Bio-Descaling Toothpaste for Dental Calculus Reduction (AntiCal)
Efficacy of a Novel Toothpaste Containing a Bio-Descaling Powder (BDP) in Reducing Dental Calculus: A Double Blind Randomized Controlled Clinical Trial
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.
研究概览
详细说明
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.
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名：Mariano Sanz
- 电话号码：913942010
- 邮箱：marsan@ucm.es
参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
描述
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.
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：三倍
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：Bio-Descaling Powder (BDP) Toothpaste
Participants assigned to this arm will use a toothpaste containing Bio-Descaling Powder (BDP) for 6 weeks according to standardized oral hygiene instructions.
Clinical assessments will be performed at baseline, 3 weeks, and 6 weeks to evaluate dental calculus accumulation, gingival inflammation, plaque levels, and other periodontal parameters.
At the end of the trial (6-week visit), the participants will be received professional mechanical plaque removal (PMPR).
|
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 toothpaste, and to bring the toothpaste tubes and tooth brushes for assessment at each evaluation session in order to monitor their adherence to the trial instructions.
They will be instructed to not use mouthwashes or other toothpastes for the duration of the study.
|
|
安慰剂比较：Placebo Toothpaste
Participants assigned to this arm will use a placebo toothpaste with identical packaging and standardized oral hygiene instructions for 6 weeks.
Clinical assessments will be performed at baseline, 3 weeks, and 6 weeks to evaluate dental calculus accumulation, gingival inflammation, plaque levels, and other periodontal parameters.
At the end of the trial (6-week visit), the participants will be received professional mechanical plaque removal (PMPR).
|
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 toothpaste, and to bring the toothpaste tubes and tooth brushes for assessment at each evaluation session in order to monitor their adherence to the trial instructions.
They will be instructed to not use mouthwashes or other toothpastes for the duration of the study.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change in dental calculus accumulation
大体时间：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. |
From Baseline to 6 weeks
|
|
Change in gingival inflammation
大体时间：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.
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From baseline to 6 weeks
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change in plaque levels
大体时间：From baseline to 6 weeks
|
The plaque accumulated on the buccal and lingual surfaces of all teeth will be assessed using a dichotomous plaque index (PlI), (Quigley & Hein, 1962; Turesky, Gilmore, & Glickman, 1970), assessing six areas per tooth, visually, and/or with the periodontal probe, identifying the presence of plaque.
|
From baseline to 6 weeks
|
|
Change in extrinsic stains
大体时间：From baseline to 6 weeks
|
The extrinsic stains on the buccal surfaces of the lower and upper central and lateral incisors will be quantified using the Gründemann (Grundemann, Timmerman, Ijzerman, van der Weijden, & van der Weijden, 2000) modification of staining index (GMSI), modified by Koertge and Gunsolley (Koertge, Gunsolley, Domke, & Nelson, 1993), by evaluating one standardized clinical photograph, with teeth in edge-to-edge bite.
|
From baseline to 6 weeks
|
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Change in Probing Pocket Depth
大体时间：from baseline to 6 weeks
|
Probing Pocket Depth (PPD) will be measured in millimeters at six sites per tooth using a periodontal probe.
PPD is defined as the distance from the gingival margin to the bottom of the periodontal pocket.
|
from baseline to 6 weeks
|
|
Change in gingival recession
大体时间：From Baseline to 6 weeks
|
Gingival Recession (REC) will be measured in millimeters at six sites per tooth as the distance from the cemento-enamel junction to the gingival margin, allowing for the calculation of clinical attachment level (CAL).
|
From Baseline to 6 weeks
|
|
Acidity (pH) of the participants' saliva
大体时间：From baseline to 6 weeks
|
The acidity (pH) of the participants' saliva will be measured using a pH meter, after collecting unstimulated saliva samples for 5 min (in order to collect 2.5 ml).
Unstimulated whole saliva, directly expectorated, will be collected in sterile test tubes.
The subjects will be instructed to fast (not drinking coffee or tea, or eating), and not to smoke for at least one hour prior to the saliva collection\.
Salivary pH will be measured after collection using a pH meter (Crison® micropH 2001 pH-meter).
Samples will be immediately transported to the laboratory for pH evaluation, determination of volume and proper conservation for additional processing.
