Chronic PeriodontitisNCT01438333
Efficacy of INERSAN in Patients With Chronic Periodontitis as Adjunctive to Full Mouth Disinfection
A study testing lactobacillus brevis tablets in people with Chronic Periodontitis, run by University of L'Aquila at 1 site in Italy.
Trial summary
The purpose of this study is to evaluate beneficial effects of probiotic Lactobacillus brevis CD2 tablets in addition to the primary treatment for patients with chronic periodontitis (Full Mouth Disinfection), at local level and at systemic level. Read more about this study
- Who is it for?
- Ages 21 to 70 years
- Conditions the study is for
- Chronic Periodontitis
- What is being tested?
- lactobacillus brevis tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 15 participants
- Where
- 1 siteItaly
- Study dates
- Sep 2011to Mar 2015
- 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 21 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients between 21-70 years of age groups;
- patients with chronic periodontitis in need of primary treatment;
- patients with at least 20 fully erupted teeth;
- patients ready to give written informed consent for participating in the trial;
- patients agreeing to comply with the study protocol and instructions.
Who cannot join
- Pregnant women and lactating mothers;
- patients with debilitating systemic diseases;
- patients in needs for prophylactic antibiotics;
- patients treated with antibiotics within 30 days prior to enrollment into the study;
- patients already participant any other clinical trial or participant other investigational drug, or food supplement, in the last 30 days;
- patient having active periapical abscess or periodontal abscess or a history of acute necrotizing ulcerative gingivitis;
- patients not willing to participate in the trial.
- patients with psychiatric problems.
Trial locations and contacts
1 site in 1 country.
Italy1 site
University of L'Aquila, Division of Periodontology
L’Aquila, AQ, 67100
About this study
Official title: Efficacy of INERSAN in Patients With Chronic Periodontitis as Adjunctive to Full Mouth Disinfection: a Randomized, Double Masked, Placebo Controlled Clinical Trial
The purpose of this study is to evaluate beneficial effects of probiotic Lactobacillus brevis CD2 tablets in addition to the primary treatment for patients with chronic periodontitis (Full Mouth Disinfection), at local level and at systemic level.
Read the detailed description
This study will be conducted as a double blind, randomized, parallel group, placebo controlled clinical trial, involving subjects of 21 years of age or older to evaluate the beneficial effects of INERSAN® tablets as the primary treatment for patients with chronic periodontitis.
Patients satisfying the "Inclusion criteria" will be enrolled into the study after explaining them the objective of the study and after taking their written consent.
The probiotic tablets used in the present study contain a single strain of Lactobacilli, Lactobacillus brevis CD2, as active component. The placebo will be a mix of sugars and salts used as excipients in the active formulation. The active study medication and Placebo will be identical in appearance and organoleptic properties. Study treatment will be started from the day of enrollment and continued for 6 weeks. The daily dose of trial product will be 5 tablets per day, one tablet to be taken every 2-3 hours. The tablets will be to be kept in mouth for it to dissolve by itself. A hot beverage (e.g.: tea, coffee, milk etc.) will not to be taken for at least half an hour before and after the medication since elevated temperature could inactivate the bacteria.
The study drug and placebo will be provided as per the randomization schedule, packed in patient specific packs, bearing patient number. The study being a double masked study, both the patient and the Investigator will be blinded during the entire course of the trial. A sealed copy of the randomization codes will be given to the Principal Investigator and will be directed to open and break the codes only at the event of adverse events after discussion with sponsor and the monitor.
Patients will be informed that they may withdraw from the study at any time for any reasons. The Investigator also has the right to withdraw patients from the study if it is in the best interest of the patient. The reason and date of discontinuation will to be clearly documented in the case report form for all patients who discontinued the study product prematurely.
Periodontal examination periodontal probe depth (PPD), clinical attachment level (CAL), bleeding on probing index (BOP),plaque index (PI), and tooth mobility, will be conducted at the screening period and scheduled study visits. Photographs of the dental cavity were taken at the start and end of the study treatment.
Radiographs were compared at the beginning and end of the study to compare the bone level and record other relevant findings.
At baseline each volunteer will be received a Full Mouth Disinfection (FMD) and, to ensure that all deposits has been removed, a disclosing episode will be carried out after which any remaining plaque will be removed.
Saliva samples (at least 3 mL) will be collected in eppendorf tubes and immediately frozen at -20°C.
The activity of Arginine deiminase will be evaluated by High Performance Liquid Chromatography of fluorescence derivatized aminoacids, by monitoring the formation of citrulline from Arginine.
For metabonomic analysis the saliva samples will be collected in the morning in a sterile tube containing sodium fluoride as an antimicrobic agent. Patients must refrain from eating, drinking, smoking or dental washing before the collection.
The samples will be kept on ice and will be stored at -80°C as soon as possible.
Plaque samples will be collected with a sterile curette and dispersed in sterilized saline solution and stored at -20°C.
