Antibiotic Study for Dental Implants

OraPharma

Status and phase

Completed

Phase 3

Conditions

Periodontitis

Treatments

Drug: Minocycline HCl

Study type

Interventional

Funder types

Industry

Identifiers

OP-P-5265-1

Details and patient eligibility

About

This study is for people at least 21 years old who have signs of problems, like swollen gums and shrinking bones, by dental implants.

Full description

At Visit 1, the dentist will:

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:

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

Enrollment

44 patients

Sex

All

Ages

21+ years old

Volunteers

No Healthy Volunteers

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