Phase 3
N=44
Antibiotic Study for Dental Implants
Periodontitis
Bottom Line
View on ClinicalTrials.gov: NCT00662532 ↗Enrolled (actual)
44
Serious AEs
9.1%
Results posted
May 2010
Primary outcome: Primary: Overall PD Reduction — 1.25; 0.66 mm
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Minocycline HCl (Drug)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- All
- Sponsor
- OraPharma
- Primary completion
- Apr 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overall PD Reduction |
1.25; 0.66 | — |
| SECONDARY Initial PD Reduction |
1.02; 0.49 | — |
| SECONDARY BOP Percent Reduction From Baseline |
42.17; 22.53; 60.75; 32.86 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT00662532). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.