Clinical trial NCT04381403: Development of a New Toothpaste for the Removal of Dental Calculus.
Official title: Development of Toothpaste for the Removal of Dental Calculus: a Double-blind, Randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Calculus, Dental
Periodontal Diseases
Periodontal Inflammation
Keywords: Oral Hygiene
Calculus
Dental plaque
Lead sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre
Sponsor class: OTHER
Collaborators: name: MedTeq
name: Mitacs
name: Visionaturolab INC.
name: Cégep Garneau
First posted: 2020-05-08
Enrollment: 87
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* Aged 18 years and over, to ensure compliance with the study instructions
* Systemically healthy to exclude the possibility of calculus formation due to disease;
* Has at least 20 sound natural teeth including all lower anterior teeth, the main location of calculus build up;
* Having the history of previous calculus formation (at least 1.5 mm of calculus width) on the lingual surfaces of the mandibular anterior teeth after 3- 6 months of receiving a professional prophylaxis treatment, for better assessment of the toothpaste effectiveness;
* Agree to follow the study instruction: adherence to study arm, for the study timeline.

Exclusion Criteria:

* Pregnancy: pregnant women at high risk of developing gum inflammation that usually occurs during pregnancy, which could introduce bias to the study;
* any physical handicap, psychological or health conditions that might jeopardize the ability of the patient to brush his/ her teeth, these complications cause bias in the study;
* Antibiotics or anti-inflammatory drugs are taken within 1 month prior to the study, to avoid bias when assessing the gum health;
* Currently using Chlorhexidine oral products, since these products can affect biofilm and calculus formation, therefore they can introduce bias in our assessment of calculus removal by our toothpaste;
* Sensitivity to tartar-control toothpaste;
* Patients currently receiving dental treatment that would result in the removal of plaque or calculus and compromise our ability to measure calculus removed by the toothpaste;
* unable to return for evaluations/study recalls, to avoid the significant loss in the number of participants; 9) Having the diagnosis of Periodontal Screening and Recording scale (PSR) of 4, these type of patients have advanced periodontitis with a high risk of tooth loss (periodontal pockets of 6 mm and more) and could bias the treatment outcomes.

Primary outcomes:
measure: Change in calculus index
timeFrame: Baseline, 3 months, 9 months
Secondary outcomes:
measure: Modified Gingival Index
timeFrame: Baseline, 3 months, 9 months
measure: Shaw and Murray Stain Index
timeFrame: baseline, 3 months, 9 months
measure: Quigley-Hain plaque index (QHI)
timeFrame: baseline, 3 months, 9 months
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: McGill University Faculty of Dentistry
state: Quebec
Study officials:
References: