CariesPhase 1NCT03468842
Study to Evaluate the Clinical Efficacy of Streptococcus Dentisani CECT 7746 in Caries Risk Reduction
A Phase 1 study testing Probiotic in people with Caries, run by AB Biotics, SA at 1 site in Spain.
Trial summary
Exploratory, phase I study to evaluate the clinical efficacy of Streptococcus dentisani CECT 7746 in the risk reduction of caries. Patients who meet the inclusion and exclusion criteria will be randomized and receive the corresponding treatment. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Caries
- What is being tested?
- Probiotic
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 76 participants
- Where
- 1 siteSpain
- Study dates
- 13 May 2016to 20 Dec 2017
- Phase
- Phase 1
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and women between the ages of 18 and 65
- With a previous history of caries and / or active cavities
- Absence of other oral diseases
- With a basal oral pH (after brushing with only water) in saliva equal to or less than 7
Who cannot join
- Antibiotic use during the 30 days prior to the start of the study.
- Usual consumption of chlorhexidine or other mouthwashes with bactericidal active ingredients during the 30 days prior to the start of the study.
- Consumption of oral probiotics during the 30 days prior to the start of the study (Annex II)
- Pregnant or lactating women
- Participants with chronic diseases (eg diabetes, kidney problems, cancer) or who may affect the salivary flow
- Participants in chronic treatment or with medication that can reduce salivary flow, such as antidepressants or psychotropic drugs.
- Allergy to any of the ingredients of the research product
Trial locations and contacts
1 site in 1 country.
Spain1 site
Lluis Alcanyis Foundation dental clinic, University of Valencia
Valencia, 46010
About this study
Official title: Randomized, Double-blind, Placebo-controlled Parallel Group Study to Evaluate the Clinical Efficacy of Streptococcus Dentisani CECT 7746 in Caries Risk Reduction
Exploratory, phase I study to evaluate the clinical efficacy of Streptococcus dentisani CECT 7746 in the risk reduction of caries. Patients who meet the inclusion and exclusion criteria will be randomized and receive the corresponding treatment. The study will follow a randomized design, with two groups in parallel (placebo group and probiotic group) of prospective, double-blind follow-up, for a period of 45 days. The present study will be conducted in a single center and will include a total of 70 patients. The present study has a double main objective:
- Evaluate whether the administration of the probiotic S. dentisani CECT 7746 alkalizes the basal pH of saliva.
- Test the safety and tolerability of the probiotic
Read more
Secondary
- Evaluate other microbiological parameters associated with caries risk such as the presence of microorganisms such as S. mutans.
- Evaluate the presence in the mouth and colonization capacity of S. dentisani.
- Evaluate the lactic acid and the pH of the ex vivo plate before and after the administration of a sugar solution
- Evaluate the salivary pH before and after the administration of a sugar solution
- Evaluate the salivary pH before brushing with water.
- Evaluate the buffer capacity of saliva
Read the detailed description
The probiotic Streptococcus dentisani is a bacterial species present in the human oral microbial flora. It was isolated initially, as result of observation and hypothesis, of volunteers who had never developed caries. These strains have demonstrated, through in vitro studies, an enormous potential of inhibition against S. mutans, besides inhibiting the growth of other pathogens commonly present in common oral pathologies (gingivitis, periodontitis or halitosis). The probiotic product has been shown to be effective in in vitro experiments, artificial mouth models and epidemiological data, statistically significant. However, it is necessary to document the efficacy of Streptococcus dentisani in an oral application study.
Recruitment visit:
In a first visit, it will be assessed if the candidates meet all the inclusion criteria and none of the exclusion criteria. For this, a dental revision will be carried out to assess the different parameters (plaque index, gingival index and salivary flow among others), and a saliva sample will be taken after brushing with water to determine its basal pH.
Those participants who meet the criteria and provide written informed consent will be assigned to one of the two treatment groups (probiotic or placebo). The assignment will be done randomly using a computer generated list.
In this first visit, an impression of the jaw will also be made of those volunteers who meet the criteria and have been randomized. This impression will be used to manufacture custom splints that allow a more comfortable application of the treatment during the study by the participants.
A detailed list of probiotic products present in the market for oral use will be provided.
