McGill University Faculty of Dentistry
Montreal, Quebec, H3A 1G1, Canada
NCT Number: NCT04381403
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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Notify Me18 year and older
All sexes
Interventional
Not applicable
Montreal, Quebec, H3A 1G1, Canada
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
Patients received Crest toothpaste; Anti-tartar toothpaste
Time frame: Baseline, 3 months, 9 months
Calculus level in mm on teeth before and after brushing with toothpaste.
Time frame: Baseline, 3 months, 9 months
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
Time frame: baseline, 3 months, 9 months
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.
Time frame: baseline, 3 months, 9 months
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
Faleh Tamimi
Other
Development of Toothpaste for the Removal of Dental Calculus: a Double-blind, Randomized Controlled Trial.
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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