Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
44 participants
INTERVENTIONAL
2008-04-30
2009-04-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
* 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
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Minocycline HCl
1 mg microspheres of minocycline hydrochloride
Minocycline HCl
1mg microspheres for professional subgingival administration into periodontal pockets two times throughout the duration of the trial
No Intervention
Control group receiving no drug intervention
No interventions assigned to this group
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Minocycline HCl
1mg microspheres for professional subgingival administration into periodontal pockets two times throughout the duration of the trial
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
21 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
OraPharma
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Michael Lynch, DMD, PhD
Role: STUDY_DIRECTOR
OraPharma
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
JJCPPW Investigational Site
Aurora, Colorado, United States
JJCPPW Investigational Site
Ann Arbor, Michigan, United States
JJCPPW Investigational Site
Hazlet, New Jersey, United States
JJCPPW Investigational Site
Seattle, Washington, United States
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
OP-P-5265-1
Identifier Type: -
Identifier Source: org_study_id