Periodontal DiseaseAB-GUM-2016NCT03540498
Study of Colonization of Strains L.Plantarum and L.Brevis in the Product AB-DENTALAC Chewing Gum
A study testing AB-DENTALAC [Probiotics (study)] in people with Periodontal Disease, run by AB Biotics, SA.
Trial summary
Study will follow a randomized, double-blind, placebo-controlled design with two groups in parallel,N of 40 patients in 6 weeks of follow up for the evaluation of two different posology models (daily consumption of probiotic gum, with or without previous professional oral cleaning). Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Periodontal Disease
- What is being tested?
- AB-DENTALAC [Probiotics (study)]
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 13 Oct 2016to 27 Feb 2017
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Women and men between 18-55 years.
- Capacity to understand the procedures and implications of the study.
- Gingival Index <1,5 (Löe and Silness, Acta Odontol Scand. 1963. 21:533-51)
- Plaque Index <2,0 (Löe and Silness, Acta Odontol Scand. 1963. 21:533-51)
- Periodontal pocket depth <5 mm
Who cannot join
- Less than 20 natural teeth
- More than 2 untreated caries at the time of enrollment
- Current orthodontic or periodontal treatment
- Hypersensitivity or allergy to any of the ingredients of the experimental product
- Consumption of antibiotics in the 8 weeks prior to treatment
- Use of probiotics designed to improve oral health, or having consumed them during the 8 weeks prior to the study
Show all 10Show fewer
- Consumption of any type of probiotic during the 4 weeks prior to the study
- Usual consumption of clorhexidine or other mouthwashes with bactericidal active ingredients during the 30 days before the start of the study
- Pregnant or lactating women
- Participants with chronic diseases (eg, diabetes, kidney problems, cancer) or under chronic treatment
About this study
Official title: Oral Colonization by Lactobacillus Brevis KABP 052 (CECT 7480) and Lactobacillus Plantarum KABP 051 (CECT 7481): A Randomized, Double-Blinded, Placebo-Controlled Trial
Study will follow a randomized, double-blind, placebo-controlled design with two groups in parallel,N of 40 patients in 6 weeks of follow up for the evaluation of two different posology models (daily consumption of probiotic gum, with or without previous professional oral cleaning). Probiotics have recently been used to combat oral diseases (plaque control, caries, halitosis, etc.), as a non-invasive natural therapy.
Read the detailed description
The study will follow a randomized, double-blind, placebo-controlled design with two groups in parallel, for the evaluation of two different posology models (daily consumption of probiotic gum, with or without previous professional oral cleaning). Probiotics have recently been used to combat oral diseases (plaque control, caries, halitosis, etc.), as a non-invasive natural therapy.
The aim of this study is to assess whether the daily consumption of AB-DENTALAC gum allows the colonization of strains L.plantarum KABP051 (CECT7481) and L.brevis KABP052 (CECT7480) in the oral microbiota, and to confirm the absence of side effects, with the following setup:
- Number of patients to be randomized:40
- Number of visits per patient: 2
The study will determine the index of plaque and gingival index as a measure of oral health. The presence of Lactobacillus in the samples collected by qPCR will also be quantified.
The patient will benefit from a buccal revision and control by a periodontist for 6 weeks. It will also help subsequent patients to obtain a better treatment (if the results are significant). No harm is expected to participate, it is a minimal risk study, with non-invasive exploratory tests and a product suitable for human consumption and marketed in Europe since 2012.
The potential patients to participate in the study will be healthy patients, so if they do not wish to participate they will not need alternative treatment. The objective of the study is to see if the probiotic is able to colonize the mouth in healthy patients, it is not a study to demonstrate the effectiveness of the product.
If there is any serious adverse effect (something totally unexpected being a product with probiotic strains QPS), the patient will be advised to stop taking the product immediately. It is not anticipated that the use of any additional treatment is necessary.
The promoter will provide all the necessary material for the study: 60 cases of placebo chewing gum, 60 cases of probiotic chewing gum, and cleaning material (toothbrush and fluoridated toothpaste) for all patients.
Statistical analysis of bacterial colonization will be performed using Student's T with logarithmic transformation of data if required, considering a two-tailed P <0.05 as significance cut-off.
- Conditions
- Periodontal Disease
- Being tested
- AB-DENTALAC [Probiotics (study)], Placebo (control)
- Keywords
- Oral health, Probiotics, L. plantarum, L. brevis, Periodontics, Dental plaque
- Medical subject headings
- Periodontal Diseases, Dental Plaque
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AB-DENTALAC [Probiotics (study)]Dietary supplement
Treatment for 6 weeks, which will consist of the consumption of a chewing gum AB-DENTALAC with 100mg L.plantarum + L.brevis Probiotics blend (5E+8 CFU each at the end of shelf life), b.i.d (morning and evening).
