Status:
COMPLETED
Antibiotic Study for Dental Implants
Lead Sponsor:
OraPharma
Conditions:
Periodontitis
Eligibility:
All Genders
21+ years
Phase:
PHASE3
Brief Summary
This study is for people at least 21 years old who have signs of problems, like swollen gums and shrinking bones, by dental implants.
Detailed Description
At Visit 1, the dentist will: * do an oral exam * ask some questions * decide if the person qualifies for being in the study * make an appointment for Visit 2 if they qualify At Visit 2 (Baseline), ...
Eligibility Criteria
Inclusion
- 21 years of age and good general health
- appropriately documented Informed Consent
- willing to adhere to the study schedule, prohibitions and restrictions specified in the protocol
- female subjects must meet the pregnancy and contraceptive requirements
- must have oral health appropriate for study inclusion
Exclusion
- oral health inappropriate for study inclusion
- females self-reporting pregnancy or lactation, or having a positive urine pregnancy result
- reporting any of the following conditions:
- allergy to a tetracycline-class drug
- systemic medical conditions requiring antibiotic prophylaxis prior to invasive dental procedures
- active systemic infectious disease such as hepatitis, human immunodeficiency virus (HIV) or tuberculosis
- diagnosed with clinically significant or unstable organic disease, or compromised healing potential, heart murmurs, histories of rheumatic fever, valvular disease or prosthetic joint replacement
- participation in a dental clinical trial or use of an investigational drug within 30 days of enrollment
- employees of the Investigator or study center, with direct involvement in the proposed study or other studies, as well as family members of the employees or the Investigator
- anyone who the investigator determines should not be included in the study for any reason that could compromise safety or the analysis of study results
Key Trial Info
Start Date :
April 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2009
Estimated Enrollment :
44 Patients enrolled
Trial Details
Trial ID
NCT00662532
Start Date
April 1 2008
End Date
April 1 2009
Last Update
December 12 2011
Active Locations (4)
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1
JJCPPW Investigational Site
Aurora, Colorado, United States, 80012
2
JJCPPW Investigational Site
Ann Arbor, Michigan, United States, 48106
3
JJCPPW Investigational Site
Hazlet, New Jersey, United States, 07730
4
JJCPPW Investigational Site
Seattle, Washington, United States, 98195