the study procedures.
- Subjects must have read, understood and signed an informed consent form.
Exclusion
- Reported allergy or hypersensitivity to any of the products to be used in the study.
- Severe hematologic disorders, such as hemophilia or leukemia.
- Active severe infectious diseases that may compromise normal healing.
- Liver or kidney dysfunction/failure.
- Currently under cancer treatment or within 18 months from completion of radio- or chemotherapy.
- Subjects who have a long-term history of oral bisphosphonate use (i.e. 10 years or more).
- Subjects with a history of IV bisphosphonates.
- Subjects with uncontrolled diabetes.
- Subjects with severe metabolic bone diseases, such as Paget's disease of bone, will be excluded.
- Pregnant women or nursing mothers.
- Smokers: Subjects who have smoked within 6 months of study onset.
- Concomitant medications: Subjects on concomitant drug therapy for systemic conditions that may affect the outcomes of the study will not be included in the study.
- NOTE: Occasional, short-term use (7-14 days) of analgesics or common cold medications is permitted. Use of such medications will be reviewed and recorded by the investigator.
- \- Any other non-specified reason that from the point of views of the investigators will make a candidate not a suitable subject for the study (e.g. limited mouth opening).
Key Trial Info
Start Date :
March 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2014
Estimated Enrollment :
59 Patients enrolled
Trial Details
Trial ID
NCT01794806
Start Date
March 1 2013
End Date
October 1 2014
Last Update
August 17 2017
Active Locations (1)
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1
University of Iowa College of Dentistry - Craniofacial Clinical Research Center
Iowa City, Iowa, United States, 52242