Basal visit (Day 0):
After 1-2 weeks of the recruitment visit, participants will return to the center for the baseline visit. During this visit, samples of saliva (2 ml) and plaque (from quadrants 1 and 3 on the vestibular and lingual surfaces) will be taken for the quantification and detection of S. mutans and Streptococcus dentisani, and plaque samples of quadrants 2 and 4 by the vestibular and lingual surfaces to quantify the lactic acid produced by the ex vivo plaque, and its pH. The pH of the saliva will also be evaluated before and after brushing with only water and then measured before and after a rinse with active movements with 10 ml of a 10% sugar solution for 1 minute. Finally, the buffering capacity of the saliva, measured by the amount of acid that the saliva is capable of buffering using reactive strips, will be evaluated.
The participants will be treated with probiotic or placebo, depending on the group to which they have been assigned, without the participant or the researcher knowing the assigned treatment. For this the two products will present the same appearance. The randomization will remain blind until the end of the study.
The treatment will consist of the application of the product in the form of gel by all the free surfaces of the teeth by means of a splint. The production of the splints will be done by the same recruiting center. These are washable and reusable splints during the entire study treatment.
The first treatment will be carried out during the baseline visit and will be applied by the clinic professional, who will explain to the participant how to perform successive applications at home every 48 hours.
Participants will receive the splint and the exact number of doses of probiotic or placebo needed for the next visit, which they should return in a bag to verify that the treatment has been followed correctly. Likewise, volunteers will receive a fluoride toothpaste (1000 ppm), a toothbrush and instructions on how to maintain healthy hygiene habits to standardize study conditions. The use of mouthwashes and oral probiotic consumption will be expressly prohibited during the study, all participants will receive a copy of Annexes I and II with the list of mouthwash and probiotic products not admitted.
Visit 1 (Day 15 ± 2 days, follow-up visit):
In this visit participants will be asked to deliver the unused material and they will be provided with the treatments in the exact dosage number until the next visit, as well as the elements for oral hygiene. The appearance of any adverse effect during the consumption of the product will be reviewed with the patient, for it a dental revision will be carried out to evaluate different parameters (plaque index, gingival index and salivary flow among others). During this visit, samples of saliva (2 ml) and plaque (from quadrants 1 and 3 on the vestibular and lingual surfaces) will be taken for the quantification and detection of S. mutans and Streptococcus dentisani, and plaque samples of quadrants 2 and 4 by the vestibular and lingual surfaces to quantify the lactic acid produced by the ex vivo plaque, and its pH. The pH of the saliva will also be evaluated before and after brushing with only water and then measured before and after a rinse with active movements with 10 ml of a 10% sugar solution for 1 minute. Finally, the buffer capacity of saliva will be evaluated.
During this visit, the clinic professional will once again apply the product to all participants and remind them how successive applications should be made at their home every 48 hours.
Visit 2 (Day 30 ± 2 days, end of treatment):
The same procedure will be followed as in visit 1 (day 15), but new single doses will not be provided.
Visit 3 (Day 45 ± 2 days, final visit):
During this visit, samples of saliva (2 ml) and plaque (from quadrants 1 and 3 on the vestibular and lingual surfaces) will be taken for the quantification and detection of S. mutans and Streptococcus dentisani, and plaque samples of quadrants 2 and 4 by the vestibular and lingual surfaces to quantify the lactic acid produced by the ex vivo plaque, and its pH. The pH of the saliva will also be evaluated before and after brushing with only water and then measured before and after a rinse with active movements with 10 ml of a 10% sugar solution for 1 minute. Finally, the buffer capacity of saliva will be evaluated.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProbioticBiological
Already described
PlaceboBiological
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Composition: excipients without probiotic: 2%w/v Guam guar and 6% w/v hydroxyethilcellulose Application in mouth of a bucoadhesive gel. Applied by the profesional at days 0, 15 and 30 and by the participants the rest of the days Frequency: each 48 h by the participants Duration: during 30 days Receives: Biological: Placebo |
| Probiotic | Active comparator | Composition: Streptococcus dentisani: 2,5E+09CFUs, 2% (p/v) Guam Guar and 6% (p/v) Hidroxietilcelulosa. Dose of 2.5E+09 cfu/vial considering one administration every 48 hours, it will be equivalent to a dose of 1.0E+10 cfu/week Application in mouth of a bucoadhesive gel. Applied by the profesional at days 0, 15 and 30 and by the participants the rest of the days Frequency: each 48 h by the participants Duration: during 30 days Receives: Biological: Probiotic |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline Salivary pH before and after brushing with wáter at 15, 30 and 45 days
Increase in salivary pH measured on the RQflex 10 reflectometer using Reflectoquant test strips at 15, 30 and 45 days visit compared with basal value
Measured: Through study completion, an average of 9 months
Adverse effects
Any adverse effect (symptom, illness or other event of medical relevance) experienced by the participant during the course of the study or detected by the physician will be recorded in the data collection notebook, regardless of whether its nature may or may not be associated with the product in study. The registry of adverse effects will detail the nature of the adverse effect, its severity, the time of appearance and duration, the actions necessary for its treatment (if necessary) and the potential relationship with the treatment of the study, as well as any other relevant information .
