Antibiotic Study for Dental Implants

Study Overview
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Brief Summary
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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
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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

Official Title
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Multi-Center Phase 3 Trial of Minocycline HCl 1mg Microspheres for the Use in Subjects With Peri-Implantitis

Conditions
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Periodontitis

Intervention / Treatment
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* Drug: Minocycline HCl


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Minocycline HCl<br>1 mg microspheres of minocycline hydrochloride | Drug: Minocycline HCl<br>* 1mg microspheres for professional subgingival administration into periodontal pockets two times throughout the duration of the trial<br>* Other names: antibiotic;|
| No Intervention: No Intervention<br>Control group receiving no drug intervention | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Baseline to Day 180 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Baseline to Day 90 | 
| 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 | at Day 90 and Day 180 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Peri-implantitis; antibiotic