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Periodontal disease (commonly called gum disease) is generally treated by deep cleaning of the root surfaces of the teeth. This is also called scaling and root planing. Placing a topical antibiotic into the periodontal pocket at the time of scaling and root planing may help reduce pocket depth and thus help the periodontal disease. Periocline (minocycline HCl) 2.1% gel is a topical antibiotic approved in a number of countries for this use, and is now being tested in the US.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Scaling and root planing + SHAM TX | Sham Comparator | sham treatment |
|
| Scaling and root planing + Vehicle | Placebo Comparator | Placebo |
|
| Scaling & root planing + Periocline Gel | Active Comparator | Minocycline HCL 2.1% |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| minocycline HCl 2.1% | Drug | Minocycline HCl 2.1% gel as an adjunct to scaling and root planing. Dosing is by topical delivery into gingival pockets at baseline, 2 weeks, 4 weeks, 3 months and 6 months. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Pocket Depth. | Average change of Pocket Depth at 9 months from baseline | baseline & 9 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Robert Genco, DDS, PhD | State University of New York at Buffalo | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35294 | United States | ||
| University of California - San Francisco |
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| ID | Title | Description |
|---|---|---|
| FG000 | Scaling and Root Planing + SHAM TX | Empty syringe + Scaling and root planing |
| FG001 | Scaling & Root Planing + Periocline Gel | Gel WITH Minocycline HCL 2.1% + Scaling & root planing minocycline HCl 2.1% : Minocycline HCl 2.1% gel as an adjunct to scaling and root planing. Dosing is by topical delivery into gingival pockets at baseline, 2 weeks, 4 weeks, 3 months and 6 months. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Scaling and root planing | Procedure | scaling and root planing |
|
|
| San Francisco |
| California |
| 94143 |
| United States |
| University of Florida | Gainsville | Florida | 32610 | United States |
| University of Maryland - Dental School | Baltimore | Maryland | 21201 | United States |
| Boston University Dental School | Boston | Massachusetts | 02118 | United States |
| University of Michigan Oral Health Research Center | Ann Arbor | Michigan | 48106 | United States |
| University of Minnesota | Minneapolis | Minnesota | 55455 | United States |
| State University of New York at Buffalo, Dental Medicine | Buffalo | New York | 14214 | United States |
| University of Pennsylvania Dental School | Philadelphia | Pennsylvania | 19104 | United States |
| University of Texas Health Science Center at San Antonio | San Antonio | Texas | 78229 | United States |
| FG002 | Scaling and Root Planing + Vehicle | Gel WITHOUT 2.1% Minocycline HCl + Scaling and root planing |
| COMPLETED |
|
| NOT COMPLETED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Scaling and Root Planing + SHAM TX | sham treatment Scaling and root planing : scaling and root planing |
| BG001 | Scaling & Root Planing + Periocline Gel | Minocycline HCL 2.1% minocycline HCl 2.1% : Minocycline HCl 2.1% gel as an adjunct to scaling and root planing. Dosing is by topical delivery into gingival pockets at baseline, 2 weeks, 4 weeks, 3 months and 6 months. |
| BG002 | Scaling and Root Planing + Vehicle | Placebo Scaling and root planing : scaling and root planing |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
|
| 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 | Change in Pocket Depth. | Average change of Pocket Depth at 9 months from baseline | Intent to treat | Posted | Least Squares Mean | 95% Confidence Interval | mm | baseline & 9 months |
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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 | Scaling and Root Planing + SHAM TX | sham treatment Scaling and root planing : scaling and root planing | 8 | 200 | 173 | 200 | ||
| EG001 | Scaling & Root Planing + Periocline Gel | Minocycline HCL 2.1% minocycline HCl 2.1% : Minocycline HCl 2.1% gel as an adjunct to scaling and root planing. Dosing is by topical delivery into gingival pockets at baseline, 2 weeks, 4 weeks, 3 months and 6 months. | 5 | 202 | 189 | 202 | ||
| EG002 | Scaling and Root Planing + Vehicle | Placebo Scaling and root planing : scaling and root planing | 3 | 200 | 182 | 200 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Rib Fracture | Injury, poisoning and procedural complications | Subject was involved in a motorcycle accident on 30 April 2006 and was hospitalized. |
| ||
| Abdominal hernia | Gastrointestinal disorders |
| |||
| Tooth injury | Injury, poisoning and procedural complications |
| |||
| Cyst | Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
| |||
| Death | Social circumstances | Died in a car accident |
| ||
| Brain neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
| |||
| Cellulitis and pulmonary embolism | Cardiac disorders |
| |||
| Hysterectomy | Reproductive system and breast disorders |
| |||
| Myocardial infarction and fatigue | Cardiac disorders |
| |||
| Right knee replacement surgery | Musculoskeletal and connective tissue disorders |
| |||
| Transient ischemic attack | Cardiac disorders |
| |||
| Chest pain | Social circumstances |
| |||
| Cellulitis of male organ external epididymitis | Reproductive system and breast disorders |
| |||
| Hopsitalization for complications from Multiple Sclerosis | Musculoskeletal and connective tissue disorders |
| |||
| Pain and injury | Surgical and medical procedures |
| |||
| Cast | Social circumstances | Subject slipped on the ice in driveway. An x-ray showed a fracture of the left ankle. A cast was placed and subsequently replaced with a brace enabling the subject to walk without assistive devices. |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Gastrointestinal disorders | Gastrointestinal disorders | Collected in a non-specific manner |
| ||
| Injury, poisoning and procedural complications | Injury, poisoning and procedural complications | Collected in a non-specific manner |
| ||
| Gerenal Disorders and adminstration site conditions | General disorders | Collected in a non-specific manner |
| ||
| Infections and infestations | Infections and infestations | Collected in a non-specific manner |
| ||
| Nervous system disorders | Nervous system disorders | Collected in a non-specific manner |
| ||
| Musculoskeletal and connective tissue disorders | Musculoskeletal and connective tissue disorders | Collected in a non-specific manner |
| ||
| Respiratory, thoracic, and mediastinal disorders | Respiratory, thoracic and mediastinal disorders | Collected in a non-specific manner |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Marie Wilson, Clinical Program Manager | Sunstar Americas, Inc | 773-481-3327 | marie.wilson@us.sunstar.com |
| ID | Term |
|---|---|
| D055113 | Chronic Periodontitis |
| ID | Term |
|---|---|
| D010518 | Periodontitis |
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D014080 | Tooth Exfoliation |
| D016745 | Root Planing |
| ID | Term |
|---|---|
| D009063 | Dental Physiological Phenomena |
| D055688 | Digestive System and Oral Physiological Phenomena |
| D012534 | Dental Scaling |
| D003777 | Dental Prophylaxis |
| D010517 | Periodontics |
| D003813 | Dentistry |
| D013357 | Subgingival Curettage |
| D011313 | Preventive Dentistry |
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| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|