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From baseline to 6 weeks
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Patient-reported taste acceptability of the assigned toothpaste
大体时间：at the 3-week and 6-week visit
|
Patient-reported rating of the statement "The taste of the toothpaste is pleasant" using a 4-point Likert scale (1 = Totally disagree, 2 = Rather disagree, 3 = Rather agree, 4 = Totally agree).
A questionnaire will be used.
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at the 3-week and 6-week visit
|
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Patient-reported texture acceptability of the assigned toothpaste
大体时间：at the 3-week and 6-week visit
|
Patient-reported rating of the statement "The consistency of the toothpaste is pleasant" using a 4-point Likert scale (1 = Totally disagree to 4 = Totally agree).
|
at the 3-week and 6-week visit
|
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Patient-reported perception of tooth cleanliness after using the assigned toothpaste
大体时间：at the 3-week and 6-week visit
|
Patient-reported rating of the statement "The toothpaste provides a sensation of clean teeth" using a 4-point Likert scale (1 = Totally disagree to 4 = Totally agree).
A questionnaire will be used.
|
at the 3-week and 6-week visit
|
|
Patient-reported perception of healthier teeth after using the assigned toothpaste
大体时间：at the 3-week and 6-week visit
|
Patient-reported rating of the statement "The toothpaste provides a sensation of healthier teeth" using a 4-point Likert scale (1 = Totally disagree to 4 = Totally agree).
|
at the 3-week and 6-week visit
|
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Patient-reported perception of fresh breath after using the assigned toothpaste
大体时间：at the 3- and 6-week visit
|
Patient-reported rating of the statement "The toothpaste provides a sensation of fresh breath" using a 4-point Likert scale (1 = Totally disagree to 4 = Totally agree).
|
at the 3- and 6-week visit
|
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Patient-reported perception of the effectiveness of the assigned toothpaste in removing dental plaque
大体时间：at the 3- and 6-week visit
|
Patient-reported rating of the statement "The toothpaste effectively helps remove dental plaque" using a 4-point Likert scale (1 = Totally disagree to 4 = Totally agree).
|
at the 3- and 6-week visit
|
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Patient-reported perception of the effectiveness of the assigned toothpaste in removing dental calculus
大体时间：at the 3- and 6-week visit
|
Patient-reported rating of the statement "The toothpaste effectively helps reduce dental calculus" using a 4-point Likert scale (1 = Totally disagree to 4 = Totally agree).
|
at the 3- and 6-week visit
|
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Patient-reported tooth and oral mucosal staining after using the assigned toothpaste
大体时间：at the 3- and 6-week visit
|
Patient-reported rating of the statement "I have noticed increased staining of my teeth or oral mucosa" using a 4-point Likert scale (1 = Totally disagree, 2 = Rather disagree, 3 = Rather agree, 4 = Totally agree).
|
at the 3- and 6-week visit
|
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Patient-reported dry mouth after using the assigned toothpaste
大体时间：at the 3- and 6-week visit
|
Patient-reported rating of the statement "I have noticed a drier mouth" using a 4-point Likert scale (1 = Totally disagree to 4 = Totally agree).
|
at the 3- and 6-week visit
|
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Patient-reported altered taste perception after using the assigned toothpaste
大体时间：at the 3- and 6-week visit
|
Patient-reported rating of the statement "I have noticed changes in my perception of taste" using a 4-point Likert scale (1 = Totally disagree to 4 = Totally agree).
|
at the 3- and 6-week visit
|
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Patient-reported oral burning, soreness, or other oral mucosal problems after using the assigned toothpaste
大体时间：at the 3- and 6-week visit
|
Patient-reported rating of the statement "I have noticed burning, soreness, or other problems in my oral mucosa" using a 4-point Likert scale (1 = Totally disagree to 4 = Totally agree)
|
at the 3- and 6-week visit
|
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Overall patient satisfaction with the assigned toothpaste
大体时间：at the 3- and 6-week visit
|
Patient-reported rating of the statement "My overall evaluation of the toothpaste is very positive" using a 4-point Likert scale (1 = Totally disagree to 4 = Totally agree).
|
at the 3- and 6-week visit
|
合作者和调查者
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
关键字
其他相关的 MeSH 术语
其他研究编号
- 24/825-EC_X
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
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研究美国 FDA 监管的药品
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