Bio-Descaling Toothpaste for Dental Calculus Reduction

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

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 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.

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 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.

Sponsors & Collaborators

• Visionaturolab INC.

  collaborator UNKNOWN

• Universidad Complutense de Madrid

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2026-07-31

Primary Completion

2027-01-31

Completion

2027-01-31