Chronic PeriodontitisPhase 3NCT01870362
Efficacy of a Probiotic Lozenge (Inersan) in Patients With Chronic Periodontitis
A Phase 3 study testing Probiotic (Inersan) in people with Chronic Periodontitis, run by CD Pharma India Pvt. Ltd. at 1 site in India.
Trial summary
Periodontal disease is a major cause of tooth loss in humans and is one of the most prevalent diseases associated with bone loss. Following bacterial colonization, the gingiva becomes inflamed leading, in some cases, to the destruction of the alveolar bone. Read more about this study
- Who is it for?
- Ages 25 to 60 years
- Conditions the study is for
- Chronic Periodontitis
- What is being tested?
- Probiotic (Inersan)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 28 participants
- Where
- 1 siteIndia
- Study dates
- Jun 2013to Jul 2014
- 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 25 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Subjects of both sexes
- Patients in the age group of 25-60 years
- Subjects with mild to moderate chronic periodontitis, as defined by probing pocket depths 5-7mm in > 30 % of the probing sites
- The subjects should have at least 16 remaining natural teeth (minimum of at least 4 teeth per quadrant)
- Subjects in good general health
Who cannot join
- No antibiotic therapy in the past 2 months
- Medically compromised patients
- Subjects who are pregnant/ lactating
- Smokers and/or alcoholics.
- Those who had undergone any dental surgical or non-surgical therapy within 6 months prior to the start of the study.
Trial locations and contacts
1 site in 1 country.
India1 site
Mahatma Gandhi Post Graduate Institute of Dental Sciences (MGPGI)
Puducherry, Puducherry, 605006
About this study
Official title: Improvement of Periodontal Health and Reduction in Periodontal Plaque Micro-flora Using a Probiotic Lozenge in Patients With Chronic Periodontitis
Periodontal disease is a major cause of tooth loss in humans and is one of the most prevalent diseases associated with bone loss. Following bacterial colonization, the gingiva becomes inflamed leading, in some cases, to the destruction of the alveolar bone. Periodontitis has two distinct but interconnected etiologic components, periodontopathic bacteria and host-mediated connective tissue-destructive responses to the causative bacteria and their metabolic products.
A few studies have revealed that probiotic Lactobacillus strains were useful in reducing gingival inflammation and the number of black-pigmented rods, including Porphyromonas gingivalis (Pg), in the saliva and sub-gingival plaque. Concerning periodontal conditions, its shown that application of beneficial bacteria, as an adjunct to scaling and root planing (SRP), can inhibit re-colonization of pathogens in periodontal pockets and reduce bleeding on probing.
The aim of the present study is to evaluate the improvement of periodontal health with probiotic (Inersan) lozenges, used as an adjunct to scaling and root planing [SRP].
- Conditions
- Chronic Periodontitis
- Being tested
- Probiotic (Inersan), Placebo
- Medical subject headings
- Chronic Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Probiotic (Inersan)Drug
Also called Inersan contains not less than 1 billion CFU of Lactobacillus brevis CD2
PlaceboDrug
Also called Placebo contains all excipients except the active constituent (Lactobacillus brevis CD2)
| Study group | Role | What they receive |
|---|---|---|
| Probiotic (Inersan) Arm | Experimental | Inersan Lozenges (2 Lozenges bid). Each probiotic lozenge contains not less than 1 billion CFU of L. brevis CD2 Receives: Drug: Probiotic (Inersan) |
| Placebo Arm | Placebo comparator | Placebo Lozenges (2 lozenges bid). Placebo lozenge contains only excipients (without probiotic). Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in periodontal indices
Improvement in Periodontal indices, namely, plaque index [PI], Gingival index [GI], Gingival bleeding index [GBI], probing pocket depth [PPD] and clinical attachment levels [CAL] in both groups
Measured: 6 weeks, 12 weeks
Secondary outcomes (1)
Microbiological indices
Changes in pathogen (Aggregatibacter actinomycetemcomitans (Aa), Porphyromonas gingivalis (Pg), and Prevotella intermedia) levels
Measured: 6 weeks, 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2013 (estimated)
- Study startJun 2013
- Primary completionJul 2014
- Study completionJul 2014
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- CD Pharma India Pvt. Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Mahatma Gandhi Postgraduate Institute of Dental Sciences
- Responsible party
- Sponsor
- Investigators
- Grace T Paul, MBBS, MDS, Principal investigator, Mahatma Gandhi Post- Graduate Institute of Dental Sciences, Pondicherry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01870362
- Sponsor's protocol ID
- prob-gracetpaul_01
- Status last verified
- Jul 2014
- First submitted
- 3 Jun 2013
- Last updated
- 23 Jul 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improvement of Periodontal Health and Reduction in Periodontal Plaque Micro-flora Using a Probiotic Lozenge in Patients With Chronic Periodontitis
- ClinicalTrials.gov ID
- NCT01870362
- Acronym / sponsor ID
- prob-gracetpaul_01
- Conditions
- Chronic Periodontitis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- CD Pharma India Pvt. Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Mahatma Gandhi Postgraduate Institute of Dental Sciences
- Study start
- Jun 2013
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 6 Jun 2013 (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.
