Chronic PeriodontitisPhase 3NCT02329353
Effect of Probiotics on Chronic Periodontitis in Smoker and Non- Smokers
A Phase 3 study testing Lactobacillus brevis CD2 Lozenges in people with Chronic Periodontitis, run by Next Gen Pharma India Pvt. Ltd. at 1 site in India.
Trial summary
Periodontitis is one of the most common chronic inflammatory disease with the etiology of bacterial plaque and is associated with a number of putative bacterial species. The periodontal destruction is substantially mediated by the host, driven by the bacterial challenge. Read more about this study
- Who is it for?
- Ages 30 to 55 years
- Conditions the study is for
- Chronic Periodontitis
- What is being tested?
- Lactobacillus brevis CD2 Lozenges
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteIndia
- Study dates
- Feb 2015to Dec 2016
- Phase
- Phase 3
- 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 30 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients free from any systemic illness
- Previously untreated moderate to severe generalised chronic periodontitis.
- Patients free from adverse reactions to lactose or fermented milk products
- Patient unwilling to quit smoking and smokers over the past one year ( Smoker arm).
Who cannot join
- Previous history of antibiotic usage over past 6 months
- Patients who are eligible for antibiotic usage during the treatment course
- Patients who are pregnant, lactating, alcoholic or who had undergone any surgical or nonsurgical therapy within 6 months.
- Acute oral lesions or necrotising ulcerative periodontitis
Trial locations and contacts
1 site in 1 country.
India1 site
Krishnadevaraya College of Dental Sciences and Hospital
Bangalore, Karnataka, 562157
About this study
Official title: Clinical And Microbiological Analysis Of Orally Administered Lactobacillus Probiotic Lozenges In Chronic Periodontitis Patients Among Smokers And Non-smokers And Its Correlation With Clinical Parameters - A Clinico-Microbiological Study
Periodontitis is one of the most common chronic inflammatory disease with the etiology of bacterial plaque and is associated with a number of putative bacterial species. The periodontal destruction is substantially mediated by the host, driven by the bacterial challenge. The presence of pathogenic bacteria with the absence of so-called "beneficial bacteria" and the susceptibility of the host are the main aetiological factors of periodontal diseases.
- Conditions
- Chronic Periodontitis
- Being tested
- Lactobacillus brevis CD2 Lozenges
- 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 CD2 LozengesDrug
Also called Probiotics
Each lozenge contains not less than 1 billion Colony forming unit of Lactobacillus brevis CD2
| Study group | Role | What they receive |
|---|---|---|
| Smoker group | Experimental | 30 chronic periodontitis patients, having habit of smoking, with probing pocket depth of equal or greater than 5 mm with bleeding on probing and radio-graphic evidence of bone loss in at at least 2 sites at each quadrant will be given three probiotic lozenge per day for 8 weeks Receives: Drug: Lactobacillus brevis CD2 Lozenges |
| Non-smoker | Experimental | 30 chronic periodontitis patients, not having habit of smoking, with probing pocket depth of equal or greater than 5 mm with bleeding on probing and radio-graphic evidence of bone loss in at at least 2 sites at each quadrant will be given three probiotic lozenge per day for 8 weeks Receives: Drug: Lactobacillus brevis CD2 Lozenges |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in Clinical Periodontal Indices
Improvement in clinical periodontal indices, namely, Plaque Index (PI), Gingival Index (GI), Probing Pocket Depth (PPD)
Measured: 8 weeks
Secondary outcomes (1)
Change in microbiological indices
Porphyromonas gingivalis, Tanerella forsythus
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2014 (estimated)
- Study startFeb 2015
- Primary completionNov 2016
- Study completionDec 2016
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 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Next Gen Pharma India Pvt. Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Krishnadevaraya College of Dental Sciences & Hospital
- Responsible party
- Sponsor
- Investigators
- Rudrakshi chickanna, MDS, Principal investigator, KRISHNADEVARAYA COLLEGE OF DENTAL SCIENCES AND HOSPITAL, BANGALOREShruthi J R, BDS, Principal investigator, KRISHNADEVARAYA COLLEGE OF DENTAL SCIENCES AND HOSPITAL, BANGALOREPrabhuji MLV, MDS, Principal investigator, KRISHNADEVARAYA COLLEGE OF DENTAL SCIENCES AND HOSPITAL, BANGALORE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02329353
- Sponsor's protocol ID
- BAN_PERIO-SOM_01
- Status last verified
- Jan 2017
- First submitted
- 29 Dec 2014
- Last updated
- 10 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical And Microbiological Analysis Of Orally Administered Lactobacillus Probiotic Lozenges In Chronic Periodontitis Patients Among Smokers And Non-smokers And Its Correlation With Clinical Parameters - A Clinico-Microbiological Study
- ClinicalTrials.gov ID
- NCT02329353
- Acronym / sponsor ID
- BAN_PERIO-SOM_01
- Conditions
- Chronic Periodontitis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Next Gen Pharma India Pvt. Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Krishnadevaraya College of Dental Sciences & Hospital
- Study start
- Feb 2015
- Primary completion
- Nov 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 31 Dec 2014 (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.
