Chronic PeriodontitisPhase 3NCT02390687
Evaluation of the Efficacy of Probiotics in Chronic Periodontitis Patients
A Phase 3 study testing Probiotic in people with Chronic Periodontitis, run by Next Gen Pharma India Pvt. Ltd. at 1 site in India.
Trial summary
Periodontitis is an infectious inflammatory disease. Bacteria modulate the inflammatory response and alter the diversity of periodontal disease. In recent years, various host-response modulation therapies have been developed to block the pathways responsible for periodontal tissue breakdown. Read more about this study
- Who is it for?
- Ages 35 to 49 years
- Conditions the study is for
- Chronic Periodontitis
- What is being tested?
- Probiotic
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 31 participants
- Where
- 1 siteIndia
- Study dates
- Apr 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 35 to 49 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Clinically diagnosed chronic generalized periodontitis
- Need of phase 1 therapy
- Pocket probing depth (PPD) of ≥ 5 mm < 7 mm at two and/or more sites
- Patients with no history of allergies to the drugs to be used
Who cannot join
- Patients on antibiotics within 3 month prior to study
- Patients with any systemic diseases
- Patients with history of any periodontal therapy within 6 months to trial
Trial locations and contacts
1 site in 1 country.
India1 site
Department of Periodontics, K.V.G. College & Hospital,
Kurunjibhag, Sullia (d.k.), Karnataka, 574327
About this study
Official title: Evaluation of the Efficacy of Probiotics in Chronic Periodontitis Patients-A Randomized Placebo Controlled Study.
Periodontitis is an infectious inflammatory disease. Bacteria modulate the inflammatory response and alter the diversity of periodontal disease. In recent years, various host-response modulation therapies have been developed to block the pathways responsible for periodontal tissue breakdown.
There have been significant changes with respect to the effectiveness of, and attitudes towards conventional antimicrobial therapy to combat disease. With the threat of widespread antibiotic resistance rendering many antibiotics useless against important diseases, there is an increased necessity not only to minimise antibiotic use and develop novel non-antibiotic-based treatments, but also to raise the profile of disease prevention. One approach that has gained interest over recent years is the use of probiotic bacteria for oral applications. The rationale for their use in oral health care stems from the increase in evidence that supports their claims for benefit for a range of diseases. Lactobacilli play an important role in the maintenance of health by stimulating the natural immunity as well as by contributing to the balance of the microflora, by interacting with the other members of the flora. The application of health promoting bacteria for therapeutic purposes, is one of the strongest emerging fields. Time has come to shift the paradigm of the treatment from specific bacteria elimination to alteration of the bacterial ecology by using probiotics.
So the purpose of this study is to discover a more promising approach for the treatment of chronic periodontitis .
- Conditions
- Chronic Periodontitis
- Being tested
- Probiotic, 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.
ProbioticDrug
Also called L. brevis CD2 Lozenges
Each probiotic lozenge contains not less than 1 billion colony forming unit of Lactobacillus brevis CD2
PlaceboDrug
Each placebo lozenge contains all excipients except the active constituent (Lactobacillus brevis CD2)
| Study group | Role | What they receive |
|---|---|---|
| Placebo Arm | Placebo comparator | Placebo Lozenges (3 Lozenges per day; 1 lozenge in morning and 2 lozenges in the night). Each placebo lozenge contains all excipients except the active constituent (Lactobacillus brevis CD2) Receives: Drug: Placebo |
| Probiotic Arm | Experimental | L. brevis CD2 Lozenges (3 Lozenges per day; 1 lozenge in morning and 2 lozenges in the night). Each probiotic lozenge contains not less than 1 billion CFU of L. brevis CD2 Receives: Drug: Probiotic |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in Periodontal Clinical indices
Improvement in periodontal clinical indices, namely, Gingival Index (GI), Bleeding on probing (BOP), Probing Pocket Depth (PPD) and Clinical attachment Loss (CAL).
