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| Name | Class |
|---|---|
| MedTeq | INDUSTRY |
| Mitacs | INDUSTRY |
| Visionaturolab INC. | UNKNOWN |
| Cégep Garneau |
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Periodontal disease is amongst the most prevalent oral diseases worldwide and in North America. According to the 2007/09 Canadian Health Measures Survey, 16% of Canadian adults and 24% of older adults, 60 to 79 years of age, were found to have moderate periodontal disease. Moreover, 11% of Canadian adults were found to have calculus scores in the highest range. On the other hand, recent reports on the prevalence of periodontitis in the US showed that 47.2% of adults aged 30 years and older have some form of periodontal disease and 70.1% of adults 65 years and older have periodontal disease. The estimates also showed that the expenditure for periodontal treatments in the US is about approximately $ 14.3 billion.
Since dental calculus plays an important etiological role in initiation and progression of periodontal diseases. Investigation and investment on preventive technologies to prevent the periodontal disease are important for any health care system and its end-users. Furthermore, the removal and prevention of dental calculus using an effective toothpaste could reduce the need for professional periodontal interventions or the time of these treatments that in turn reduces their cost and other burdens on patients.
The aim of this study is to assess the efficacy of D-Tart toothpaste in removing dental calculus compared to Crest® (Complete Whitening plus Scope, tartar control, Procter & Gamble, Cincinnati, OH), anti-tartar toothpaste with similar pH and texture to D- Tart toothpaste.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bio-descaling D-Tart toothpaste | Experimental | Bio-descaling D -Tart is a bio-descaler toothpaste that is manufactured at Du-Var laboratories (1460 Graham Bell, Boucherville, Québec, Canada J4B 6H5) |
|
| Crest® | Active Comparator | anti-tartar toothpaste, Complete Whitening plus Scope, tartar control produced by Procter & Gamble, Cincinnati, OH), |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bio-descaling D-Tart toothpaste | Other | Patients received Bio-descaling D-Tart toothpaste, which is a new dentifrice (Visionaturolab Inc., QC) that contains a natural bio-descaler powder of cuttlefish bone |
| Measure | Description | Time Frame |
|---|---|---|
| Change in calculus index | Calculus level in mm on teeth before and after brushing with toothpaste. | Baseline, 3 months, 9 months |
| Measure | Description | Time Frame |
|---|---|---|
| Modified Gingival Index | semi-quantitative assessment of gingival health around each tooth Absence of inflammation; Mild inflammation or with slight changes in color and texture but not in all portions of gingival marginal or papillary Mild inflammation, such as the preceding criteria, in all portions of gingival marginal or papillary Moderate, bright surface inflammation, erythema, edema and/or hypertrophy of gingival marginal or papillary Severe inflammation: erythema, edema and/or marginal gingival hypertrophy of the unit or spontaneous bleeding, papillary, congestion or ulceration |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| McGill University Faculty of Dentistry | Montreal | Quebec | H3A 1G1 | Canada |
The research team will collect the personal information of participants. This may include their name, address, phone number, health plan number, date of birth, dental and medical history, and medical-related information, which shall be collected from all participants by asking them to fill dental and medical history forms. All information collected from participants will be kept Confidential at the study site and secure in a locked file cabinet in Cégep Garneau. The electronically stored information would be also secured in a computer hard drive accessible only to researchers with a confidential access code. This information will be kept for 5 years after the study is terminated. All study data will also be sent to the sponsor and/or its representatives, as long as they agree to use the information as described previously. However, this data will not identify the participants by name.
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| ID | Term |
|---|---|
| D003728 | Dental Calculus |
| D010510 | Periodontal Diseases |
| D002137 | Calculi |
| D003773 | Dental Plaque |
| ID | Term |
|---|---|
| D003741 | Dental Deposits |
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
| D020763 | Pathological Conditions, Anatomical |
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| Crest® toothpaste | Other | Patients received Crest toothpaste; Anti-tartar toothpaste |
|
| Baseline, 3 months, 9 months |
| Shaw and Murray Stain Index | Quantitative assessment of extrinsic stains on the labial and palatal/lingual surfaces of the upper and lower central and lateral incisors; The outline of the labial and lingual surfaces of all eight incisor teeth are enlarged to scale (magnification X 4) and each tooth face divided into 4-mm squares. All areas of extrinsic stain are drawn by the examiner on a grid system and then measured. | baseline, 3 months, 9 months |
| Quigley-Hain plaque index (QHI) | semi-quantitative assessment of plaque around each tooth; Score 0: No plaque Score 1: Isolated flecks of plaque at the gingival margin Score 2: A continuous band of plaque up to 1mm at the gingival margin Score 3: Plaque greater than 1mm in width and covering up to one third of the tooth surface Score 4: Plaque covering from one thirds to two thirds of the tooth surface Score 5: Plaque covering more than two thirds of the tooth surface | baseline, 3 months, 9 months |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009059 | Mouth Diseases |