Placebo (control)Dietary supplement
Treatment for 6 weeks, which will consist of the consumption of a chewing gum placebo, without probiotics strains, b.i.d (morning and evening).
| Study group | Role | What they receive |
|---|---|---|
| Probiotics | Experimental | The volunteers will follow the assigned treatment for 6 weeks (PROBIOTICS_AB-DENTALAC CHEWING GUM. Orally) , which will consist of the consumption of 2 chewing gums a day. The chewing gum should be chewed for at least 15-20 minutes at least 1 hour after the consumption of food. For at least 1 hour after the consumption of chewing gum, volunteers will not be able to consume food, drink (except water) or clean their teeth. Adherence to the treatment will be made by returning the empty containers after 6 weeks. Receives: Dietary Supplement: AB-DENTALAC [Probiotics (study)] |
| Control | Placebo comparator | The volunteers will follow the assigned treatment for 6 weeks (PLACEBOS CHEWING GUM. Orally) , which will consist of the consumption of 2 chewing gums a day. The chewing gum should be chewed for at least 15-20 minutes at least 1 hour after the consumption of food. For at least 1 hour after the consumption of chewing gum, volunteers will not be able to consume food, drink (except water) or clean their teeth. Adherence to the treatment will be made by returning the empty containers. Receives: Dietary Supplement: Placebo (control) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Probiotic colonization of the oral cavity (qPCR)
Quantification of L. brevis and L. plantarum by species-specific qPCR in pooled samples of saliva, dental plaque (from the CPI subset) and lingual plaque
Measured: Change from Baseline assessed 6 weeks after study entry
Secondary outcomes (2)
Progression of PII
Plaque Index (PlI; Silness and Löe 1964) in the CPI teeth subset, as recorded at the first visit and at the end of the study by the dentist.
Measured: Change from Baseline assessed 6 weeks after study entry
Progression of GI
Gingival Index (GI; Löe and Silness 1963) in the CPI teeth subset, as recorded at the first visit and at the end of the study by the dentist.
Measured: Change from Baseline assessed 6 weeks after study entry
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2018
- Study start13 Oct 2016
- Primary completion24 Nov 2016
- Study completion27 Feb 2017
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 Periodontal DiseaseStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study will follow a randomized, double-blind, split-mouth, placebo-controlled design with two parallel prospective follow-up groups for the evaluation of two different posology models (with or without previous professional oral cleaning).
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- AB Biotics, SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Clínica Odontológica Nart en Barcelona
- Responsible party
- Sponsor
- Investigators
- Jordi Espadaler Mazo, PhD, Study chair, AB Biotics, SAJose Nart Molina, DMD, Principal investigator, Clínica Odontológica Nart en Barcelona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03540498
- Sponsor's protocol ID
- AB-GUM-2016
- Acronym
- AB-GUM-2016
- Status last verified
- Dec 2019
- First submitted
- 7 May 2018
- Last updated
- 18 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Nart J, Jimenez-Garrido S, Ramirez-Sebastia A, Asto E, Buj D, Huedo P, Espadaler J. Oral colonization by Levilactobacillus brevis KABPTM-052 and Lactiplantibacillus plantarum KABPTM-051: A Randomized, Double-Blinded, Placebo-Controlled Trial (Pilot Study). J Clin Exp Dent. 2021 May 1;13(5):e433-e439. doi: 10.4317/jced.57771. eCollection 2021 May.
PubMed 33981389
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oral Colonization by Lactobacillus Brevis KABP 052 (CECT 7480) and Lactobacillus Plantarum KABP 051 (CECT 7481): A Randomized, Double-Blinded, Placebo-Controlled Trial
- ClinicalTrials.gov ID
- NCT03540498
- Acronym / sponsor ID
- AB-GUM-2016 / AB-GUM-2016
- Conditions
- Periodontal Disease
- Keywords
- Oral health, Probiotics, L. plantarum, L. brevis, Periodontics, Dental plaque
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- AB Biotics, SAIndustry (pharma, biotech, devices)
- Collaborators
- Clínica Odontológica Nart en Barcelona
- Study start
- 13 Oct 2016 (actual)
- Primary completion
- 24 Nov 2016 (actual)
- Study completion
- 27 Feb 2017 (actual)
- First posted
- 30 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.
Study will follow a randomized, double-blind, placebo-controlled design with two groups in parallel,N of 40 patients in 6 weeks of follow up for the evaluation of two different posology models (daily consumption of probiotic gum, with or without previous professional oral cleaning). Probiotics have recently been used to combat oral diseases (plaque control, caries, halitosis, etc.), as a non-invasive natural therapy.
Detailed description
The study will follow a randomized, double-blind, placebo-controlled design with two groups in parallel, for the evaluation of two different posology models (daily consumption of probiotic gum, with or without previous professional oral cleaning). Probiotics have recently been used to combat oral diseases (plaque control, caries, halitosis, etc.), as a non-invasive natural therapy.
The aim of this study is to assess whether the daily consumption of AB-DENTALAC gum allows the colonization of strains L.plantarum KABP051 (CECT7481) and L.brevis KABP052 (CECT7480) in the oral microbiota, and to confirm the absence of side effects, with the following setup:
- Number of patients to be randomized:40
- Number of visits per patient: 2
The study will determine the index of plaque and gingival index as a measure of oral health. The presence of Lactobacillus in the samples collected by qPCR will also be quantified.