Microbiota will be analyzed on DNA extracted from the samples using a Qiagen kit. L.brevis CD2 strain will be detected using a TaqMan Real Time PCR, by using specifically designed primers. Microbial flora potentially involved in periodontitis, will be identified and quantified by molecular biology techniques.
Breath samples will be collected in 1 mL disposable syringe (latex-free) and immediately analyzed between a portable gas chromatograph device (Oral Chroma, Abimedical corporation, Osaka, Japan).
Blood samples (20-25mL) will be collected by only 20% of population on the study al baseline and at end of the treatment period (6 weeks).
- Conditions
- Chronic Periodontitis
- Being tested
- lactobacillus brevis tablets, PLACEBO
- Keywords
- Chronic Peridodontitis, probiotics, lactobacillus brevis, full mouth disinfection
- Medical subject headings
- Chronic Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lactobacillus brevis tabletsDietary supplement
Also called Inersan
5 tablets a day for 6 weeks
PLACEBODietary supplement
5 tablets a day for 6 weeks
| Study group | Role | What they receive |
|---|---|---|
| Lactobacillus brevis | Experimental | Not described Receives: Dietary Supplement: lactobacillus brevis tablets |
| Placebo | Placebo comparator | 5 tablets a day for 6 weeks Receives: Dietary Supplement: PLACEBO |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison in saliva and gingival crevicular fluid samples of the levels of Matrixmetalloproteinases (MMPs)
Measured: 6 weeks
Comparison in saliva and gingival crevicular fluid samples of the levels of modulators of inflammatory reaction (interleukin 1beta, interleukin 10, prostaglandin 2)
Measured: 6 weeks
Comparison in saliva samples of the levels of metabolic phenotype
Measured: 6 weeks
Secondary outcomes (6)
Comparison in saliva samples of the levels of Nitric Oxide Synthase (NOS) activity;
Measured: 6 weeks
Comparison in saliva samples of the levels of Arginine deiminase
Measured: 6 weeks
Comparison in saliva samples of the levels of lactoferrin
Measured: 6 weeks
Comparison in saliva and gingival crevicular fluid samples of the levels of subgingival bacteria (Aggregatibacter Actinomycetemcomitan, Porphyromonas gingivalis, Tannerella Forsythia, Treponema denticola)
Measured: 6 weeks
Comparison in breath samples of the levels of Volatile Sulfur Compounds (VSC)(hydrogen sulfide, methyl mercaptan, dimethyl sulfide)
Measured: 6 weeks
Comparison in blood samples of the levels of Toll Like Receptor-2 and Toll Like Receptor-4 positive B-cells
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2011 (estimated)
- Study startSep 2011
- Primary completionMar 2015
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic PeriodontitisStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of L'Aquila
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Enrico Marchetti, University of L'Aquila
- Investigators
- ENRICO MARCHETTI, DDS, Principal investigator, University of L'Aquila
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01438333
- Sponsor's protocol ID
- 07/CE/2011
- Status last verified
- Jun 2015
- First submitted
- 13 Sep 2011
- Last updated
- 17 Jun 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of INERSAN in Patients With Chronic Periodontitis as Adjunctive to Full Mouth Disinfection: a Randomized, Double Masked, Placebo Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT01438333
- Acronym / sponsor ID
- 07/CE/2011
- Conditions
- Chronic Periodontitis
- Keywords
- Chronic Peridodontitis, probiotics, lactobacillus brevis, full mouth disinfection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- University of L'AquilaUniversity, hospital or other
- Study start
- Sep 2011
- Primary completion
- Mar 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 22 Sep 2011 (estimated)
- 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 purpose of this study is to evaluate beneficial effects of probiotic Lactobacillus brevis CD2 tablets in addition to the primary treatment for patients with chronic periodontitis (Full Mouth Disinfection), at local level and at systemic level.
Detailed description
This study will be conducted as a double blind, randomized, parallel group, placebo controlled clinical trial, involving subjects of 21 years of age or older to evaluate the beneficial effects of INERSAN® tablets as the primary treatment for patients with chronic periodontitis.
Patients satisfying the "Inclusion criteria" will be enrolled into the study after explaining them the objective of the study and after taking their written consent.
The probiotic tablets used in the present study contain a single strain of Lactobacilli, Lactobacillus brevis CD2, as active component. The placebo will be a mix of sugars and salts used as excipients in the active formulation. The active study medication and Placebo will be identical in appearance and organoleptic properties. Study treatment will be started from the day of enrollment and continued for 6 weeks. The daily dose of trial product will be 5 tablets per day, one tablet to be taken every 2-3 hours. The tablets will be to be kept in mouth for it to dissolve by itself. A hot beverage (e.g.: tea, coffee, milk etc.) will not to be taken for at least half an hour before and after the medication since elevated temperature could inactivate the bacteria.
The study drug and placebo will be provided as per the randomization schedule, packed in patient specific packs, bearing patient number. The study being a double masked study, both the patient and the Investigator will be blinded during the entire course of the trial. A sealed copy of the randomization codes will be given to the Principal Investigator and will be directed to open and break the codes only at the event of adverse events after discussion with sponsor and the monitor.
