Back to resultsToothpastes With Thermal Water for Oral Health
Primary Purpose
Gingivitis, Dentin Hypersensitivity
Status
Completed
Phase
Phase 4
Locations
Russian Federation
Study Type
Interventional
Intervention
BUCCOTHERM® Sensitive Gums with Fluoride
BUCCOTHERM® Sensitive Gums Fluoride-Free
Sponsored by
About this trial
This is an interventional treatment trial for Gingivitis focused on measuring gingivitis, dentin sensitivity, thermal water, toothpaste, fluoride
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
Sites / Locations
- Institute of Dentistry of Sechenov University
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Group 1 - toothpaste containing thermal water of Castera-Verduzan and 1450 ppm Sodium fluoride
Group 2 - toothpaste containing thermal water of Castera-Verduzan
Arm Description
Subjects will receive thermal water/sodium fluoride toothpaste (BUCCOTHERM® Sensitive Gums with Fluoride)
Subjects will receive thermal water toothpaste (BUCCOTHERM® Sensitive Gums Fluoride-Free)
Outcomes
Primary Outcome Measures
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.
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.
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.
Secondary Outcome Measures
Evaluation of oral hygiene level according to Navi-Rustogi index
Nine sites per facial and lingual tooth surface are assessed, for a maximum 504 sites total (excluding 3rd molars, crowns, and surfaces with cervical restorations). Disclosed plaque is scored in each tooth area as follows: 0 = Absent; and 1 = Present. A mean plaque index (MPI) is calculated for each subject on a whole mouth basis. Lower scores indicate better results.
Evaluation of salivary pH
Unstimulated 5 ml whole saliva sample is collected in morning from 10 am to 11 am, two hours after the last meal. Participants refrain from eating, drinking, smoking, or conducting oral hygiene procedures for a minimum of 90 min prior to salivary collection. Participants are comfortably seated, are asked to avoid swallowing saliva and asked to lean forward and spit all the saliva they produced into a graduated test tube until the required volume is collected. The pH is determined immediately after the collection using a digital pH-meter.
Full Information
NCT ID
NCT05623761
First Posted
November 7, 2022
Last Updated
February 28, 2023
Sponsor
I.M. Sechenov First Moscow State Medical University
1. Study Identification
Unique Protocol Identification Number
NCT05623761
Brief Title
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
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
November 1, 2022 (Actual)
Primary Completion Date
January 30, 2023 (Actual)
Study Completion Date
February 15, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
I.M. Sechenov First Moscow State Medical University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gingivitis, Dentin Hypersensitivity
Keywords
gingivitis, dentin sensitivity, thermal water, toothpaste, fluoride
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
double-blind, randomized, two-arm parallel-group study
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
84 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group 1 - toothpaste containing thermal water of Castera-Verduzan and 1450 ppm Sodium fluoride
Arm Type
Active Comparator
Arm Description
Subjects will receive thermal water/sodium fluoride toothpaste (BUCCOTHERM® Sensitive Gums with Fluoride)
Arm Title
Group 2 - toothpaste containing thermal water of Castera-Verduzan
Arm Type
Active Comparator
Arm Description
Subjects will receive thermal water toothpaste (BUCCOTHERM® Sensitive Gums Fluoride-Free)
Intervention Type
Drug
Intervention Name(s)
BUCCOTHERM® Sensitive Gums with Fluoride
Intervention Description
Toothbrushing using standardised technique and pear-sized amount of toothpaste BUCCOTHERM® Sensitive Gums with Fluoride twice daily for 1 month.
Intervention Type
Drug
Intervention Name(s)
BUCCOTHERM® Sensitive Gums Fluoride-Free
Intervention Description
Toothbrushing using standardised technique and pear-sized amount of toothpaste BUCCOTHERM® Sensitive Gums Fluoride-Free twice daily for 1 month.
Primary Outcome Measure Information:
Title
Evaluation of gingival inflammation by Modified Gingival Index (MGI)
Description
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.
Time Frame
4 weeks after the baseline
Title
Evaluation of gingival inflammation by Bleeding Inde
Description
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.
Time Frame
4 weeks after the baseline
Title
Evaluation of DH according to Shiff sensitivity score
Description
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.
Time Frame
4 weeks after the baseline
Secondary Outcome Measure Information:
Title
Evaluation of oral hygiene level according to Navi-Rustogi index
Description
Nine sites per facial and lingual tooth surface are assessed, for a maximum 504 sites total (excluding 3rd molars, crowns, and surfaces with cervical restorations). Disclosed plaque is scored in each tooth area as follows: 0 = Absent; and 1 = Present. A mean plaque index (MPI) is calculated for each subject on a whole mouth basis. Lower scores indicate better results.
Time Frame
4 weeks after the baseline
Title
Evaluation of salivary pH
Description
Unstimulated 5 ml whole saliva sample is collected in morning from 10 am to 11 am, two hours after the last meal. Participants refrain from eating, drinking, smoking, or conducting oral hygiene procedures for a minimum of 90 min prior to salivary collection. Participants are comfortably seated, are asked to avoid swallowing saliva and asked to lean forward and spit all the saliva they produced into a graduated test tube until the required volume is collected. The pH is determined immediately after the collection using a digital pH-meter.
Time Frame
3 minutes after baseline (after toothbrushing)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Irina M Makeeva
Organizational Affiliation
+79037280722
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institute of Dentistry of Sechenov University
City
Moscow
ZIP/Postal Code
121059
Country
Russian Federation
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
30346419
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.
Results Reference
background
PubMed Identifier
30199063
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.
Results Reference
background
PubMed Identifier
35462739
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.
Results Reference
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Toothpastes With Thermal Water for Oral Health
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