Back to resultsAntibiotic Study for Dental Implants
Primary Purpose
Periodontitis
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Minocycline HCl
Sponsored by
About this trial
This is an interventional treatment trial for Periodontitis focused on measuring Peri-implantitis; antibiotic
Eligibility 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
Sites / Locations
- JJCPPW Investigational Site
- JJCPPW Investigational Site
- JJCPPW Investigational Site
- JJCPPW Investigational Site
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Minocycline HCl
No Intervention
Arm Description
1 mg microspheres of minocycline hydrochloride
Control group receiving no drug intervention
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00662532
Brief Title
Antibiotic Study for Dental Implants
Official Title
Multi-Center Phase 3 Trial of Minocycline HCl 1mg Microspheres for the Use in Subjects With Peri-Implantitis
Study Type
Interventional
2. Study Status
Record Verification Date
December 2011
Overall Recruitment Status
Completed
Study Start Date
April 2008 (undefined)
Primary Completion Date
April 2009 (Actual)
Study Completion Date
April 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
OraPharma
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study is for people at least 21 years old who have signs of problems, like swollen gums and shrinking bones, by dental implants.
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)
one group will have the study antibiotic put on all the areas in their mouth with gum problems
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Periodontitis
Keywords
Peri-implantitis; antibiotic
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
44 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Minocycline HCl
Arm Type
Experimental
Arm Description
1 mg microspheres of minocycline hydrochloride
Arm Title
No Intervention
Arm Type
No Intervention
Arm Description
Control group receiving no drug intervention
Intervention Type
Drug
Intervention Name(s)
Minocycline HCl
Other Intervention Name(s)
antibiotic
Intervention Description
1mg microspheres for professional subgingival administration into periodontal pockets two times throughout the duration of the trial
Primary Outcome Measure Information:
Title
Overall PD Reduction
Description
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
Time Frame
Baseline to Day 180
Secondary Outcome Measure Information:
Title
Initial PD Reduction
Description
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
Time Frame
Baseline to Day 90
Title
BOP Percent Reduction From Baseline
Description
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
Time Frame
at Day 90 and Day 180
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Lynch, DMD, PhD
Organizational Affiliation
OraPharma
Official's Role
Study Director
Facility Information:
Facility Name
JJCPPW Investigational Site
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80012
Country
United States
Facility Name
JJCPPW Investigational Site
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48106
Country
United States
Facility Name
JJCPPW Investigational Site
City
Hazlet
State/Province
New Jersey
ZIP/Postal Code
07730
Country
United States
Facility Name
JJCPPW Investigational Site
City
Seattle
State/Province
Washington
ZIP/Postal Code
98195
Country
United States
12. IPD Sharing Statement
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Antibiotic Study for Dental Implants
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