Oral HealthPhase 4NCT06148662
The Effect of Oral Sprays on Salivary pH
A Phase 4 study testing Dental foam "Biorepair PERIBIOMA", Dental foam "WATER:DENT" and Dental spray "BUCCOTHERM" in people with Oral Health, run by I.M. Sechenov First Moscow State Medical University at 1 site in Russia.
Trial summary
The aim of the study is to assess the effect of oral foams on salivary pH changes after Coca-cola consumption in young adults. Read more about this study
- Who is it for?
- Ages 18 to 44 yearsHealthy volunteers can take part
- Conditions the study is for
- Oral Health
- What is being tested?
- Dental foam "Biorepair PERIBIOMA", Dental foam "WATER:DENT" and Dental spray "BUCCOTHERM"
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteRussia
- Study dates
- 1 Dec 2023to 25 Jan 2024
- 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 18 to 44 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Females and males
- Aged between 18-44 years
- Willingness to comply with all study procedures and availability for the duration of the study.
- Subjects who signed informed consent
Who cannot join
- History of chemotherapy or radiotherapy;
- An oral mucosa pathology;
- Orthodontic treatment within the previous 3 months;
- Dental bleaching within the previous 3 months;
- Withdrawal of consent;
- Patient refusal to continue participation in the study;
- Detection of an allergic reaction to any components of the dental foams or carbonated drinks used in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Oral Sprays on Salivary pH Changes After Coca-cola Consumption
The aim of the study is to assess the effect of oral foams on salivary pH changes after Coca-cola consumption in young adults.
Read the detailed description
This will be a cross-over clinical trial assessing the effect of oral foams containing zink hydroxiapatite and probiotics (Lactobacillus, Bifidobacterium), Olaflur (amino fluoride), and oral spray with alkaline thermal water. The study will be conducted in six visits over a period of 1.5 months. After enrolment, dental examination will be performed using the following indices: DMFT, OHI-S index, Bleeding index. Saliva buffer capacity, salivary flow rate, and baseline salivary pH will be measured. Salivary pH changes will be registered after consumption of Coca-cola alone or followed by each of the tested products application.
- Conditions
- Oral Health
- Being tested
- No intervention (negative control), Water (positive control), Dental foam "Biorepair PERIBIOMA", Dental foam "WATER:DENT", Dental spray "BUCCOTHERM"
- Keywords
- Coca-cola, salivary buffer capacity, salivary pH, oral foams
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No intervention (negative control)Other
The participants will be asked to hold 20 ml of "coca-cola" in their mouth for 30 seconds.
Water (positive control)Other
The participants will be asked to hold 20 ml of "coca-cola" in their mouth for 30 seconds. Then, participants will to rinse their mouth with tap water 60 seconds.
Dental foam "Biorepair PERIBIOMA"Drug
The participants will be asked to hold 20 ml of "coca-cola" in their mouth for 30 seconds.
Then, participants will use a dental foam "Biorepair PERIBIOMA" to rinse their mouth. They should rinse their mouth for 60 seconds and then spit out the foam.
Dental foam "WATER:DENT"Drug
The participants will be asked to hold 20 ml of "coca-cola" in their mouth for 30 seconds.
Then, participants will use a dental foam "WATER:DENT" to rinse their mouth. They should rinse their mouth for 60 seconds and then spit out the foam.
Dental spray "BUCCOTHERM"Drug
The participants will be asked to hold 20 ml of "coca-cola" in their mouth for 30 seconds.
Then, participants will use a dental spray "BUCCOTHERM" to rinse their mouth. They should rinse their mouth for 60 seconds and then spit out the foam.
