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

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

Study Type: Interventional

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

Study Primary Completion Date: June 2009

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

Intervention(s) in this Clinical Trial

• Drug: Minocycline HCl
  • 1mg microspheres for professional subgingival administration into periodontal pockets two times throughout the duration of the trial

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • 1 mg microspheres of minocycline hydrochloride
• No Intervention: 2

Primary Measures

• PD reduction for all treated implant sites
  • Time Frame: Baseline to Day 180
    Safety Issue?: No

Secondary Measures

• PD reduction for all treated implant sites
  • Time Frame: Baseline to Day 90
    Safety Issue?: No
• Reduction in BOP and gain in CAL
  • Time Frame: at Day 90 and Day 180
    Safety Issue?: No
• Changes in bone level
  • Time Frame: at Day 180
    Safety Issue?: No
• Improvement in inflammatory biomarkers
  • Time Frame: at Days 30, 90 and 180
    Safety Issue?: No
• Monitor and record all nonserious Adverse Events (AEs) and Serious Adverse Events (SAEs), their frequency, severity, seriousness, and relationship to study drug
  • Time Frame: duration of study plus 30 days
    Safety Issue?: Yes

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 21 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Johnson & Johnson Consumer & Personal Products Worldwide

Overall Clinical Trial Officials and Contacts

Michael Lynch, DMD, PhD Study Director OraPharma  

Overall Contact: Joyce L Hauze, MBA, CCRA 973-385-6104 jhauze@conus.jnj.com

Information obtained from ClinicalTrials.gov on August 21, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00662532

Study ID Number: OP-P-5265-1

ClinicalTrials.gov Identifier: NCT00662532

Health Authority: United States: Food and Drug Administration