Oral HealthNCT03522363
Streptococcus Dentisani Colonization Capacity in a Split Mouth Model
A study testing Streptococcus dentisani CECT7746 in people with Oral Health, run by AB Biotics, SA at 1 site in Spain.
Trial summary
Pilot study with healthy subjects to test the in vivo potential colonization ability of S. dentisani. Phase I, exploratory, prospective, mechanistic pilot clinical trial with two parallel follow-up groups. Probiotic will be applied topically as an adhesive gel with a dental splint under different dosing regimes. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Oral Health
- What is being tested?
- Streptococcus dentisani CECT7746
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteSpain
- Study dates
- 5 Feb 2016to 20 Sep 2016
- Phase
- Interventional
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Absence of serious periodontal diseases (eg gingivitis, periodontitis)
- Ability to understand the requirements and implications of the study
Who cannot join
- Antibiotic consumption during the 30 days prior to the initiation of the study.
- Oral probiotics consumption during the 30 days before the start of the study
- Pregnant or lactating women
- Chronic diseases (eg, diabetes, kidney problems, cancer) or diseases that could affect salivary flow.
- Chronic treatment or medication that could reduce salivary flow, such as antidepressants or psychotropic drugs.
- Allergy to any of the product composition ingredients
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: Study of Streptococcus Dentisani Capacity to Colonize Supragingival Plaque in a Split Mouth Model
Pilot study with healthy subjects to test the in vivo potential colonization ability of S. dentisani. Phase I, exploratory, prospective, mechanistic pilot clinical trial with two parallel follow-up groups. Probiotic will be applied topically as an adhesive gel with a dental splint under different dosing regimes. Saliva and plaque samples will be obtained at day 0, 14 and 28.
Read the detailed description
Phase I study, exploratory, prospective, mechanistic, to evaluate the capacity of
Streptococcus dentisani CECT 7746 of colonizing the tooth surface. The study will be carried out with 10 healthy subjects divided into two groups (n = 5 per group) that differ in the number of applications of probiotic:
Group A: participants who will receive a single application of the product during the initial visit Group B: participants who will receive 7 applications on consecutive days, with the first in the start visit. Probiotic will be applied topically as an adhesive gel with a dental splint under different dosing regimes.The total dose received will be the same for both groups, and the total duration of the follow-up will be of 4 weeks from the first application also for both groups.
On day 0: Participants who meet the inclusion and exclusion criteria will be randomized in one of the two groups. Saliva and plaque samples will be obtained by the dentist, and all the participants will receive an professional teeth cleaning in one half of the mouth (quadrants 1-4). Afterwads, treatment will be applied by the dentist according to assigned group, and the randomized participants in the multiple-dose group will be explained how to perform the six successive applications at home every 24 hours.
On day 14: follow-up visit, saliva and plaque samples will be obtained from all participants. Patient assigned to the multi-dose group will return the used material On day 28th: final visit, saliva and plaque samples will be obtained.
- Conditions
- Oral Health
- Being tested
- Streptococcus dentisani CECT7746
- Keywords
- oral health, Streptococcus dentisani
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Streptococcus dentisani CECT7746Other
Treatment will be applied topically as an adhesive gel with a dental splint
| Study group | Role | What they receive |
|---|---|---|
| Monodose group | Experimental | 1 vial with 4E10 CFU/g Total dose treatment: 4E10 CFU Receives: Other: Streptococcus dentisani CECT7746 |
| Multidose group | Experimental | 7 vials with 5,5E09 CFU/g Total dose treatment: 4E10 CFU Receives: Other: Streptococcus dentisani CECT7746 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Streptococcus dentisani CECT 7746 colonization capacity
Demonstrate the ability of Streptococcus dentisani CECT 7746 to adhere, colonize and remain in the dental surface after its application, with or without previous professional oral cleaning
Measured: A measure to see the change in the Baseline Streptococcus dentisani adherence will be made in V1 and V2 (14 days and 28 days after the treatment beginning, respectivetly)
Secondary outcomes (2)
Streptococcus mutans concentration
To evaluate if the administration of the probiotic S. dentisani CECT 7746 reduces the amount of oral Streptococcus mutans.
Measured: 0 - 14- 28 days
Oral acid production
To evaluate if the administration of the S. dentisani CECT 7746 reduces the amount of acid produced after an oral sugar solution administration
Measured: 0 - 14- 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2018
- Study start5 Feb 2016
- Primary completion11 Mar 2016
- Study completion20 Sep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Phase I, exploratory, prospective, mechanistic pilot clinical trial with two parallel follow-up groups that differ in the number of treament applications.