Periodontal disease is a major cause of tooth loss in humans and is one of the most prevalent diseases associated with bone loss. Following bacterial colonization, the gingiva becomes inflamed leading, in some cases, to the destruction of the alveolar bone. Periodontitis has two distinct but interconnected etiologic components, periodontopathic bacteria and host-mediated connective tissue-destructive responses to the causative bacteria and their metabolic products.
A few studies have revealed that probiotic Lactobacillus strains were useful in reducing gingival inflammation and the number of black-pigmented rods, including Porphyromonas gingivalis (Pg), in the saliva and sub-gingival plaque. Concerning periodontal conditions, its shown that application of beneficial bacteria, as an adjunct to scaling and root planing (SRP), can inhibit re-colonization of pathogens in periodontal pockets and reduce bleeding on probing.
The aim of the present study is to evaluate the improvement of periodontal health with probiotic (Inersan) lozenges, used as an adjunct to scaling and root planing [SRP].
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 (Inersan) Arm | Experimental | Drug: Probiotic (Inersan)Inersan Lozenges (2 Lozenges bid). Each probiotic lozenge contains not less than 1 billion CFU of L. brevis CD2 |
| Placebo Arm | Placebo comparator | Drug: PlaceboPlacebo Lozenges (2 lozenges bid). Placebo lozenge contains only excipients (without probiotic). |
Who may qualify
- Ages
- 25 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Subjects of both sexes
- Patients in the age group of 25-60 years
- Subjects with mild to moderate chronic periodontitis, as defined by probing pocket depths 5-7mm in > 30 % of the probing sites
- The subjects should have at least 16 remaining natural teeth (minimum of at least 4 teeth per quadrant)
- Subjects in good general health
Key exclusion criteria (5 listed)
- No antibiotic therapy in the past 2 months
- Medically compromised patients
- Subjects who are pregnant/ lactating
- Smokers and/or alcoholics.
- Those who had undergone any dental surgical or non-surgical therapy within 6 months prior to the start of the study.
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 (Inersan)Also: Inersan contains not less than 1 billion CFU of Lactobacillus brevis CD2 | Drug | Probiotic (Inersan) Arm |
| PlaceboAlso: Placebo contains all excipients except the active constituent (Lactobacillus brevis CD2) | Drug | Placebo Arm |
Primary outcome
Improvement in periodontal indices
Time frame: 6 weeks, 12 weeks
Improvement in Periodontal indices, namely, plaque index [PI], Gingival index [GI], Gingival bleeding index [GBI], probing pocket depth [PPD] and clinical attachment levels [CAL] in both groups
1 secondary outcome
Microbiological indices
Time frame: 6 weeks, 12 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 23 Jul 2014.
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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.
Grace T Paul, MBBS, MDS principal investigator
Mahatma Gandhi Post- Graduate Institute of Dental Sciences, Pondicherry
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 (Inersan) in people with 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 5 inclusion and 5 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 23 Jul 2014. 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 periodontal indices (time frame: 6 weeks, 12 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 23 Jul 2014.