Mild and Moderate Chronic PeriodontitisPhase 3NCT02203812
Effect of Probiotic Lozenge on Gingivitis and Periodontitis
A Phase 3 study testing Probiotic Arm in people with Mild and Moderate Chronic Periodontitis, run by CD Pharma India Pvt. Ltd. at 1 site in India.
Trial summary
The oral cavity is mostly influenced by general health. The oral microbiota which is as complex as the gastro-intestinal or vaginal microbiota are considered to be difficult therapeutic targets. Read more about this study
- Who is it for?
- Ages 20 to 50 years
- Conditions the study is for
- Mild and Moderate Chronic Periodontitis
- What is being tested?
- Probiotic Arm
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteIndia
- Study dates
- Jan 2015to May 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 20 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients with chronic mild to moderate periodontitis.
- Having Pocket depth > 4mm.
- Mean loss of attachment, evaluated by measuring the distance from cement-enamel junction to the bottom of the probing pocket > 4mm
Who cannot join
- Patients on probiotic supplements
- Patients who have allergy to lactose and fermented milk products
- Smokers
- Patients who are on antibiotic therapy or were on antibiotic therapy in the past 6 months
- Patients with advanced periodontal and/or periapical conditions which necessitate immediate treatment
- Patient suffering from any systemic illness
- Patients who are deemed to be un-cooperative
Trial locations and contacts
1 site in 1 country.
India1 site
Department of Periodontology, Government Dental College & Hospital
Vijayawada, Andhra Pradesh, 520004
About this study
Official title: The Effect of Probiotic Lozenge Administration on Gingivitis and on Mild & Moderate Periodontitis: A Randomized Controlled Clinical Trial.
The oral cavity is mostly influenced by general health. The oral microbiota which is as complex as the gastro-intestinal or vaginal microbiota are considered to be difficult therapeutic targets. The effects of probiotics in different fields of health care have resulted recently in the introduction of probiotics for oral healthcare. Probiotics have been clinically proved effective in different fields of oral healthcare such as halitosis, oral candidiasis and tooth decay. They have also been inducted in the field of periodontal healthcare because of the current views on the etiology of plaque- related periodontal inflammation.
- Conditions
- Mild and Moderate Chronic Periodontitis
- Being tested
- Probiotic Arm, Placebo Arm
- Medical subject headings
- Lymphoma, Follicular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Probiotic ArmDrug
Each Inersan lozenge contains at least 1 billion colony forming unit of Lactobacillus brevis CD2
Placebo ArmDrug
Placebo lozenges contain all ingredients except the active constituent (probiotic, Lactobacillus brevis CD2)
| Study group | Role | What they receive |
|---|---|---|
| Probiotic Arm | Experimental | L. brevis CD2 Lozenges (4 lozenges per day - 1 lozenge in the morning, 1 lozenge in the afternoon and 2 lozenges in the night). Each lozenge contains at least 1 billion colony forming units of Lactobacillus brevis CD2. Receives: Drug: Probiotic Arm |
| Placebo Arm | Placebo comparator | Placebo lozenges (4 lozenges per day - 1 lozenge in the morning, 1 lozenge in the afternoon and 2 lozenges in the night). The placebo lozenge contains all ingredients except the active constituent (probiotic, Lactobacillus brevis CD2). Receives: Drug: Placebo Arm |
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), Bleeding on Probing (BOP)
Measured: 8 weeks
Secondary outcomes (1)
Improvement in Biochemical Indices
Changes in levels of Inflammatory markers, namely, Interleukin 1β, Matrix metalloproteinases-8 (MMP), Myeloperoxidase (MPO) and Calprotectin in Gingival Crevicular Fluid (GCF)
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 posted30 Jul 2014 (estimated)
- Study startJan 2015
- Primary completionFeb 2016
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild and Moderate 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- CD Pharma India Pvt. Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Government Dental College and Hospital, Vijayawada, Andra Pradesh, India
- Responsible party
- Sponsor
- Investigators
- Surya Jyotsna Kiran Kanchumurthy, BDS, Principal investigator, Government Dental College and Hospital, Vijayawada, Andhra PradeshNarendra Dev Jampani, MDS, Study director, Government Dental College and Hospital, Vijayawada, Andhra PradeshVajra Madhuri S, MDS, Principal investigator, Government Dental College and Hospital, Vijayawada, Andhra Pradesh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02203812
- Sponsor's protocol ID
- VIJ_GIN-PRO 01
- Status last verified
- Jul 2016
- First submitted
- 28 Jul 2014
- Last updated
- 27 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Probiotic Lozenge Administration on Gingivitis and on Mild & Moderate Periodontitis: A Randomized Controlled Clinical Trial.
