Clinical trial NCT05623761: Toothpastes With Thermal Water for Oral Health
Official title: The Effect of Toothpastes Based on Alkaline Thermal Water With and Without Fluorinated Derivative on Gingivitis, Dentin Hypersensitivity, and Oral Hygiene: a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Gingivitis
Dentin Hypersensitivity
Keywords: gingivitis
dentin sensitivity
thermal water
toothpaste
fluoride
Lead sponsor: I.M. Sechenov First Moscow State Medical University
Sponsor class: OTHER
First posted: 2022-11-21
Enrollment: 84
Sex: ALL
Minimum age (years): 20
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: double-blind, randomized, two-arm parallel-group study
Primary purpose: TREATMENT

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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Evaluation of gingival inflammation by Modified Gingival Index (MGI)
timeFrame: 4 weeks after the baseline
measure: Evaluation of gingival inflammation by Bleeding Inde
timeFrame: 4 weeks after the baseline
measure: Evaluation of DH according to Shiff sensitivity score
timeFrame: 4 weeks after the baseline
Secondary outcomes:
measure: Evaluation of oral hygiene level according to Navi-Rustogi index
timeFrame: 4 weeks after the baseline
measure: Evaluation of salivary pH
timeFrame: 3 minutes after baseline (after toothbrushing)
Other outcomes:
Locations:
city: Moscow
country: Russian Federation
facility: Institute of Dentistry of Sechenov University
Study officials:
affiliation: +79037280722
name: Irina M Makeeva
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.