Measured: Through study completion, an average of 9 months
Secondary outcomes (8)
Concentration of S. mutans
Concentration of S. mutans analysed by qPCR obtained from saliva and plaque samples at days 15, 30 and 45 compared with basal value
Measured: Through study completion, an average of 9 months
Concentration of S. dentisani
Concentration of S. dentisani analysed by qPCR obtained from saliva and plaque samples at days 15, 30 and 45 compared with basal value
Measured: Through study completion, an average of 9 months
Lactic acid quantification before and after a sugar shock
Quantification of lactic acid of the plaque ex vivo before and after a sugar shock measured in the RQflex 10 reflectometer by using Reflectoquant strips for lactate at days 15, 30 and 45 compared with basal value
Measured: Through study completion, an average of 9 months
pH quantification before and after a sugar shock
Quantification of pH of the plaque ex vivo before and after a sugar shock measured in the RQflex 10 reflectometer by using Reflectoquant strips for pH at days 15, 30 and 45 compared with basal value
Measured: Through study completion, an average of 9 months
Salivary pH before and after a sugar shock
Increase in salivary pH measured on the RQflex 10 reflectometer using Reflectoquant test strips at 15, 30 and 45 days visit compared with basal value after a sugar shock consisting in rinsing and active movements for 1 minute of a sterile 10% glucose solution.
Measured: Through study completion, an average of 9 months
Caries
Occurrence of caries at 15, 30 and 45 days visit compared with basal value
Measured: Through study completion, an average of 9 months
Plaque
Decrease in plaque index at 15, 30 and 45 days visit compared with basal value
Measured: Through study completion, an average of 9 months
Buffer capacity of the saliva
Buffer capacity of the saliva measured by reactive strips, which determine the amount of acid that the saliva is capable of neutralizing at 15, 30 and 45 days visit compared with basal value
Measured: Through study completion, an average of 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2018
- Study start13 May 2016
- Primary completion24 Mar 2017
- Study completion20 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CariesStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study will follow a randomized, double-blind, placebo-controlled design with 2 parallel prospective follow-up groups.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- AB Biotics, SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana
- Responsible party
- Sponsor
- Investigators
- Enrique Conde, Study director, Effice
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03468842
- Sponsor's protocol ID
- ABB-DENTISANI-2015
- Status last verified
- Feb 2018
- First submitted
- 26 Feb 2018
- Last updated
- 19 Mar 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Double-blind, Placebo-controlled Parallel Group Study to Evaluate the Clinical Efficacy of Streptococcus Dentisani CECT 7746 in Caries Risk Reduction
- ClinicalTrials.gov ID
- NCT03468842
- Acronym / sponsor ID
- ABB-DENTISANI-2015
- Conditions
- Caries
- Keywords
- Streptococcus dentisani, caries, salivary pH, S. mutans
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- AB Biotics, SAIndustry (pharma, biotech, devices)
- Collaborators
- Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana
- Study start
- 13 May 2016 (actual)
- Primary completion
- 24 Mar 2017 (actual)
- Study completion
- 20 Dec 2017 (actual)
- First posted
- 19 Mar 2018 (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.
Exploratory, phase I study to evaluate the clinical efficacy of Streptococcus dentisani CECT 7746 in the risk reduction of caries. Patients who meet the inclusion and exclusion criteria will be randomized and receive the corresponding treatment. The study will follow a randomized design, with two groups in parallel (placebo group and probiotic group) of prospective, double-blind follow-up, for a period of 45 days. The present study will be conducted in a single center and will include a total of 70 patients. The present study has a double main objective:
- Evaluate whether the administration of the probiotic S. dentisani CECT 7746 alkalizes the basal pH of saliva.
- Test the safety and tolerability of the probiotic
Secondary
- Evaluate other microbiological parameters associated with caries risk such as the presence of microorganisms such as S. mutans.
