Bio-Descaling Toothpaste for Dental Calculus Reduction
100 participantsStarted 2026-07
Plain-language summary
Dental calculus is a calcified mineralized plaque composed primarily of calcium phosphate salts covered by an unmineralized bacterial biofilm layer. It provides a substrate for bacterial colonization and soft biofilm retention, promoting the growth of pathogenic plaque, further calculus formation, gingival tissue inflammation, that could progress to periodontitis and tooth loss. Therefore, removal of dental calculus and prevention of its formation are important for maintaining periodontal health.
Professional mechanical removal remains the most effective approach to control existing dental calculus; however, it is labor-intensive and represents a burden for patients in terms of costs and access to oral health professionals. Several toothpastes have been developed to dissolve and soften mineralized deposits using abrasive and/or chemical agents. Nevertheless, highly abrasive formulations may damage tooth structures and only reduce approximately 30-50% of dental calculus, while dentifrices containing mineralization and crystallization inhibitors can prevent calculus formation but are unable to remove already formed deposits.
To address these limitations, a Bio-Descaling Powder (BDP) toothpaste has recently been introduced with the aim of removing existing dental calculus. Preliminary clinical evidence showed that the amount of calculus removed with D-Tart toothpaste was five times greater than that achieved with Colgate Total® toothpaste.
Given the high prevalence of periodontal diseases and the potential role of dental calculus in their initiation and progression, effective strategies for calculus removal and prevention are of considerable clinical interest. The use of an effective toothpaste could reduce the need for professional periodontal interventions or shorten treatment time, thereby decreasing costs and patient burden.
The aim of this study is to evaluate the efficacy of a Bio-Descaling Powder (BDP)-containing toothpaste, compared with a placebo toothpaste, in decreasing the presence of already formed dental calculus.
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 older;
. Systemically healthy, following the criteria of American Society of Anesthesiology (ASA), type I or II;
. Having at least 10 opposing teeth units with presence of at least three natural lower anterior teeth;
. Presenting at least 1.5 mm of calculus width on the lingual surface of at least one mandibular anterior teeth (Volpe-Manhold index of at least 1.5 in the lingual side of at least one of the lower anterior teeth) ;
. For patients in SPC, for at least 6 months, and the last tooth cleaning at least 3 months before, fulfilling the end point criteria of periodontal therapy \[no pockets ≥ 6 mm or \> 4 mm with bleeding on probing (BOP)\] . Localized pockets of 6 mm, without bleeding on probing, are allowed, except in the anterior-inferior sextant.
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.
. Agree to follow the study instructions, including adherence to study arm treatment, 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 may cause bias in the study. Smokers of 10 or more cigarettes per day will be excluded (Dietrich, Bernimoulin, \& Glynn, 2004);
. Antibiotics or anti-inflammatory drugs taken within 1 month prior to the study, to avoid bias when assessing the gum health;
. Currently using chlorhexidine or other antiseptic products, since these products can affect biofilm and calculus formation, therefore they can introduce bias in the assessment of calculus removal by our toothpaste;
. Sensitivity to tartar-control toothpastes;
. Unable to return for evaluations/study recalls, to avoid the significant loss in the number of participants.