Antibiotic Study for Dental Implants

Condition(s) targeted: Periodontitis

Intervention: Minocycline HCl (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: Johnson & Johnson Consumer & Personal Products Worldwide

Official(s) and/or principal investigator(s):
Michael Lynch, DMD, PhD, Study Director, Affiliation: OraPharma

Overall contact:
Joyce L Hauze, MBA, CCRA, Phone: 973-385-6104, Email: jhauze@its.jnj.com

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

Official title: Multi-Center Phase 3 Trial of Minocycline HCl 1mg Microspheres for the Use in Subjects With Peri-Implantitis

Study design: Treatment, Randomized, Double Blind (Subject, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study

Primary outcome: PD reduction for all treated implant sites

Secondary outcome:

PD reduction for all treated implant sites

Reduction in BOP and gain in CAL

Changes in bone level

Improvement in inflammatory biomarkers

Monitor and record all nonserious Adverse Events (AEs) and Serious Adverse Events (SAEs), their frequency, severity, seriousness, and relationship to study drug

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

Minimum age: 21 Years. Maximum age: N/A. Gender(s): Both.

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

Joyce L Hauze, MBA, CCRA, Phone: 973-385-6104, Email: jhauze@its.jnj.com

A J&J CPPW Investigational Site, Frankfurt am Main 60590, Germany; Active, not recruiting

A J&J CPPW Investigational Site, Münster 48147, Germany; Active, not recruiting

A J&J CPPW Investigational Site, Bonn 53111, Germany; Active, not recruiting

A J&J CPPW Investigational Site, Düsseldorf 40225, Germany; Active, not recruiting

A J&J CPPW Investigational Site, Olsberg 59939, Germany; Active, not recruiting

A J&J CPPW Investigational Site, Brescia 25123, Italy; Active, not recruiting

A J&J CPPW Investigational Site, Siena 53100, Italy; Active, not recruiting

JJCPPW Investigational Site, Aurora, Colorado 80012, United States; Recruiting
Pam McClain, Principal Investigator

A J&JCPPW Investigational Site, Lido di Camaiore, LU 55041, Italy; Active, not recruiting

JJCPPW Investigational Site, Ann Arbor, Michigan 48106, United States; Recruiting
William V Giannobile, Dr., Principal Investigator

JJCPPW Investigational Site, Hazlet, New Jersey 07730, United States; Recruiting
Wayne Aldredge, Dr., Principal Investigator

JJCPPW Investigational Site, Seattle, Washington 98195, United States; Recruiting
Thomas Flemmig, Principal Investigator

Starting date: April 2008
Ending date: September 2009
Last updated: September 24, 2008