| Study group | Role | What they receive |
|---|---|---|
| No intervention (negative control) | Experimental | Negative control Receives: Other: No intervention (negative control) |
| Water (positive control) | Experimental | Tap water Receives: Other: Water (positive control) |
| Dental foam "Biorepair PERIBIOMA" | Experimental | Ingredients:
Aqua, Sorbitol, Xylitol, Zinc Hydroxyapatite, Aroma, Pistacia Lentiscus (Mastic) Gum Oil, Lactobacillus, Bifidobacterium, Sodium Hyaluronate, Ascorbic Acid, Hamamelis Virginiana Leaf Extract, Spirulina Platensis Extract, Calendula Officinalis Flower Extract, Tocopheryl Acetate, Retinyl Palmitate, Eucalyptus Globulus Leaf Oil, PEG-40 Hydrogenated Castor Oil, Phenoxyethanol, Sodium Benzoate, Cocamidopropyl Betaine, Glycerin, Maltodextrin, Sodium Saccharin, Helianthus Annuus Seed Oil, Potassium Sorbate, BHT, Limonene, CI 16255. Receives: Drug: Dental foam "Biorepair PERIBIOMA" |
| Dental foam "WATER:DENT" | Experimental | Aqua, Xylitol, PVP, PEG-40 Hydrogenated Castor Oil, Hippophae Rhamnoides Extract, Chamomilla Recutita Extract, Sodium Benzoate, Sodium Lauryl Sulfate, Aroma, Propylene Glycol, Olaflur, Potassium Sorbate, Sodium Phosphate, Disodium Phosphate, Menthol, Bisabolol, Menthyl Lactate, PPG-26 Buteth-26, Sodium Saccharin, Sodium Methylparaben, Citric Acid, Limonene. Receives: Drug: Dental foam "WATER:DENT" |
| Spray "BUCCOTHERM" | Experimental | Aqua (Castéra-Verduzan Thermal Spring water), Alcohol, Xylitol, Glycerin, Camellia sinensis leaf water, Mentha piperita leaf water, Hydrogenated starch hydrolysate, Aqua, Aroma, Limonene, Benzyl alcohol, Dehydroacetic acid. Receives: Drug: Dental spray "BUCCOTHERM" |
What is being measured
The primary outcome is the main question the study is designed to answer.
The time required for salivary pH recovery after Coca-Cola consumption
The participants will be asked to hold 20 ml of "coca-cola" in their mouth for 30 seconds. They will be asked to spit saliva into a sterile vial at baseline (before Coca-cola consumption), immediately after Coca-Cola consumption and further every 5 minutes until the pH reaches baseline levels. Salivary pH levels will be measured with a digital pH meter. The time required for pH recovery will be registered.
Measured: 1 hour
The time required for salivary pH recovery after Coca-Cola consumption followed by oral sprays application
The participants will be asked to hold 20 ml of "coca-cola" in their mouth for 30 seconds. Then, participants will be asked to rinse their mouths with tap water (control) or each of the tested oral foams according to the manufacturer's recommendations. They will be asked to spit saliva into a sterile vial at baseline (before Coca-cola consumption), immediately after Coca-Cola consumption, immediately after oral foams/tap water rinse and further every 5 minutes until the pH reaches baseline levels. The pH levels will be measured with a digital pH meter. The time required for pH recovery will be registered.
Measured: 1 hour
Minimal value of salivary pH after Coca-Cola consumption
The participants will be asked to hold 20 ml of "coca-cola" in their mouth for 30 seconds. They will be asked to spit saliva into a sterile vial at baseline (before Coca-cola consumption), immediately after Coca-Cola consumption and further every 5 minutes until the pH reaches baseline levels. Salivary pH levels will be measured with a digital pH meter. The minimal pH value will be registered.
Measured: 1 hour
minimal value of salivary pH recovery after Coca-Cola consumption followed by oral sprays application
The participants will be asked to hold 20 ml of "coca-cola" in their mouth for 30 seconds. Then, participants will be asked to rinse their mouths with tap water (control) or each of the tested oral foams according to the manufacturer's recommendations. They will be asked to spit saliva into a sterile vial at baseline (before Coca-cola consumption), immediately after Coca-Cola consumption, immediately after oral foams/tap water rinse and further every 5 minutes until the pH reaches baseline levels. The pH levels will be measured with a digital pH meter. The minimal pH value will be registered.
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2023
- Study start1 Dec 2023
- Primary completion25 Jan 2024
- Study completion25 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Oral HealthStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- I.M. Sechenov First Moscow State Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06148662
- Sponsor's protocol ID
- 18081215
- Status last verified
- Nov 2023
- First submitted
- 20 Nov 2023
- Last updated
- 5 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Polyakova M, Egiazaryan A, Doroshina V, Zaytsev A, Malashin A, Babina K, Novozhilova N. The Effect of Oral Care Foams and a Spray on Salivary pH Changes after Exposure to Acidic Beverages in Young Adults. Dent J (Basel). 2024 Apr 3;12(4):93. doi: 10.3390/dj12040093.