- Masking
- None (open label)
- Enrolment
- 11 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
- Alex Mira, Dr., Principal investigator, Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03522363
- Sponsor's protocol ID
- ABB-Sdentcolonization
- Status last verified
- Feb 2018
- First submitted
- 9 Feb 2018
- Last updated
- 11 May 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Streptococcus Dentisani Capacity to Colonize Supragingival Plaque in a Split Mouth Model
- ClinicalTrials.gov ID
- NCT03522363
- Acronym / sponsor ID
- ABB-Sdentcolonization
- Conditions
- Oral Health
- Keywords
- oral health, Streptococcus dentisani
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 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
- 5 Feb 2016 (actual)
- Primary completion
- 11 Mar 2016 (actual)
- Study completion
- 20 Sep 2016 (actual)
- First posted
- 11 May 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.
Pilot study with healthy subjects to test the in vivo potential colonization ability of S. dentisani. Phase I, exploratory, prospective, mechanistic pilot clinical trial with two parallel follow-up groups. Probiotic will be applied topically as an adhesive gel with a dental splint under different dosing regimes. Saliva and plaque samples will be obtained at day 0, 14 and 28.
Detailed description
Phase I study, exploratory, prospective, mechanistic, to evaluate the capacity of
Streptococcus dentisani CECT 7746 of colonizing the tooth surface. The study will be carried out with 10 healthy subjects divided into two groups (n = 5 per group) that differ in the number of applications of probiotic:
Group A: participants who will receive a single application of the product during the initial visit Group B: participants who will receive 7 applications on consecutive days, with the first in the start visit. Probiotic will be applied topically as an adhesive gel with a dental splint under different dosing regimes.The total dose received will be the same for both groups, and the total duration of the follow-up will be of 4 weeks from the first application also for both groups.
On day 0: Participants who meet the inclusion and exclusion criteria will be randomized in one of the two groups. Saliva and plaque samples will be obtained by the dentist, and all the participants will receive an professional teeth cleaning in one half of the mouth (quadrants 1-4). Afterwads, treatment will be applied by the dentist according to assigned group, and the randomized participants in the multiple-dose group will be explained how to perform the six successive applications at home every 24 hours.
On day 14: follow-up visit, saliva and plaque samples will be obtained from all participants. Patient assigned to the multi-dose group will return the used material On day 28th: final visit, saliva and plaque samples will be obtained.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Phase I, exploratory, prospective, mechanistic pilot clinical trial with two parallel follow-up groups that differ in the number of treament applications.
| Arm | Type | Receives |
|---|---|---|
| Monodose group | Experimental | Other: Streptococcus dentisani CECT77461 vial with 4E10 CFU/g Total dose treatment: 4E10 CFU |
| Multidose group | Experimental | Other: Streptococcus dentisani CECT77467 vials with 5,5E09 CFU/g Total dose treatment: 4E10 CFU |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Absence of serious periodontal diseases (eg gingivitis, periodontitis)
- Ability to understand the requirements and implications of the study
Key exclusion criteria (6 listed)
- Antibiotic consumption during the 30 days prior to the initiation of the study.
- Oral probiotics consumption during the 30 days before the start of the study
- Pregnant or lactating women
- Chronic diseases (eg, diabetes, kidney problems, cancer) or diseases that could affect salivary flow.
- Chronic treatment or medication that could reduce salivary flow, such as antidepressants or psychotropic drugs.
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 |
|---|---|---|
| Streptococcus dentisani CECT7746Treatment will be applied topically as an adhesive gel with a dental splint | Other | Monodose group, Multidose group |
Primary outcome
Streptococcus dentisani CECT 7746 colonization capacity
Time frame: A measure to see the change in the Baseline Streptococcus dentisani adherence will be made in V1 and V2 (14 days and 28 days after the treatment beginning, respectivetly)
Demonstrate the ability of Streptococcus dentisani CECT 7746 to adhere, colonize and remain in the dental surface after its application, with or without previous professional oral cleaning
2 secondary outcomes
Streptococcus mutans concentration
Time frame: 0 - 14- 28 days
Oral acid production
Time frame: 0 - 14- 28 days
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 11 May 2018.
- Individual participant dataSharing planned: Undecided
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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.
Alex Mira, Dr. principal investigator
Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Streptococcus dentisani CECT7746 in people with Oral Health, 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 2 inclusion and 6 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 11 May 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
Streptococcus dentisani CECT 7746 colonization capacity (time frame: A measure to see the change in the Baseline Streptococcus dentisani adherence will be made in V1 and V2 (14 days and 28 days after the treatment beginning, respectivetly)). 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 11 May 2018.