Antibiotic Study for Dental Implants

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 Overview

• Status: Completed
• Conditions: Periodontitis
• Intervention / Treatment: Drug: Minocycline HCl

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

• Study Type: Interventional
• Enrollment (Actual): 44
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Aurora, Colorado, United States, 80012
      • JJCPPW Investigational Site
  • Michigan
    • Ann Arbor, Michigan, United States, 48106
      • JJCPPW Investigational Site
  • New Jersey
    • Hazlet, New Jersey, United States, 07730
      • JJCPPW Investigational Site
  • Washington
    • Seattle, Washington, United States, 98195
      • JJCPPW Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Minocycline HCl; 1 mg microspheres of minocycline hydrochloride	Drug: Minocycline HCl; 1mg microspheres for professional subgingival administration into periodontal pockets two times throughout the duration of the trial; Other Names: antibiotic
NO_INTERVENTION: No Intervention; Control group receiving no drug intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall PD Reduction	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	Baseline to Day 180

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Initial PD Reduction	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	Baseline to Day 90
BOP Percent Reduction From Baseline	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	at Day 90 and Day 180

Collaborators and Investigators

• Sponsor: OraPharma
• Investigators: Study Director: Michael Lynch, DMD, PhD, OraPharma

Study record dates

Study Major Dates

• Study Start: April 1, 2008
• Primary Completion (ACTUAL): April 1, 2009
• Study Completion (ACTUAL): April 1, 2009

Study Registration Dates

• First Submitted: April 17, 2008
• First Submitted That Met QC Criteria: April 17, 2008
• First Posted (ESTIMATE): April 21, 2008

Study Record Updates

• Last Update Posted (ESTIMATE): December 12, 2011
• Last Update Submitted That Met QC Criteria: December 6, 2011
• Last Verified: December 1, 2011

More Information

Terms related to this study

• Keywords: Peri-implantitis; antibiotic
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Periodontitis; Peri-Implantitis; Anti-Infective Agents; Anti-Bacterial Agents; Minocycline
• Other Study ID Numbers: OP-P-5265-1