PubMed 38668005
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Oral Sprays on Salivary pH Changes After Coca-cola Consumption
- ClinicalTrials.gov ID
- NCT06148662
- Acronym / sponsor ID
- 18081215
- Conditions
- Oral Health
- Keywords
- Coca-cola, salivary buffer capacity, salivary pH, oral foams
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- I.M. Sechenov First Moscow State Medical UniversityUniversity, hospital or other
- Study start
- 1 Dec 2023 (actual)
- Primary completion
- 25 Jan 2024 (actual)
- Study completion
- 25 Jan 2024 (actual)
- First posted
- 28 Nov 2023 (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 assess the effect of oral foams on salivary pH changes after Coca-cola consumption in young adults.
Detailed description
This will be a cross-over clinical trial assessing the effect of oral foams containing zink hydroxiapatite and probiotics (Lactobacillus, Bifidobacterium), Olaflur (amino fluoride), and oral spray with alkaline thermal water. The study will be conducted in six visits over a period of 1.5 months. After enrolment, dental examination will be performed using the following indices: DMFT, OHI-S index, Bleeding index. Saliva buffer capacity, salivary flow rate, and baseline salivary pH will be measured. Salivary pH changes will be registered after consumption of Coca-cola alone or followed by each of the tested products application.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| No intervention (negative control) | Experimental | Other: No intervention (negative control)Negative control |
| Water (positive control) | Experimental | Other: Water (positive control)Tap water |
| Dental foam "Biorepair PERIBIOMA" | Experimental | Drug: Dental foam "Biorepair PERIBIOMA"Ingredients: Aqua, Sorbitol, Xylitol, Zinc Hydroxyapatite, Aroma, Pistacia Lentiscus (Mastic) Gum Oil, Lactobacillus, Bifidobacterium, Sodium Hyaluronate, Ascorbic Acid, Hamamelis Virginiana Leaf Extract, Spirulina Platensis Extract, Calendula Officinalis Flower Extract, Tocopheryl Acetate, Retinyl Palmitate, Eucalyptus Globulus Leaf Oil, PEG-40 Hydrogenated Castor Oil, Phenoxyethanol, Sodium Benzoate, Cocamidopropyl Betaine, Glycerin, Maltodextrin, Sodium Saccharin, Helianthus Annuus Seed Oil, Potassium Sorbate, BHT, Limonene, CI 16255. |
| Dental foam "WATER:DENT" | Experimental | Drug: Dental foam "WATER:DENT"Aqua, Xylitol, PVP, PEG-40 Hydrogenated Castor Oil, Hippophae Rhamnoides Extract, Chamomilla Recutita Extract, Sodium Benzoate, Sodium Lauryl Sulfate, Aroma, Propylene Glycol, Olaflur, Potassium Sorbate, Sodium Phosphate, Disodium Phosphate, Menthol, Bisabolol, Menthyl Lactate, PPG-26 Buteth-26, Sodium Saccharin, Sodium Methylparaben, Citric Acid, Limonene. |
| Spray "BUCCOTHERM" | Experimental | Drug: Dental spray "BUCCOTHERM"Aqua (Castéra-Verduzan Thermal Spring water), Alcohol, Xylitol, Glycerin, Camellia sinensis leaf water, Mentha piperita leaf water, Hydrogenated starch hydrolysate, Aqua, Aroma, Limonene, Benzyl alcohol, Dehydroacetic acid. |
Who may qualify
- Ages
- 18 to 44 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Females and males
- Aged between 18-44 years
- Willingness to comply with all study procedures and availability for the duration of the study.
