Toothpastes With Thermal Water for Oral Health

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

84 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-11-01

Study Completion Date

2023-02-15

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Gingivitis Dentin Hypersensitivity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

double-blind, randomized, two-arm parallel-group study

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

The allocation concealment will be performed using sealed containers numbered by a "third party" (person who will not participate in the study). The toothpastes in white bottles without any titles will be placed in the containers. Each patient will receive a sealed container with a toothpaste on enrolment. Neither patients nor researchers will be aware of the type of the toothpaste used.

Study Groups

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

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

Group Type ACTIVE_COMPARATOR

BUCCOTHERM® Sensitive Gums with Fluoride

Intervention Type DRUG

Toothbrushing using standardised technique and pear-sized amount of toothpaste BUCCOTHERM® Sensitive Gums with Fluoride twice daily for 1 month.

Group 2 - toothpaste containing thermal water of Castera-Verduzan

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

Group Type ACTIVE_COMPARATOR

BUCCOTHERM® Sensitive Gums Fluoride-Free

Intervention Type DRUG

Toothbrushing using standardised technique and pear-sized amount of toothpaste BUCCOTHERM® Sensitive Gums Fluoride-Free twice daily for 1 month.

Interventions

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BUCCOTHERM® Sensitive Gums with Fluoride

Toothbrushing using standardised technique and pear-sized amount of toothpaste BUCCOTHERM® Sensitive Gums with Fluoride twice daily for 1 month.

Intervention Type DRUG

BUCCOTHERM® Sensitive Gums Fluoride-Free

Toothbrushing using standardised technique and pear-sized amount of toothpaste BUCCOTHERM® Sensitive Gums Fluoride-Free twice daily for 1 month.

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

20 Years

Maximum Eligible Age

25 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No