Bio-Descaling Toothpaste for Dental Calculus Reduction

NCT07689071 | Not Yet Recruiting DMC

• 1 other identifier: 24/825-EC_X
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Dental Calculus; Gingivitis and Periodontal Diseases; Periodontal Diseases

Keywords

dental calculus; calculus removal; Bio-descaling powder toothpaste; Periodontal Maintenance; Gingival inflammation; Supportive Periodontal Care; Periodontal diseases

Outcome Measures

Primary Outcomes (2)

• Change in dental calculus accumulation

  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

  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.

  From baseline to 6 weeks

Secondary Outcomes (17)

• 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

Study Arms (2)

Bio-Descaling Powder (BDP) Toothpaste

EXPERIMENTAL

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).

Other: Bio-Descaling Powder (BDP) Toothpaste

Placebo Toothpaste

PLACEBO COMPARATOR

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).

Other: Placebo toothpaste

Interventions

Bio-Descaling Powder (BDP) Toothpaste OTHER

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.

Bio-Descaling Powder (BDP) Toothpaste

Placebo toothpaste OTHER

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.

Placebo Toothpaste

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidad Complutense de Madrid: lead
• Visionaturolab INC.: collaborator

MeSH Terms

Conditions

Dental Calculus; Gingivitis; Periodontal Diseases

Interventions

alpha-ketoisovalerate dehydrogenase phosphatase; Toothpastes

Condition Hierarchy (Ancestors)

Dental Deposits; Tooth Diseases; Stomatognathic Diseases; Calculi; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Infections; Gingival Diseases; Mouth Diseases

Intervention Hierarchy (Ancestors)

Dentifrices; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture

Central Study Contacts

Mariano Sanz

CONTACT

913942010; marsan@ucm.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 26, 2026
• First Posted: July 8, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2027
• Last Updated: July 8, 2026

Record last verified: 2026-07