- Subjects who signed informed consent
Key exclusion criteria (7 listed)
- History of chemotherapy or radiotherapy;
- An oral mucosa pathology;
- Orthodontic treatment within the previous 3 months;
- Dental bleaching within the previous 3 months;
- Withdrawal of consent;
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 |
|---|---|---|
| No intervention (negative control)The participants will be asked to hold 20 ml of "coca-cola" in their mouth for 30 seconds. | Other | No intervention (negative control) |
| Water (positive control)The participants will be asked to hold 20 ml of "coca-cola" in their mouth for 30 seconds. Then, participants will to rinse their mouth with tap water 60 seconds. | Other | Water (positive control) |
| Dental foam "Biorepair PERIBIOMA"The participants will be asked to hold 20 ml of "coca-cola" in their mouth for 30 seconds. Then, participants will use a dental foam "Biorepair PERIBIOMA" to rinse their mouth. They should rinse their mouth for 60 seconds and then spit out the foam. | Drug | Dental foam "Biorepair PERIBIOMA" |
| Dental foam "WATER:DENT"The participants will be asked to hold 20 ml of "coca-cola" in their mouth for 30 seconds. Then, participants will use a dental foam "WATER:DENT" to rinse their mouth. They should rinse their mouth for 60 seconds and then spit out the foam. | Drug | Dental foam "WATER:DENT" |
| Dental spray "BUCCOTHERM"The participants will be asked to hold 20 ml of "coca-cola" in their mouth for 30 seconds. Then, participants will use a dental spray "BUCCOTHERM" to rinse their mouth. They should rinse their mouth for 60 seconds and then spit out the foam. | Drug | Spray "BUCCOTHERM" |
Primary outcome
The time required for salivary pH recovery after Coca-Cola consumption
Time frame: 1 hour
The participants will be asked to hold 20 ml of "coca-cola" in their mouth for 30 seconds. They will be asked to spit saliva into a sterile vial at baseline (before Coca-cola consumption), immediately after Coca-Cola consumption and further every 5 minutes until the pH reaches baseline levels. Salivary pH levels will be measured with a digital pH meter. The time required for pH recovery will be registered.
The time required for salivary pH recovery after Coca-Cola consumption followed by oral sprays application
Time frame: 1 hour
The participants will be asked to hold 20 ml of "coca-cola" in their mouth for 30 seconds. Then, participants will be asked to rinse their mouths with tap water (control) or each of the tested oral foams according to the manufacturer's recommendations. They will be asked to spit saliva into a sterile vial at baseline (before Coca-cola consumption), immediately after Coca-Cola consumption, immediately after oral foams/tap water rinse and further every 5 minutes until the pH reaches baseline levels. The pH levels will be measured with a digital pH meter. The time required for pH recovery will be registered.
Minimal value of salivary pH after Coca-Cola consumption
Time frame: 1 hour
The participants will be asked to hold 20 ml of "coca-cola" in their mouth for 30 seconds. They will be asked to spit saliva into a sterile vial at baseline (before Coca-cola consumption), immediately after Coca-Cola consumption and further every 5 minutes until the pH reaches baseline levels. Salivary pH levels will be measured with a digital pH meter. The minimal pH value will be registered.
minimal value of salivary pH recovery after Coca-Cola consumption followed by oral sprays application
Time frame: 1 hour
The participants will be asked to hold 20 ml of "coca-cola" in their mouth for 30 seconds. Then, participants will be asked to rinse their mouths with tap water (control) or each of the tested oral foams according to the manufacturer's recommendations. They will be asked to spit saliva into a sterile vial at baseline (before Coca-cola consumption), immediately after Coca-Cola consumption, immediately after oral foams/tap water rinse and further every 5 minutes until the pH reaches baseline levels. The pH levels will be measured with a digital pH meter. The minimal pH value will be registered.
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 5 Mar 2024.
- Derived from this study: PubMed 38668005Polyakova M, Egiazaryan A, Doroshina V, Zaytsev A, Malashin A, Babina K, Novozhilova N. The Effect of Oral Care Foams and a Spray on Salivary pH Changes after Exposure to Acidic Beverages in Young Adults. Dent J (Basel). 2024 Apr 3;12(4):93. doi: 10.3390/dj12040093.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Dental foam "Biorepair PERIBIOMA", Dental foam "WATER:DENT" and Dental spray "BUCCOTHERM" in people with Oral Health, 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 7 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 5 Mar 2024. 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?
The time required for salivary pH recovery after Coca-Cola consumption (time frame: 1 hour). The study lists 4 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 NCT06148662, which also lists 1 linked publication.
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 5 Mar 2024.