Bio-Descaling Toothpaste for Dental Calculus Reduction

Official title

Efficacy of a Novel Toothpaste Containing a Bio-Descaling Powder (BDP) in Reducing Dental Calculus: A Double Blind Randomized Controlled Clinical Trial

Overview

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.

Detailed description

Dental calculus is a calcified mineralized plaque, composed primarily of calcium phosphate salts covered by an unmineralized bacterial biofilm layer. It is firmly attached to the tooth, fills the pits and irregularities of tooth surfaces and attaches to the exposed dental roots). It offers a substrate for bacteria colonization, soft biofilm retention and subsequently the growth of pathogenic plaque. This leads to further calculus formation and gingival tissue inflammation that could progress to periodontitis and tooth loss. Removal of dental calculus, and prevention of calculus formation, are, therefore, important to maintain adequate periodontal health.

The most effective approach to control already present dental calculus is to remove it professionally, by mechanical means, by dentists and dental hygienists at the dental clinic. This labor-intensive procedure poses a burden to patients in terms of costs and access to oral health professionals. Therefore, there has been substantial interest in the development and implementation of approaches that will reduce this burden. In this regard, newly introduced toothpastes have been designed aiming to dissolve and soften the mineralized deposits, using abrasive and/or chemical agents. However, toothpastes enriched with strong abrasives could damage the tooth structures, and are only able to reduce approximately 30-50% of dental calculus, while dentifrices containing mineralization and crystallization inhibitors can only prevent the calculus formation, and not remove calculus already formed.

To the best of our knowledge, there is no toothpaste that efficiently removes existing calculus deposits from teeth. Therefore, recently a new product has been introduced to overcome the limitations of previous agents: Bio-Descaling Powder (BDP) toothpaste is a new toothpaste (Visionaturolab Inc., QC, Canada) that aims to remove dental calculus. In a clinical trial, the calculus removed using D-Tart toothpaste was five times higher than that removed with Colgate Total® toothpaste.

Periodontal diseases (gingivitis and periodontitis) are amongst the most prevalent oral diseases worldwide and in North America, in Europe and in Spain. 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 periodontitis. 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 USA showed that 47.2% of adults aged 30 years and older have some form of periodontitis and 70.1% of adults 65 years and older have periodontal disease. The estimates also showed that the expenditure for periodontal treatments in the USA is about approximately $ 14.3 billion. More recently, estimations have been calculated as an estimated loss of $154.06B in the USA and €158.64B in Europe, in 2018.

Since dental calculus may play an important role in initiation and progression of periodontal diseases, investigation and investment on technologies to prevent periodontal diseases are important for any health care system and its end-users. Furthermore, the removal of dental calculus and the prevention of its formation, using an effective toothpaste, could reduce the need for professional periodontal interventions or the time of these treatments that in turn will reduce their cost and other burdens on patients.

The aim of this study will be to evaluate the efficacy of a Bio-Descaling Powder (BDP)-containing toothpaste, compared to a placebo toothpaste, in decreasing the presence of already formed dental calculus.

Interventions

• Other Bio-Descaling Powder (BDP) Toothpaste
  Participants will be provided with the toothpaste (containing Bio-Descaling Powder) and standard advice on tooth brushing for those patients not enrolled in a SPC program (modified Stillman brushing technique, starting with the lower arch, brushing for 2 minutes, twice daily), and the use of 1 gr (pea size) of the assigned toothpaste. Patients' interdental hygiene habits will not be modified. The participant will be asked to mark a calendar each time they brushed their teeth with the allocated t
• Other Placebo toothpaste
  Participants will receive a placebo toothpaste provided in identical packaging and standard advice on tooth brushing for those patients not enrolled in a SPC program (modified Stillman brushing technique, starting with the lower arch, brushing for 2 minutes, twice daily), and the use of 1 gr (pea size) of the assigned toothpaste. Patients' interdental hygiene habits will not be modified. The participant will be asked to mark a calendar each time they brushed their teeth with the allocated toothp

Primary outcome measures

• Change in dental calculus accumulation [Time frame: From Baseline to 6 weeks]
• Change in gingival inflammation [Time frame: From baseline to 6 weeks]

Secondary outcome measures (12)

• Change in plaque levels [Time frame: From baseline to 6 weeks]
• Change in extrinsic stains [Time frame: From baseline to 6 weeks]
• Change in Probing Pocket Depth [Time frame: from baseline to 6 weeks]
• Change in gingival recession [Time frame: From Baseline to 6 weeks]
• Acidity (pH) of the participants' saliva [Time frame: From baseline to 6 weeks]
• Patient-reported taste acceptability of the assigned toothpaste [Time frame: at the 3-week and 6-week visit]
• Patient-reported texture acceptability of the assigned toothpaste [Time frame: at the 3-week and 6-week visit]
• Patient-reported perception of tooth cleanliness after using the assigned toothpaste [Time frame: at the 3-week and 6-week visit]
• Patient-reported perception of healthier teeth after using the assigned toothpaste [Time frame: at the 3-week and 6-week visit]
• Patient-reported perception of fresh breath after using the assigned toothpaste [Time frame: at the 3- and 6-week visit]
• Patient-reported perception of the effectiveness of the assigned toothpaste in removing dental plaque [Time frame: at the 3- and 6-week visit]
• Patient-reported perception of the effectiveness of the assigned toothpaste in removing dental calculus [Time frame: at the 3- and 6-week visit]

Eligibility criteria

Inclusion criteria

Patients with a healthy but reduced periodontium undergoing a supportive periodontal care (SPC) program and/or patients with biofilm induced gingivitis, fulfilling the following 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.
• Agree to follow the study instructions, including adherence to study arm treatment, for the study timeline.

Exclusion criteria

Subjects will be excluded from participating in the study if:

• 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Triple blind

Primary purpose

Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07689071 · 24/825-EC_X

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