- Evaluate the presence in the mouth and colonization capacity of S. dentisani.
- Evaluate the lactic acid and the pH of the ex vivo plate before and after the administration of a sugar solution
- Evaluate the salivary pH before and after the administration of a sugar solution
- Evaluate the salivary pH before brushing with water.
- Evaluate the buffer capacity of saliva
Detailed description
The probiotic Streptococcus dentisani is a bacterial species present in the human oral microbial flora. It was isolated initially, as result of observation and hypothesis, of volunteers who had never developed caries. These strains have demonstrated, through in vitro studies, an enormous potential of inhibition against S. mutans, besides inhibiting the growth of other pathogens commonly present in common oral pathologies (gingivitis, periodontitis or halitosis). The probiotic product has been shown to be effective in in vitro experiments, artificial mouth models and epidemiological data, statistically significant. However, it is necessary to document the efficacy of Streptococcus dentisani in an oral application study.
Recruitment visit:
In a first visit, it will be assessed if the candidates meet all the inclusion criteria and none of the exclusion criteria. For this, a dental revision will be carried out to assess the different parameters (plaque index, gingival index and salivary flow among others), and a saliva sample will be taken after brushing with water to determine its basal pH.
Those participants who meet the criteria and provide written informed consent will be assigned to one of the two treatment groups (probiotic or placebo). The assignment will be done randomly using a computer generated list.
In this first visit, an impression of the jaw will also be made of those volunteers who meet the criteria and have been randomized. This impression will be used to manufacture custom splints that allow a more comfortable application of the treatment during the study by the participants.
A detailed list of probiotic products present in the market for oral use will be provided.
Basal visit (Day 0):
After 1-2 weeks of the recruitment visit, participants will return to the center for the baseline visit. During this visit, samples of saliva (2 ml) and plaque (from quadrants 1 and 3 on the vestibular and lingual surfaces) will be taken for the quantification and detection of S. mutans and Streptococcus dentisani, and plaque samples of quadrants 2 and 4 by the vestibular and lingual surfaces to quantify the lactic acid produced by the ex vivo plaque, and its pH. The pH of the saliva will also be evaluated before and after brushing with only water and then measured before and after a rinse with active movements with 10 ml of a 10% sugar solution for 1 minute. Finally, the buffering capacity of the saliva, measured by the amount of acid that the saliva is capable of buffering using reactive strips, will be evaluated.
The participants will be treated with probiotic or placebo, depending on the group to which they have been assigned, without the participant or the researcher knowing the assigned treatment. For this the two products will present the same appearance. The randomization will remain blind until the end of the study.
The treatment will consist of the application of the product in the form of gel by all the free surfaces of the teeth by means of a splint. The production of the splints will be done by the same recruiting center. These are washable and reusable splints during the entire study treatment.
The first treatment will be carried out during the baseline visit and will be applied by the clinic professional, who will explain to the participant how to perform successive applications at home every 48 hours.
Participants will receive the splint and the exact number of doses of probiotic or placebo needed for the next visit, which they should return in a bag to verify that the treatment has been followed correctly. Likewise, volunteers will receive a fluoride toothpaste (1000 ppm), a toothbrush and instructions on how to maintain healthy hygiene habits to standardize study conditions. The use of mouthwashes and oral probiotic consumption will be expressly prohibited during the study, all participants will receive a copy of Annexes I and II with the list of mouthwash and probiotic products not admitted.
Visit 1 (Day 15 ± 2 days, follow-up visit):
In this visit participants will be asked to deliver the unused material and they will be provided with the treatments in the exact dosage number until the next visit, as well as the elements for oral hygiene. The appearance of any adverse effect during the consumption of the product will be reviewed with the patient, for it a dental revision will be carried out to evaluate different parameters (plaque index, gingival index and salivary flow among others). During this visit, samples of saliva (2 ml) and plaque (from quadrants 1 and 3 on the vestibular and lingual surfaces) will be taken for the quantification and detection of S. mutans and Streptococcus dentisani, and plaque samples of quadrants 2 and 4 by the vestibular and lingual surfaces to quantify the lactic acid produced by the ex vivo plaque, and its pH. The pH of the saliva will also be evaluated before and after brushing with only water and then measured before and after a rinse with active movements with 10 ml of a 10% sugar solution for 1 minute. Finally, the buffer capacity of saliva will be evaluated.