The patient will benefit from a buccal revision and control by a periodontist for 6 weeks. It will also help subsequent patients to obtain a better treatment (if the results are significant). No harm is expected to participate, it is a minimal risk study, with non-invasive exploratory tests and a product suitable for human consumption and marketed in Europe since 2012.
The potential patients to participate in the study will be healthy patients, so if they do not wish to participate they will not need alternative treatment. The objective of the study is to see if the probiotic is able to colonize the mouth in healthy patients, it is not a study to demonstrate the effectiveness of the product.
If there is any serious adverse effect (something totally unexpected being a product with probiotic strains QPS), the patient will be advised to stop taking the product immediately. It is not anticipated that the use of any additional treatment is necessary.
The promoter will provide all the necessary material for the study: 60 cases of placebo chewing gum, 60 cases of probiotic chewing gum, and cleaning material (toothbrush and fluoridated toothpaste) for all patients.
Statistical analysis of bacterial colonization will be performed using Student's T with logarithmic transformation of data if required, considering a two-tailed P <0.05 as significance cut-off.
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, split-mouth, placebo-controlled design with two parallel prospective follow-up groups for the evaluation of two different posology models (with or without previous professional oral cleaning).
| Arm | Type | Receives |
|---|---|---|
| Probiotics | Experimental | Dietary Supplement: AB-DENTALAC [Probiotics (study)]The volunteers will follow the assigned treatment for 6 weeks (PROBIOTICS_AB-DENTALAC CHEWING GUM. Orally) , which will consist of the consumption of 2 chewing gums a day. The chewing gum should be chewed for at least 15-20 minutes at least 1 hour after the consumption of food. For at least 1 hour after the consumption of chewing gum, volunteers will not be able to consume food, drink (except water) or clean their teeth. Adherence to the treatment will be made by returning the empty containers after 6 weeks. |
| Control | Placebo comparator | Dietary Supplement: Placebo (control)The volunteers will follow the assigned treatment for 6 weeks (PLACEBOS CHEWING GUM. Orally) , which will consist of the consumption of 2 chewing gums a day. The chewing gum should be chewed for at least 15-20 minutes at least 1 hour after the consumption of food. For at least 1 hour after the consumption of chewing gum, volunteers will not be able to consume food, drink (except water) or clean their teeth. Adherence to the treatment will be made by returning the empty containers. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Women and men between 18-55 years.
- Capacity to understand the procedures and implications of the study.
- Gingival Index <1,5 (Löe and Silness, Acta Odontol Scand. 1963. 21:533-51)
- Plaque Index <2,0 (Löe and Silness, Acta Odontol Scand. 1963. 21:533-51)
- Periodontal pocket depth <5 mm
Key exclusion criteria (10 listed)
- Less than 20 natural teeth
- More than 2 untreated caries at the time of enrollment
- Current orthodontic or periodontal treatment
- Hypersensitivity or allergy to any of the ingredients of the experimental product
- Consumption of antibiotics in the 8 weeks prior to treatment
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 |
|---|---|---|
| AB-DENTALAC [Probiotics (study)]Treatment for 6 weeks, which will consist of the consumption of a chewing gum AB-DENTALAC with 100mg L.plantarum + L.brevis Probiotics blend (5E+8 CFU each at the end of shelf life), b.i.d (morning and evening). | Dietary supplement | Probiotics |
| Placebo (control)Treatment for 6 weeks, which will consist of the consumption of a chewing gum placebo, without probiotics strains, b.i.d (morning and evening). | Dietary supplement | Control |
Primary outcome
Probiotic colonization of the oral cavity (qPCR)
Time frame: Change from Baseline assessed 6 weeks after study entry
Quantification of L. brevis and L. plantarum by species-specific qPCR in pooled samples of saliva, dental plaque (from the CPI subset) and lingual plaque
2 secondary outcomes
Progression of PII
Time frame: Change from Baseline assessed 6 weeks after study entry
Progression of GI
Time frame: Change from Baseline assessed 6 weeks after study entry
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 18 Dec 2019.
- Derived from this study: PubMed 33981389Nart J, Jimenez-Garrido S, Ramirez-Sebastia A, Asto E, Buj D, Huedo P, Espadaler J. Oral colonization by Levilactobacillus brevis KABPTM-052 and Lactiplantibacillus plantarum KABPTM-051: A Randomized, Double-Blinded, Placebo-Controlled Trial (Pilot Study). J Clin Exp Dent. 2021 May 1;13(5):e433-e439. doi: 10.4317/jced.57771. eCollection 2021 May.
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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.
Jordi Espadaler Mazo, PhD study chair
AB Biotics, SA
Jose Nart Molina, DMD principal investigator
Clínica Odontológica Nart en Barcelona
Questions about this trial
What is this clinical trial studying?
A study testing AB-DENTALAC [Probiotics (study)] in people with Periodontal Disease, run by AB Biotics, SA.
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 5 inclusion and 10 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 18 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
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.
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?
Probiotic colonization of the oral cavity (qPCR) (time frame: Change from Baseline assessed 6 weeks after study entry). 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 NCT03540498, 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 18 Dec 2019.