Toothpastes With Thermal Water for Oral Health

I.M. Sechenov First Moscow State Medical University

Status and phase: Completed; Phase 4

Conditions: Dentin Hypersensitivity; Gingivitis

Treatments: Drug: BUCCOTHERM® Sensitive Gums with Fluoride; Drug: BUCCOTHERM® Sensitive Gums Fluoride-Free

Study type: Interventional

Funder types: Other

Identifiers

NCT05623761

18081212

Details and patient eligibility

About

The aim of the study is to compare the effect of toothpastes containing thermal water of Castera-Verduzan with 1450 ppm fluoride and without fluorinated derivatives on oral hygiene, gingivitis, and dentin hypersensitivity in young adults.

Full description

This will be a double-blind, randomized, two-arm parallel-group study of the effect of toothpastes containing thermal water of Castera-Verduzan with 1450 ppm fluoride and without fluorinated derivatives. The groups will include adults with gingivitis and dentinal hypersensitivity (DH) diagnosed clinically. To assess the effect of the toothpastes, the following parameters will be used: gingival health (modified gingival index, MGI; gingival bleeding index, BI), dentin sensitivity (Shiff's index, VAS), oral hygiene level (Navi-Rustogi index), and salivary pH.

Enrollment: 84 patients

Sex: All

Ages: 20 to 25 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• aged between 20-25 years
• signed an approved Informed Consent Form, authorizing the participation in the trial and the use of the results of the trial for educational purposes and for the publication
• the diagnosis of gingivitis stated clinically
• at least one tooth with the diagnosis of dentin hypersensitivity stated clinically

Exclusion criteria

• medical and pharmacotherapeutic histories that may compromise the protocol (pregnancy or breastfeeding, psychiatric disorders, allergies to toothpastes ingredients, eating disorders)
• systemic conditions that are etiologic to dentin hypersensitivity (e.g., chronic acid regurgitation)

history of chemotherapy or radiotherapy

• taking antibiotic, anti-inflammatory, or anti-coagulant medications 4 weeks prior to or after the baseline visit
• oral mucosa pathology
• periodontal surgery in the preceding 3 months
• orthodontic appliance treatment within previous 3 months
• teeth or supporting structures with any other painful pathology or defects
• taking any other agents for DH management 4 weeks prior to or after the baseline visit
• extensively restored teeth and those with restorations extending into the

cervical area

• dental bleaching within previous 3 months
• subject withdrawal of consent
• subject is not compliant with study procedures
• adverse Event that in the opinion of the Investigator would be in the best interest

of the subject to discontinue study participation

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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84 participants in 2 patient groups

Group 1 - toothpaste containing thermal water of Castera-Verduzan and 1450 ppm Sodium fluoride

Active Comparator group

Description:

Subjects will receive thermal water/sodium fluoride toothpaste (BUCCOTHERM® Sensitive Gums with Fluoride)

Treatment:

Drug: BUCCOTHERM® Sensitive Gums with Fluoride

Group 2 - toothpaste containing thermal water of Castera-Verduzan

Active Comparator group

Description:

Subjects will receive thermal water toothpaste (BUCCOTHERM® Sensitive Gums Fluoride-Free)

Treatment:

Drug: BUCCOTHERM® Sensitive Gums Fluoride-Free