During this visit, the clinic professional will once again apply the product to all participants and remind them how successive applications should be made at their home every 48 hours.
Visit 2 (Day 30 ± 2 days, end of treatment):
The same procedure will be followed as in visit 1 (day 15), but new single doses will not be provided.
Visit 3 (Day 45 ± 2 days, final visit):
During this visit, samples of saliva (2 ml) and plaque (from quadrants 1 and 3 on the vestibular and lingual surfaces) will be taken for the quantification and detection of S. mutans and Streptococcus dentisani, and plaque samples of quadrants 2 and 4 by the vestibular and lingual surfaces to quantify the lactic acid produced by the ex vivo plaque, and its pH. The pH of the saliva will also be evaluated before and after brushing with only water and then measured before and after a rinse with active movements with 10 ml of a 10% sugar solution for 1 minute. Finally, the buffer capacity of saliva will be evaluated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- The study will follow a randomized, double-blind, placebo-controlled design with 2 parallel prospective follow-up groups.
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Biological: PlaceboComposition: excipients without probiotic: 2%w/v Guam guar and 6% w/v hydroxyethilcellulose Application in mouth of a bucoadhesive gel. Applied by the profesional at days 0, 15 and 30 and by the participants the rest of the days Frequency: each 48 h by the participants Duration: during 30 days |
| Probiotic | Active comparator | Biological: ProbioticComposition: Streptococcus dentisani: 2,5E+09CFUs, 2% (p/v) Guam Guar and 6% (p/v) Hidroxietilcelulosa. Dose of 2.5E+09 cfu/vial considering one administration every 48 hours, it will be equivalent to a dose of 1.0E+10 cfu/week Application in mouth of a bucoadhesive gel. Applied by the profesional at days 0, 15 and 30 and by the participants the rest of the days Frequency: each 48 h by the participants Duration: during 30 days |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Men and women between the ages of 18 and 65
- With a previous history of caries and / or active cavities
- Absence of other oral diseases
- With a basal oral pH (after brushing with only water) in saliva equal to or less than 7
Key exclusion criteria (7 listed)
- Antibiotic use during the 30 days prior to the start of the study.
- Usual consumption of chlorhexidine or other mouthwashes with bactericidal active ingredients during the 30 days prior to the start of the study.
- Consumption of oral probiotics during the 30 days prior to the start of the study (Annex II)
- Pregnant or lactating women
- Participants with chronic diseases (eg diabetes, kidney problems, cancer) or who may affect the salivary flow
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 |
|---|---|---|
| ProbioticAlready described | Biological | Probiotic |
| PlaceboPlacebo | Biological | Placebo |
Primary outcome
Change from baseline Salivary pH before and after brushing with wáter at 15, 30 and 45 days
Time frame: Through study completion, an average of 9 months
Increase in salivary pH measured on the RQflex 10 reflectometer using Reflectoquant test strips at 15, 30 and 45 days visit compared with basal value
Adverse effects
Time frame: Through study completion, an average of 9 months
Any adverse effect (symptom, illness or other event of medical relevance) experienced by the participant during the course of the study or detected by the physician will be recorded in the data collection notebook, regardless of whether its nature may or may not be associated with the product in study. The registry of adverse effects will detail the nature of the adverse effect, its severity, the time of appearance and duration, the actions necessary for its treatment (if necessary) and the potential relationship with the treatment of the study, as well as any other relevant information .
8 secondary outcomes
Concentration of S. mutans
Time frame: Through study completion, an average of 9 months
Concentration of S. dentisani
Time frame: Through study completion, an average of 9 months
Lactic acid quantification before and after a sugar shock
Time frame: Through study completion, an average of 9 months
pH quantification before and after a sugar shock
Time frame: Through study completion, an average of 9 months
Salivary pH before and after a sugar shock
Time frame: Through study completion, an average of 9 months
Caries
Time frame: Through study completion, an average of 9 months
Plaque
Time frame: Through study completion, an average of 9 months
Buffer capacity of the saliva
Time frame: Through study completion, an average of 9 months
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 19 Mar 2018.
- 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.
Enrique Conde study director
Effice
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Probiotic in people with Caries, run by AB Biotics, SA at 1 site in Spain.
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 19 Mar 2018. 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 Spain. 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. Some participants in this study may receive a placebo. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Change from baseline Salivary pH before and after brushing with wáter at 15, 30 and 45 days (time frame: Through study completion, an average of 9 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Mar 2018.