- ClinicalTrials.gov ID
- NCT02203812
- Acronym / sponsor ID
- VIJ_GIN-PRO 01
- Conditions
- Mild and Moderate Chronic Periodontitis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- CD Pharma India Pvt. Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Government Dental College and Hospital, Vijayawada, Andra Pradesh, India
- Study start
- Jan 2015
- Primary completion
- Feb 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 30 Jul 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.
The oral cavity is mostly influenced by general health. The oral microbiota which is as complex as the gastro-intestinal or vaginal microbiota are considered to be difficult therapeutic targets. The effects of probiotics in different fields of health care have resulted recently in the introduction of probiotics for oral healthcare. Probiotics have been clinically proved effective in different fields of oral healthcare such as halitosis, oral candidiasis and tooth decay. They have also been inducted in the field of periodontal healthcare because of the current views on the etiology of plaque- related periodontal inflammation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Probiotic Arm | Experimental | Drug: Probiotic ArmL. brevis CD2 Lozenges (4 lozenges per day - 1 lozenge in the morning, 1 lozenge in the afternoon and 2 lozenges in the night). Each lozenge contains at least 1 billion colony forming units of Lactobacillus brevis CD2. |
| Placebo Arm | Placebo comparator | Drug: Placebo ArmPlacebo lozenges (4 lozenges per day - 1 lozenge in the morning, 1 lozenge in the afternoon and 2 lozenges in the night). The placebo lozenge contains all ingredients except the active constituent (probiotic, Lactobacillus brevis CD2). |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Patients with chronic mild to moderate periodontitis.
- Having Pocket depth > 4mm.
- Mean loss of attachment, evaluated by measuring the distance from cement-enamel junction to the bottom of the probing pocket > 4mm
Key exclusion criteria (7 listed)
- Patients on probiotic supplements
- Patients who have allergy to lactose and fermented milk products
- Smokers
- Patients who are on antibiotic therapy or were on antibiotic therapy in the past 6 months
- Patients with advanced periodontal and/or periapical conditions which necessitate immediate 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 |
|---|---|---|
| Probiotic ArmEach Inersan lozenge contains at least 1 billion colony forming unit of Lactobacillus brevis CD2 | Drug | Probiotic Arm |
| Placebo ArmPlacebo lozenges contain all ingredients except the active constituent (probiotic, Lactobacillus brevis CD2) | Drug | Placebo Arm |
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), Bleeding on Probing (BOP)
1 secondary outcome
Improvement in Biochemical 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 27 Jul 2016.
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.
Surya Jyotsna Kiran Kanchumurthy, BDS principal investigator
Government Dental College and Hospital, Vijayawada, Andhra Pradesh
Narendra Dev Jampani, MDS study director
Government Dental College and Hospital, Vijayawada, Andhra Pradesh
Vajra Madhuri S, MDS principal investigator
Government Dental College and Hospital, Vijayawada, Andhra Pradesh
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 Probiotic Arm in people with Mild and Moderate Chronic Periodontitis, run by CD 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 3 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 27 Jul 2016. 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. 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 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 27 Jul 2016; AzTrials last refreshed its copy on 7 Nov 2026.