Antibiotic Study for Dental Implants - Full Text View

Sponsor:	OraPharma
Information provided by (Responsible Party):	OraPharma
ClinicalTrials.gov Identifier:	NCT00662532

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 III

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

Drug Information available for: Minocycline Minocycline hydrochloride

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 February 09, 2012