Toothpastes With Thermal Water for Oral Health

NCT05623761 | Completed Phase 4

• 1 other identifier: 18081212
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Gingivitis; Dentin Hypersensitivity

Keywords

gingivitis; dentin sensitivity; thermal water; toothpaste; fluoride

Outcome Measures

Primary Outcomes (3)

• Evaluation of gingival inflammation by Modified Gingival Index (MGI)

  MGI is used to assess visual symptoms of gingivitis on facial and lingual surfaces of each scorable tooth (whole mouth). Two scores are recorded buccally/labially, two scores lingually/palatally. Values are presented as means across all tooth surfaces with minimum and maximum scores in agreement with minimum and maximum index values (i.e., 0-4). Scoring is performed using standard dental light:0=absence of inflammation,1=mild inflammation;slight change in color,little change in color; little change in texture of any portion of the marginal or papillary gingival unit,2=mild inflammation; criteria as above plus the entire marginal or papillar gingival unit,3=moderate inflammation;glazing, redness, edema, and/or hypertrophy of the marginal or papillary gingival unit,4=severe inflammation; marked redness, edema and/or hypertrophy of the marginal or papillary gingival unit,spontaneous bleeding,congestion,or ulceration. Lower scores indicate better results.

  4 weeks after the baseline

• Evaluation of gingival inflammation by Bleeding Inde

  BI is used to assess bleeding elicited on probing as a measure of gingival condition. Gingivae are air dried and examiner assesses bleeding using a probe which is gently inserted into gingival crevice to depth of app 1 mm and run around tooth (angle of app 60 deg to long axis of tooth), gently stretching epithelium while sweeping from interproximal to interproximal along sulcular epithelium. BI is assessed on facial and lingual gingival surfaces of each scorable tooth (whole mouth). 3 scores are recorded buccally/ labially, 3scores lingually/ palatally. All scorable teeth in one quadrant are probed first (app 30 sec) before recording number of gingival units which bleed. Values are presented as means across all tooth surfaces with minimum and maximum scores in agreement with minimum and maximum index values (i.e., 0-2). BI score:0=no bleeding after 30 sec, 1=bleeding upon probing after 30 sec,2=immediate bleeding. Lower scores indicate better results.

  4 weeks after the baseline

• Evaluation of DH according to Shiff sensitivity score

  First, the tooth is isolated by the cotton roll from the adjacent teeth. Next, a blast of air from a standard dental unit syringe at 60 ± 5 psi at 18-22 °C is directed onto the exposed middle 1/3 buccal surface for 1 s at a distance of approximately 10 mm. Then, each patient reports the sensitivity he/she sensed using Schiff Cold Air Sensitivity scale scored from 0 to 3: score "0" means no response, score "1" means response without request of discontinuation of stimulus, score "2" means response with request of discontinuation of stimulus, and score "3" means pain with request of discontinuation of stimuli. Lower scores indicate better results.

  4 weeks after the baseline

Secondary Outcomes (2)

• Evaluation of oral hygiene level according to Navi-Rustogi index

  4 weeks after the baseline

• Evaluation of salivary pH

  3 minutes after baseline (after toothbrushing)

Study Arms (2)

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

ACTIVE COMPARATOR

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

Drug: BUCCOTHERM® Sensitive Gums with Fluoride

Group 2 - toothpaste containing thermal water of Castera-Verduzan

ACTIVE COMPARATOR

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

Drug: BUCCOTHERM® Sensitive Gums Fluoride-Free

Interventions

BUCCOTHERM® Sensitive Gums with Fluoride DRUG

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

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

BUCCOTHERM® Sensitive Gums Fluoride-Free DRUG

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

Group 2 - toothpaste containing thermal water of Castera-Verduzan

Eligibility Criteria

• Age: 20 Years - 25 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• I.M. Sechenov First Moscow State Medical University: lead

Study Sites (1)

Institute of Dentistry of Sechenov University

Moscow, 121059, Russia

Location

Related Publications (3)

• Makeeva IM, Polyakova MA, Doroshina VY, Turkina AY, Babina KS, Arakelyan MG. [Comparative effectiveness of therapeutic toothpastes with fluoride and hydroxyapatite]. Stomatologiia (Mosk). 2018;97(5):34-40. doi: 10.17116/stomat20189705134. Russian.

  PMID: 30346419 BACKGROUND

• Makeeva IM, Polyakova MA, Doroshina VY, Sokhova IA, Arakelyan MG, Makeeva MK. [Efficiency of paste and suspension with nano-hydroxyapatite on the sensitivity of teeth with gingival recession]. Stomatologiia (Mosk). 2018;97(4):23-27. doi: 10.17116/stomat20189704123. Russian.

  PMID: 30199063 BACKGROUND

• Polyakova M, Sokhova I, Doroshina V, Arakelyan M, Novozhilova N, Babina K. The Effect of Toothpastes Containing Hydroxyapatite, Fluoroapatite, and Zn-Mg-hydroxyapatite Nanocrystals on Dentin Hypersensitivity: A Randomized Clinical Trial. J Int Soc Prev Community Dent. 2022 Apr 8;12(2):252-259. doi: 10.4103/jispcd.JISPCD_333_21. eCollection 2022 Mar-Apr.

  PMID: 35462739 BACKGROUND

MeSH Terms

Conditions

Gingivitis; Dentin Sensitivity

Interventions

Fluorides

Condition Hierarchy (Ancestors)

Infections; Gingival Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Tooth Diseases

Intervention Hierarchy (Ancestors)

Anions; Ions; Electrolytes; Inorganic Chemicals; Hydrofluoric Acid; Fluorine Compounds

Study Officials

• Irina M Makeeva

  +79037280722

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: double-blind, randomized, two-arm parallel-group study

Study Record Dates

• First Submitted: November 7, 2022
• First Posted: November 21, 2022
• Study Start: November 1, 2022
• Primary Completion: January 30, 2023
• Study Completion: February 15, 2023
• Last Updated: March 1, 2023

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

RU (1)