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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.
At Visit 1, the dentist will:
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)
At Visit 4 (about 3 months later), the dentist will:
At Visit 5 (about 6 months later), the dentist will:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Minocycline HCl | Experimental | 1 mg microspheres of minocycline hydrochloride |
|
| No Intervention | No Intervention | Control group receiving no drug intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Minocycline HCl | Drug | 1mg microspheres for professional subgingival administration into periodontal pockets two times throughout the duration of the trial |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael Lynch, DMD, PhD | OraPharma | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| JJCPPW Investigational Site | Aurora | Colorado | 80012 | United States | ||
| JJCPPW Investigational Site |
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| ID | Title | Description |
|---|---|---|
| FG000 | Minocycline HCl | 1 mg microspheres of minocycline hydrochloride |
| FG001 | No Intervention | Control group receiving no drug intervention |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Minocycline HCl | 1 mg microspheres of minocycline hydrochloride |
| BG001 | No Intervention | Control group receiving no drug intervention |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | Posted | Mean | Standard Deviation | mm | Baseline to Day 180 |
|
180 Days
Adverse Events were a primary outcome measure, so we have used a 1% reporting threshold, rather than the standard 5%
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Minocycline HCl | 1 mg microspheres of minocycline hydrochloride |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Volvulus | Gastrointestinal disorders | MedDRA (12.0) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Tooth Abscess | Infections and infestations | MedDRA (12.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ms. Bindu Patel, Senior Scientist, Regulatory Affairs and Quality Assurance | OraPharma | 215-420-4064 | bpatel@orapharma.com |
| ID | Term |
|---|---|
| D010518 | Periodontitis |
| D057873 | Peri-Implantitis |
| ID | Term |
|---|---|
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
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| ID | Term |
|---|---|
| D008911 | Minocycline |
| D000900 | Anti-Bacterial Agents |
| ID | Term |
|---|---|
| D013754 | Tetracyclines |
| D009279 | Naphthacenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
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|
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 |
| Ann Arbor |
| Michigan |
| 48106 |
| United States |
| JJCPPW Investigational Site | Hazlet | New Jersey | 07730 | United States |
| JJCPPW Investigational Site | Seattle | Washington | 98195 | United States |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
| Secondary | 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 | Posted | Mean | Standard Deviation | mm | Baseline to Day 90 |
|
|
|
| Secondary | 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 | ITT | Posted | Least Squares Mean | Standard Deviation | Percentage of Participants | at Day 90 and Day 180 |
|
|
|
| 1 |
| 22 |
| 6 |
| 22 |
| EG001 | No Intervention | Control group receiving no drug intervention | 3 | 22 | 4 | 22 |
| Death | General disorders | MedDRA (12.0) | Systematic Assessment |
|
| Lung Neoplasm Malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (12.0) | Systematic Assessment |
|
| Hysterectomy | Surgical and medical procedures | MedDRA (12.0) | Systematic Assessment |
|
| Ear Infection | Infections and infestations | MedDRA (12.0) | Systematic Assessment |
|
| Infection | Infections and infestations | MedDRA (12.0) | Systematic Assessment |
|
| Onychomycosis | Infections and infestations | MedDRA (12.0) | Systematic Assessment |
|
| Upper Respiratory Tract Infection | Infections and infestations | MedDRA (12.0) | Systematic Assessment |
|
| Gastrooesophageal Reflux Disease | Gastrointestinal disorders | MedDRA (12.0) | Systematic Assessment |
|
| Bite | Injury, poisoning and procedural complications | MedDRA (12.0) | Systematic Assessment |
|
| Tooth Fracture | Injury, poisoning and procedural complications | MedDRA (12.0) | Systematic Assessment |
|
| Endodontic Procedure | Surgical and medical procedures | MedDRA (12.0) | Systematic Assessment |
|
| Tooth Extraction | Surgical and medical procedures | MedDRA (12.0) | Systematic Assessment |
|
| Nodule | General disorders | MedDRA (12.0) | Systematic Assessment |
|
| Vertigo | Ear and labyrinth disorders | MedDRA (12.0) | Systematic Assessment |
|
| Seasonal Allergy | Immune system disorders | MedDRA (12.0) | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (12.0) | Systematic Assessment |
|
| Joint Swelling | Musculoskeletal and connective tissue disorders | MedDRA (12.0) | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA (12.0) | Systematic Assessment |
|
| Lichen Planus | Skin and subcutaneous tissue disorders | MedDRA (12.0) | Systematic Assessment |
|
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| D006844 |
| Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
| D000890 | Anti-Infective Agents |
| D045506 | Therapeutic Uses |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |