Chronic PeriodontitisPhase 3NCT02174757
Effect of Probiotic Inersan and Doxycycline in Chronic Periodontitis
A Phase 3 study testing Inersan and Doxycycline in people with Chronic Periodontitis, run by CD Pharma India Pvt. Ltd. at 1 site in India.
Trial summary
Periodontitis is a multifactorial disease that can lead to the destruction of supporting tissues of the teeth resulting in pocket formation, recession or both. Since the primary etiological factors for periodontal disease are bacteria in supra and sub gingival biofilm, efforts for disease prevention and treatment are… 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?
- Inersan and Doxycycline
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteIndia
- Study dates
- Aug 2014to Nov 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 in both sexes
- Age 25 - 60 yrs
- Subjects with mild to moderate chronic periodontitis, as defined by probing pocket depths ≥ 5mm in > 30 % of the probing sites
- Subjects in good general health
Who cannot join
- Antibiotic therapy in the past 2 months
- Allergic to doxycycline or probiotics
- Subjects with diabetic mellitus, hypertension and psychiatric disorders
- Subjects who are pregnant/ lactating
- Smokers and/or alcoholics
- Subjects who have undergone any periodontal therapy within last 6 months.
Trial locations and contacts
1 site in 1 country.
India1 site
Dept. of Periodontics and Implantology, Sree Mookambika Institute of Dental Sciences
Kulasegaram, Tamil Naidu, 629161
About this study
Official title: A Comparative Evaluation of the Effect of Probiotic Inersan and Doxycycline on Chronic Periodontitis - A Clinical and Microbiological Study
Periodontitis is a multifactorial disease that can lead to the destruction of supporting tissues of the teeth resulting in pocket formation, recession or both. Since the primary etiological factors for periodontal disease are bacteria in supra and sub gingival biofilm, efforts for disease prevention and treatment are mainly focused on pathogen reduction and strengthening of epithelial barrier, thus contributing to decreased susceptibility to infection. Due to emergence of antibiotic resistance and frequent recolonization of treated sites with pathogenic bacteria, there was need for a new treatment paradigm to be introduced to periodontal disease. The need was fulfilled by the introduction of Probiotics and Bacterial Replacement Therapy. The term probiotic is derived from the Greek, meaning "for life" are microorganisms proven to exert health promoting influences in humans and animals. Food and Agriculture Organization and WHO have stated that there is potential for probiotic foods to provide health benefits and that specific strains are safe for human use.
- Conditions
- Chronic Periodontitis
- Being tested
- Inersan, Doxycycline
- Medical subject headings
- Chronic Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InersanDrug
Also called Each lozenge contains not less than 1 billion CFU of Lactobacillus brevis CD2
Probiotic
DoxycyclineDrug
Also called Each tablet contains 100 mg of Doxycycline
Antibiotic
| Study group | Role | What they receive |
|---|---|---|
| Inersan | Experimental | Inersan - 2 Lozenges daily (one lozenge in morning and one lozenge in night) for 2 weeks. Each lozenge contains at least 1 billion CFU of Lactobacillus brevis CD2. Receives: Drug: Inersan |
| Inersan and Doxycycline together | Experimental | Doxycycline: 1 Tablet once daily (in afternoon) for 2 weeks. Each tablet contains 100 mg Doxycycline.
