Antibiotic Study for Dental Implants

Phase 3

Completed

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), 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)

1. one group will have the study antibiotic put on all the areas in their mouth with gum problems

2. 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

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Minocycline HCl	Minocycline HCl	1 mg microspheres of minocycline hydrochloride

Primary Outcome Measures

Name	Time	Method
Overall PD Reduction	Baseline to Day 180	Mean reduction of probing depth (PD) of qualified implant sites is derived by calculating the change of PD per qualified implant site (PD at baseline minus PD at post-baseline), and then averaging the site-specific PD changes per subject

Secondary Outcome Measures

Name	Time	Method
Initial PD Reduction	Baseline to Day 90	Mean reduction of probing depth (PD) of qualified implant sites is derived by calculating the change of PD per qualified implant site (PD at baseline minus PD at post-baseline), and then averaging the site-specific PD changes per subject
BOP Percent Reduction From Baseline	at Day 90 and Day 180	Bleeding on Probing (BOP) percentage is calculated as the number of implant sites with bleeding divided by the number of implant sites per subject times 100% at each visit; reduction of BOP percentage is the BOP percentage at baseline minus the BOP percentage post-baseline