Patients will be informed that they may withdraw from the study at any time for any reasons. The Investigator also has the right to withdraw patients from the study if it is in the best interest of the patient. The reason and date of discontinuation will to be clearly documented in the case report form for all patients who discontinued the study product prematurely.
Periodontal examination periodontal probe depth (PPD), clinical attachment level (CAL), bleeding on probing index (BOP),plaque index (PI), and tooth mobility, will be conducted at the screening period and scheduled study visits. Photographs of the dental cavity were taken at the start and end of the study treatment.
Radiographs were compared at the beginning and end of the study to compare the bone level and record other relevant findings.
At baseline each volunteer will be received a Full Mouth Disinfection (FMD) and, to ensure that all deposits has been removed, a disclosing episode will be carried out after which any remaining plaque will be removed.
Saliva samples (at least 3 mL) will be collected in eppendorf tubes and immediately frozen at -20°C.
The activity of Arginine deiminase will be evaluated by High Performance Liquid Chromatography of fluorescence derivatized aminoacids, by monitoring the formation of citrulline from Arginine.
For metabonomic analysis the saliva samples will be collected in the morning in a sterile tube containing sodium fluoride as an antimicrobic agent. Patients must refrain from eating, drinking, smoking or dental washing before the collection.
The samples will be kept on ice and will be stored at -80°C as soon as possible.
Plaque samples will be collected with a sterile curette and dispersed in sterilized saline solution and stored at -20°C.
Microbiota will be analyzed on DNA extracted from the samples using a Qiagen kit. L.brevis CD2 strain will be detected using a TaqMan Real Time PCR, by using specifically designed primers. Microbial flora potentially involved in periodontitis, will be identified and quantified by molecular biology techniques.
Breath samples will be collected in 1 mL disposable syringe (latex-free) and immediately analyzed between a portable gas chromatograph device (Oral Chroma, Abimedical corporation, Osaka, Japan).
Blood samples (20-25mL) will be collected by only 20% of population on the study al baseline and at end of the treatment period (6 weeks).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lactobacillus brevis | Experimental | Dietary Supplement: lactobacillus brevis tablets |
| Placebo | Placebo comparator | Dietary Supplement: PLACEBO5 tablets a day for 6 weeks |
Who may qualify
- Ages
- 21 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients between 21-70 years of age groups;
- patients with chronic periodontitis in need of primary treatment;
- patients with at least 20 fully erupted teeth;
- patients ready to give written informed consent for participating in the trial;
- patients agreeing to comply with the study protocol and instructions.
Key exclusion criteria (8 listed)
- Pregnant women and lactating mothers;
- patients with debilitating systemic diseases;
- patients in needs for prophylactic antibiotics;
- patients treated with antibiotics within 30 days prior to enrollment into the study;
- patients already participant any other clinical trial or participant other investigational drug, or food supplement, in the last 30 days;
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 |
|---|---|---|
| lactobacillus brevis tabletsAlso: Inersan5 tablets a day for 6 weeks | Dietary supplement | Lactobacillus brevis |
| PLACEBO5 tablets a day for 6 weeks | Dietary supplement | Placebo |
Primary outcome
Comparison in saliva and gingival crevicular fluid samples of the levels of Matrixmetalloproteinases (MMPs)
Time frame: 6 weeks
Comparison in saliva and gingival crevicular fluid samples of the levels of modulators of inflammatory reaction (interleukin 1beta, interleukin 10, prostaglandin 2)
Time frame: 6 weeks
Comparison in saliva samples of the levels of metabolic phenotype
Time frame: 6 weeks
6 secondary outcomes
Comparison in saliva samples of the levels of Nitric Oxide Synthase (NOS) activity;
Time frame: 6 weeks
Comparison in saliva samples of the levels of Arginine deiminase
Time frame: 6 weeks
Comparison in saliva samples of the levels of lactoferrin
Time frame: 6 weeks
Comparison in saliva and gingival crevicular fluid samples of the levels of subgingival bacteria (Aggregatibacter Actinomycetemcomitan, Porphyromonas gingivalis, Tannerella Forsythia, Treponema denticola)
Time frame: 6 weeks
Comparison in breath samples of the levels of Volatile Sulfur Compounds (VSC)(hydrogen sulfide, methyl mercaptan, dimethyl sulfide)
Time frame: 6 weeks
Comparison in blood samples of the levels of Toll Like Receptor-2 and Toll Like Receptor-4 positive B-cells
Time frame: 6 weeks
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 17 Jun 2015.
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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.
ENRICO MARCHETTI, DDS principal investigator
University of L'Aquila
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing lactobacillus brevis tablets in people with Chronic Periodontitis, run by University of L'Aquila at 1 site in Italy.
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 8 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 17 Jun 2015. 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 Italy. 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.
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?
Comparison in saliva and gingival crevicular fluid samples of the levels of Matrixmetalloproteinases (MMPs) (time frame: 6 weeks). 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?
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 17 Jun 2015.