Development of a New Toothpaste for the Removal of Dental Calculus. (NCT04381403) | Clinical Trial Compass
CompletedNot Applicable
Development of a New Toothpaste for the Removal of Dental Calculus.
Canada87 participantsStarted 2017-02-01
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 compromi…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.