Efficacy of a Novel Toothpaste Containing a Bio-Descaling Powder (BDP) in Reducing Dental Calculus: A Double Blind Randomized Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 100
- 主要终点
- Change in dental calculus accumulation
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
Participants, investigators, and outcome assessors are blinded to treatment allocation. The test and placebo toothpastes are provided in identical packaging and labeled only with a coded identification number. Allocation codes will be carried out off-site by a statistician and maintained by the collaborator (Visionaturolab Inc.). The coding for the toothpastes will be withheld from the examiners until data analysis is complete.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Change in dental calculus accumulation
时间窗: From Baseline to 6 weeks
The calculus accumulation will be measured on the lingual aspect of the six mandibular anterior teeth using the Volpe-Manhold Calculus Index score (Volpe et al., 1965). For values less than 0.5, the assessment should be 0. At this stage, dental plaque will be mechanically removed from the lingual area of the 5th sextant, by the clinician, in order to remove soft deposits, for a more accurate evaluation of the presence of calculus. After toothbrushing, the area of interest will be dried with the dental unit syringe. Furthermore, an intra oral scanner will be used to scan lower anterior teeth in order to quantify reduction in calculus volume. In addition, a photograph of the lingual side of the 5th sextant will be taken to further assess calculus presence. At the time of taking clinical photographs, their quality taken will be checked.
Change in gingival inflammation
时间窗: From baseline to 6 weeks
Bleeding on probing (BOP) by dichotomous assessment of bleeding after gentle probing, at six sites per tooth (Ainamo \& Bay, 1975). Furthermore, an intra oral scanner will be used to scan lower anterior teeth, to assess adjacent gingival tissues, in order to quantify the reduction in gingival inflammation.
次要结局
- Change in plaque levels(From baseline to 6 weeks)
- Change in extrinsic stains(From baseline to 6 weeks)
- Change in Probing Pocket Depth(from baseline to 6 weeks)
- Change in gingival recession(From Baseline to 6 weeks)
- Acidity (pH) of the participants' saliva(From baseline to 6 weeks)
- Patient-reported taste acceptability of the assigned toothpaste(at the 3-week and 6-week visit)
- Patient-reported texture acceptability of the assigned toothpaste(at the 3-week and 6-week visit)
- Patient-reported perception of tooth cleanliness after using the assigned toothpaste(at the 3-week and 6-week visit)
- Patient-reported perception of healthier teeth after using the assigned toothpaste(at the 3-week and 6-week visit)
- Patient-reported perception of fresh breath after using the assigned toothpaste(at the 3- and 6-week visit)
- Patient-reported perception of the effectiveness of the assigned toothpaste in removing dental plaque(at the 3- and 6-week visit)
- Patient-reported perception of the effectiveness of the assigned toothpaste in removing dental calculus(at the 3- and 6-week visit)
- Patient-reported tooth and oral mucosal staining after using the assigned toothpaste(at the 3- and 6-week visit)
- Patient-reported dry mouth after using the assigned toothpaste(at the 3- and 6-week visit)
- Patient-reported altered taste perception after using the assigned toothpaste(at the 3- and 6-week visit)
- Patient-reported oral burning, soreness, or other oral mucosal problems after using the assigned toothpaste(at the 3- and 6-week visit)
- Overall patient satisfaction with the assigned toothpaste(at the 3- and 6-week visit)