GingivitisPhase 4NCT05623761
Toothpastes With Thermal Water for Oral Health
A Phase 4 study testing BUCCOTHERM® Sensitive Gums with Fluoride and BUCCOTHERM® Sensitive Gums Fluoride-Free in people with Gingivitis and Dentin Hypersensitivity, run by I.M. Sechenov First Moscow State Medical University at 1 site in Russia.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 25 years
- Conditions the study is for
- Gingivitis, Dentin Hypersensitivity
- What is being tested?
- BUCCOTHERM® Sensitive Gums with Fluoride and BUCCOTHERM® Sensitive Gums Fluoride-Free
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteRussia
- Study dates
- 1 Nov 2022to 15 Feb 2023
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 25 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 16Show fewer
- 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 locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Gingivitis, Dentin Hypersensitivity
- Being tested
- BUCCOTHERM® Sensitive Gums with Fluoride, BUCCOTHERM® Sensitive Gums Fluoride-Free
- Keywords
- gingivitis, dentin sensitivity, thermal water, toothpaste, fluoride
- Medical subject headings
- Gingivitis, Dentin Sensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BUCCOTHERM® Sensitive Gums with FluorideDrug
Toothbrushing using standardised technique and pear-sized amount of toothpaste BUCCOTHERM® Sensitive Gums with Fluoride twice daily for 1 month.
BUCCOTHERM® Sensitive Gums Fluoride-FreeDrug
Toothbrushing using standardised technique and pear-sized amount of toothpaste BUCCOTHERM® Sensitive Gums Fluoride-Free twice daily for 1 month.
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: 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) Receives: Drug: BUCCOTHERM® Sensitive Gums Fluoride-Free |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 4 weeks after the baseline
Secondary outcomes (2)
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.
Measured: 4 weeks after the baseline
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.
Measured: 3 minutes after baseline (after toothbrushing)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2022
- Study start1 Nov 2022
- Primary completion30 Jan 2023
- Study completion15 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for GingivitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- double-blind, randomized, two-arm parallel-group study
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- I.M. Sechenov First Moscow State Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Irina M Makeeva, Principal investigator, +79037280722
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05623761
- Sponsor's protocol ID
- 18081212
- Status last verified
- Nov 2022
- First submitted
- 7 Nov 2022
- Last updated
- 1 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 30346419Makeeva 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.
PubMed 30199063Polyakova 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.
PubMed 35462739
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05623761
- Acronym / sponsor ID
- 18081212
- Conditions
- Gingivitis, Dentin Hypersensitivity
- Keywords
- gingivitis, dentin sensitivity, thermal water, toothpaste, fluoride
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- I.M. Sechenov First Moscow State Medical UniversityUniversity, hospital or other
- Study start
- 1 Nov 2022 (actual)
- Primary completion
- 30 Jan 2023 (actual)
- Study completion
- 15 Feb 2023 (actual)
- First posted
- 21 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- double-blind, randomized, two-arm parallel-group study
| Arm | Type | Receives |
|---|---|---|
| Group 1 - toothpaste containing thermal water of Castera-Verduzan and 1450 ppm Sodium fluoride | Active comparator | Drug: BUCCOTHERM® Sensitive Gums with FluorideSubjects will receive thermal water/sodium fluoride toothpaste (BUCCOTHERM® Sensitive Gums with Fluoride) |
| Group 2 - toothpaste containing thermal water of Castera-Verduzan | Active comparator | Drug: BUCCOTHERM® Sensitive Gums Fluoride-FreeSubjects will receive thermal water toothpaste (BUCCOTHERM® Sensitive Gums Fluoride-Free) |
Who may qualify
- Ages
- 20 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BUCCOTHERM® Sensitive Gums with FluorideToothbrushing using standardised technique and pear-sized amount of toothpaste BUCCOTHERM® Sensitive Gums with Fluoride twice daily for 1 month. | Drug | Group 1 - toothpaste containing thermal water of Castera-Verduzan and 1450 ppm Sodium fluoride |
| BUCCOTHERM® Sensitive Gums Fluoride-FreeToothbrushing using standardised technique and pear-sized amount of toothpaste BUCCOTHERM® Sensitive Gums Fluoride-Free twice daily for 1 month. | Drug | Group 2 - toothpaste containing thermal water of Castera-Verduzan |
Primary outcome
Evaluation of gingival inflammation by Modified Gingival Index (MGI)
Time frame: 4 weeks after the baseline
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
Time frame: 4 weeks after the baseline
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
Time frame: 4 weeks after the baseline
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.
2 secondary outcomes
Evaluation of oral hygiene level according to Navi-Rustogi index
Time frame: 4 weeks after the baseline
Evaluation of salivary pH
Time frame: 3 minutes after baseline (after toothbrushing)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2023.
- Background: PubMed 30346419Makeeva 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.
- Background: PubMed 30199063Makeeva 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.
- Background: PubMed 35462739Polyakova 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Irina M Makeeva principal investigator
+79037280722
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing BUCCOTHERM® Sensitive Gums with Fluoride and BUCCOTHERM® Sensitive Gums Fluoride-Free in people with Gingivitis and Dentin Hypersensitivity, run by I.M. Sechenov First Moscow State Medical University at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of gingival inflammation by Modified Gingival Index (MGI) (time frame: 4 weeks after the baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05623761, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Mar 2023.