Antibiotic Study for Dental Implants

• Status: Completed
• Trial end date: 2009-04-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: OraPharma
• Treatments: Anti-Bacterial Agents; Antibiotics, Antitubercular; Minocycline

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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