Status:
COMPLETED
Development of a New Toothpaste for the Removal of Dental Calculus.
Lead Sponsor:
Faleh Tamimi
Collaborating Sponsors:
MedTeq
Mitacs
Conditions:
Calculus, Dental
Periodontal Diseases
Eligibility:
All Genders
18+ years
Phase:
NA
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 30 2020
Estimated Enrollment :
87 Patients enrolled
Trial Details
Trial ID
NCT04381403
Start Date
February 1 2017
End Date
April 30 2020
Last Update
July 17 2020
Active Locations (1)
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1
McGill University Faculty of Dentistry
Montreal, Quebec, Canada, H3A 1G1