Inersan - 2 Lozenges daily (one lozenge in morning and one lozenge in night) for 2 weeks. Each lozenge contains at least 1 billion CFU of Lactobacillus brevis CD2. Receives: Drug: Inersan; Drug: Doxycycline |
| Doxycycline | Active comparator | Doxycycline: 1 Tablet once daily (in afternoon) for 2 weeks. Each tablet contains 100 mg Doxycycline. Receives: Drug: Doxycycline |
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), Probing Pocket Depth (PPD), Plaque Index (PI) and Clinical Attachment level (CAL)
Measured: 4 weeks
Secondary outcomes (1)
Improvement in microbiological indices
Changes in salivary count of Lactobacilli and Porphyromonas gingivalis
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2014 (estimated)
- Study startAug 2014
- Primary completionNov 2014
- Study completionNov 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
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- CD Pharma India Pvt. Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Sree Mookambika Institute of Dental Sciences
- Responsible party
- Sponsor
- Investigators
- Arya K.S., BDS, Principal investigator, Sree Mookambika Institute of Dental SciencesElizabeth Koshi, MDS, Study director, Sree Mookambika Institute of Dental SciencesArun Sadasivan, MDS, Principal investigator, Sree Mookambika Institute of Dental Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02174757
- Sponsor's protocol ID
- KUL_SMIDS_PERIO_01
- Status last verified
- Dec 2014
- First submitted
- 19 Jun 2014
- Last updated
- 15 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Evaluation of the Effect of Probiotic Inersan and Doxycycline on Chronic Periodontitis - A Clinical and Microbiological Study
- ClinicalTrials.gov ID
- NCT02174757
- Acronym / sponsor ID
- KUL_SMIDS_PERIO_01
- Conditions
- Chronic Periodontitis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- CD Pharma India Pvt. Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Sree Mookambika Institute of Dental Sciences
- Study start
- Aug 2014
- Primary completion
- Nov 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 26 Jun 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 a multifactorial disease that can lead to the destruction of supporting tissues of the teeth resulting in pocket formation, recession or both. Since the primary etiological factors for periodontal disease are bacteria in supra and sub gingival biofilm, efforts for disease prevention and treatment are mainly focused on pathogen reduction and strengthening of epithelial barrier, thus contributing to decreased susceptibility to infection. Due to emergence of antibiotic resistance and frequent recolonization of treated sites with pathogenic bacteria, there was need for a new treatment paradigm to be introduced to periodontal disease. The need was fulfilled by the introduction of Probiotics and Bacterial Replacement Therapy. The term probiotic is derived from the Greek, meaning "for life" are microorganisms proven to exert health promoting influences in humans and animals. Food and Agriculture Organization and WHO have stated that there is potential for probiotic foods to provide health benefits and that specific strains are safe for human use.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Inersan | Experimental | Drug: InersanInersan - 2 Lozenges daily (one lozenge in morning and one lozenge in night) for 2 weeks. Each lozenge contains at least 1 billion CFU of Lactobacillus brevis CD2. |
| Inersan and Doxycycline together | Experimental | Drug: Inersan, Drug: DoxycyclineDoxycycline: 1 Tablet once daily (in afternoon) for 2 weeks. Each tablet contains 100 mg Doxycycline. Inersan - 2 Lozenges daily (one lozenge in morning and one lozenge in night) for 2 weeks. Each lozenge contains at least 1 billion CFU of Lactobacillus brevis CD2. |
| Doxycycline | Active comparator | Drug: DoxycyclineDoxycycline: 1 Tablet once daily (in afternoon) for 2 weeks. Each tablet contains 100 mg Doxycycline. |
Who may qualify
- Ages
- 25 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Subjects in both sexes
- Age 25 - 60 yrs
- Subjects with mild to moderate chronic periodontitis, as defined by probing pocket depths ≥ 5mm in > 30 % of the probing sites
- Subjects in good general health
Key exclusion criteria (6 listed)
- Antibiotic therapy in the past 2 months
- Allergic to doxycycline or probiotics
- Subjects with diabetic mellitus, hypertension and psychiatric disorders
- Subjects who are pregnant/ lactating
- Smokers and/or alcoholics
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 |
|---|---|---|
| InersanAlso: Each lozenge contains not less than 1 billion CFU of Lactobacillus brevis CD2Probiotic | Drug | Inersan, Inersan and Doxycycline together |
| DoxycyclineAlso: Each tablet contains 100 mg of DoxycyclineAntibiotic | Drug | Doxycycline, Inersan and Doxycycline together |
Primary outcome
Improvement in periodontal clinical indices
Time frame: 4 weeks
Improvement in periodontal clinical indices, namely, Gingival Index (GI), Probing Pocket Depth (PPD), Plaque Index (PI) and Clinical Attachment level (CAL)
1 secondary outcome
Improvement in microbiological indices
Time frame: 4 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 15 Dec 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.
Arya K.S., BDS principal investigator
Sree Mookambika Institute of Dental Sciences
Elizabeth Koshi, MDS study director
Sree Mookambika Institute of Dental Sciences
Arun Sadasivan, MDS principal investigator
Sree Mookambika Institute of Dental Sciences
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 Inersan and Doxycycline 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 4 inclusion and 6 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 15 Dec 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. 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: 4 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 15 Dec 2014.