Periodontitis is one of the most common chronic inflammatory disease with the etiology of bacterial plaque and is associated with a number of putative bacterial species. The periodontal destruction is substantially mediated by the host, driven by the bacterial challenge. The presence of pathogenic bacteria with the absence of so-called "beneficial bacteria" and the susceptibility of the host are the main aetiological factors of periodontal diseases.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Smoker group | Experimental | Drug: Lactobacillus brevis CD2 Lozenges30 chronic periodontitis patients, having habit of smoking, with probing pocket depth of equal or greater than 5 mm with bleeding on probing and radio-graphic evidence of bone loss in at at least 2 sites at each quadrant will be given three probiotic lozenge per day for 8 weeks |
| Non-smoker | Experimental | Drug: Lactobacillus brevis CD2 Lozenges30 chronic periodontitis patients, not having habit of smoking, with probing pocket depth of equal or greater than 5 mm with bleeding on probing and radio-graphic evidence of bone loss in at at least 2 sites at each quadrant will be given three probiotic lozenge per day for 8 weeks |
Who may qualify
- Ages
- 30 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Patients free from any systemic illness
- Previously untreated moderate to severe generalised chronic periodontitis.
- Patients free from adverse reactions to lactose or fermented milk products
- Patient unwilling to quit smoking and smokers over the past one year ( Smoker arm).
Key exclusion criteria (4 listed)
- Previous history of antibiotic usage over past 6 months
- Patients who are eligible for antibiotic usage during the treatment course
- Patients who are pregnant, lactating, alcoholic or who had undergone any surgical or nonsurgical therapy within 6 months.
- Acute oral lesions or necrotising ulcerative periodontitis
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 CD2 LozengesAlso: ProbioticsEach lozenge contains not less than 1 billion Colony forming unit of Lactobacillus brevis CD2 | Drug | Non-smoker, Smoker group |
Primary outcome
Improvement in Clinical Periodontal Indices
Time frame: 8 weeks
Improvement in clinical periodontal indices, namely, Plaque Index (PI), Gingival Index (GI), Probing Pocket Depth (PPD)
1 secondary outcome
Change in microbiological indices
Time frame: 8 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 10 Jan 2017.
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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.
Rudrakshi chickanna, MDS principal investigator
KRISHNADEVARAYA COLLEGE OF DENTAL SCIENCES AND HOSPITAL, BANGALORE
Shruthi J R, BDS principal investigator
KRISHNADEVARAYA COLLEGE OF DENTAL SCIENCES AND HOSPITAL, BANGALORE
Prabhuji MLV, MDS principal investigator
KRISHNADEVARAYA COLLEGE OF DENTAL SCIENCES AND HOSPITAL, BANGALORE
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Lactobacillus brevis CD2 Lozenges in people with Chronic Periodontitis, run by Next Gen Pharma India Pvt. Ltd. at 1 site in India.
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 4 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 10 Jan 2017. 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 India. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Improvement in Clinical Periodontal Indices (time frame: 8 weeks). 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 10 Jan 2017.