Measured: 8 weeks
Secondary outcomes (1)
Change in bone pattern
Assessment of changes in bone patterns in bith group using digital radio-graphic technique
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 posted17 Mar 2015 (estimated)
- Study startApr 2015
- Primary completionSep 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Next Gen Pharma India Pvt. Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- KVG Medical College and Hospital
- Responsible party
- Sponsor
- Investigators
- Mudnoor M Dayakar, MDS, Principal investigator, KVG Medical College & Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02390687
- Sponsor's protocol ID
- SUL_PERIO-RG_01
- Status last verified
- Jan 2017
- First submitted
- 11 Mar 2015
- 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
- Evaluation of the Efficacy of Probiotics in Chronic Periodontitis Patients-A Randomized Placebo Controlled Study.
- ClinicalTrials.gov ID
- NCT02390687
- Acronym / sponsor ID
- SUL_PERIO-RG_01
- Conditions
- Chronic Periodontitis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Next Gen Pharma India Pvt. Ltd.Industry (pharma, biotech, devices)
- Collaborators
- KVG Medical College and Hospital
- Study start
- Apr 2015
- Primary completion
- Sep 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 17 Mar 2015 (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 an infectious inflammatory disease. Bacteria modulate the inflammatory response and alter the diversity of periodontal disease. In recent years, various host-response modulation therapies have been developed to block the pathways responsible for periodontal tissue breakdown.
There have been significant changes with respect to the effectiveness of, and attitudes towards conventional antimicrobial therapy to combat disease. With the threat of widespread antibiotic resistance rendering many antibiotics useless against important diseases, there is an increased necessity not only to minimise antibiotic use and develop novel non-antibiotic-based treatments, but also to raise the profile of disease prevention. One approach that has gained interest over recent years is the use of probiotic bacteria for oral applications. The rationale for their use in oral health care stems from the increase in evidence that supports their claims for benefit for a range of diseases. Lactobacilli play an important role in the maintenance of health by stimulating the natural immunity as well as by contributing to the balance of the microflora, by interacting with the other members of the flora. The application of health promoting bacteria for therapeutic purposes, is one of the strongest emerging fields. Time has come to shift the paradigm of the treatment from specific bacteria elimination to alteration of the bacterial ecology by using probiotics.
So the purpose of this study is to discover a more promising approach for the treatment of chronic periodontitis .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo Arm | Placebo comparator | Drug: PlaceboPlacebo Lozenges (3 Lozenges per day; 1 lozenge in morning and 2 lozenges in the night). Each placebo lozenge contains all excipients except the active constituent (Lactobacillus brevis CD2) |
| Probiotic Arm | Experimental | Drug: ProbioticL. brevis CD2 Lozenges (3 Lozenges per day; 1 lozenge in morning and 2 lozenges in the night). Each probiotic lozenge contains not less than 1 billion CFU of L. brevis CD2 |
Who may qualify
- Ages
- 35 to 49 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Clinically diagnosed chronic generalized periodontitis
- Need of phase 1 therapy
- Pocket probing depth (PPD) of ≥ 5 mm < 7 mm at two and/or more sites
- Patients with no history of allergies to the drugs to be used
Key exclusion criteria (3 listed)
- Patients on antibiotics within 3 month prior to study
- Patients with any systemic diseases
- Patients with history of any periodontal therapy within 6 months to trial
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 |
|---|---|---|
| ProbioticAlso: L. brevis CD2 LozengesEach probiotic lozenge contains not less than 1 billion colony forming unit of Lactobacillus brevis CD2 | Drug | Probiotic Arm |
| PlaceboEach placebo lozenge contains all excipients except the active constituent (Lactobacillus brevis CD2) | Drug | Placebo Arm |
Primary outcome
Improvement in Periodontal Clinical indices
Time frame: 8 weeks
Improvement in periodontal clinical indices, namely, Gingival Index (GI), Bleeding on probing (BOP), Probing Pocket Depth (PPD) and Clinical attachment Loss (CAL).
1 secondary outcome
Change in bone pattern
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.
Mudnoor M Dayakar, MDS principal investigator
KVG Medical College & Hospital
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 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 3 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. 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 Clinical 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.