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Antibiotic Study for Dental Implants

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
OraPharma
ClinicalTrials.gov Identifier:
NCT00662532
First received: April 17, 2008
Last updated: December 6, 2011
Last verified: December 2011
History of Changes
  Purpose

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


Condition Intervention Phase
Periodontitis
 Drug: Minocycline HCl
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Multi-Center Phase 3 Trial of Minocycline HCl 1mg Microspheres for the Use in Subjects With Peri-Implantitis

Resource links provided by NLM:

MedlinePlus related topics: Antibiotics
U.S. FDA Resources

Further study details as provided by OraPharma:

Primary Outcome Measures:
  • Overall PD Reduction [ Time Frame: Baseline to Day 180 ] [ Designated as safety issue: No ]
    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:
  • Initial PD Reduction [ Time Frame: Baseline to Day 90 ] [ Designated as safety issue: No ]
    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 [ Time Frame: at Day 90 and Day 180 ] [ Designated as safety issue: No ]
    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


Enrollment: 44
Study Start Date: April 2008
Study Completion Date: April 2009
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: antibiotic
No Intervention: No Intervention
Control group receiving no drug intervention

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
  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00662532

Locations
United States, Colorado
JJCPPW Investigational Site
Aurora, Colorado, United States, 80012
United States, Michigan
JJCPPW Investigational Site
Ann Arbor, Michigan, United States, 48106
United States, New Jersey
JJCPPW Investigational Site
Hazlet, New Jersey, United States, 07730
United States, Washington
JJCPPW Investigational Site
Seattle, Washington, United States, 98195
Sponsors and Collaborators
OraPharma
Investigators
Study Director: Michael Lynch, DMD, PhD OraPharma
  More Information

No publications provided

Responsible Party: OraPharma
ClinicalTrials.gov Identifier: NCT00662532     History of Changes
Other Study ID Numbers: OP-P-5265-1
Study First Received: April 17, 2008
Results First Received: April 27, 2010
Last Updated: December 6, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by OraPharma:
Peri-implantitis; antibiotic

Additional relevant MeSH terms:
Periodontitis
Peri-Implantitis
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
 Anti-Bacterial Agents
Minocycline
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on June 18, 2013