Antibiotic Study for Dental Implants

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), the dentist will:

• do a special cleaning of the implants
• examine the whole mouth
• collect some fluid
• take x-rays
• put the people into one of two groups (taking into account whether or not they smoke)

• one group will have the study antibiotic put on all the areas in their mouth with gum problems
• the other group will not receive the antibiotic At Visit 3 (about a month later), only fluid samples will be collected.

At Visit 4 (about 3 months later), the dentist will:

• collect fluid samples
• examine the whole mouth
• apply the antibiotic again for people in that group

At Visit 5 (about 6 months later), the dentist will:

• collect fluid samples
• examine the whole mouth
• take x-rays

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