| CTRI Number |
CTRI/2009/091/000006 [Registered on: 13/01/2009] |
| Last Modified On: |
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| Post Graduate Thesis |
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| Type of Trial |
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Type of Study
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| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
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Public Title of Study
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A clinical trial to study the efficacy of probiotic Lactobacillus brevis lozenges in patients with chronic periodontitis |
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Scientific Title of Study
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A randomized, double blind, placebo controlled study of efficacy of Lactobacillus CD2 lozenges in patients with chronic periodontitis |
| Trial Acronym |
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Secondary IDs if Any
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| Secondary ID |
Identifier |
| NIL |
NIL |
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
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| Name |
Dr. Ajoy Roychoudhury |
| Designation |
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| Affiliation |
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| Address |
Dr. Ajoy Roychoudhury, Room No.111,Center for Dental Education and Research
New Delhi
DELHI
110029
India |
| Phone |
9891007749, 011-26589303 |
| Fax |
011-26589303 |
| Email |
ajoyroy@hotmail.com |
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Details of Contact Person
Scientific Query
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| Name |
Dr. Ajoy Roychoudhury |
| Designation |
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| Affiliation |
AIIMS |
| Address |
Dr. Ajoy Roychoudhury, Room No.111,Center for Dental Education and Research
New Delhi
DELHI
110029
India |
| Phone |
9891007749, 011-26589303 |
| Fax |
011-26589303 |
| Email |
ajoyroy@hotmail.com |
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Details of Contact Person
Public Query
|
| Name |
Dr. Ajoy Roychoudhury |
| Designation |
|
| Affiliation |
|
| Address |
Dr. Ajoy Roychoudhury, Room No.111,Center for Dental Education and Research
New Delhi
DELHI
110029
India |
| Phone |
9891007749, 011-26589303 |
| Fax |
011-26589303 |
| Email |
ajoyroy@hotmail.com |
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Source of Monetary or Material Support
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| CD Pharma India Pvt. Ltd. C 1/53, Ist floor, SDA, New Delhi-110016, Tel.01141759898, Fax. 0114175989 |
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Primary Sponsor
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| Name |
CD Pharma India Pvt. Ltd. C 1/53, Ist floor, SDA, New Delhi-110016, Tel.01141759898, Fax. 0114175989 |
| Address |
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| Type of Sponsor |
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Details of Secondary Sponsor
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Countries of Recruitment
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India |
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Sites of Study
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| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr. Ajoy Roychoudhury |
Center for Dental Education and Research |
Dr. Ajoy Roychoudhary, Room No.111,Center for Dental Education and Research ,-110029
New Delhi
DELHI |
9891007749, 011-26589303
011-26589303
ajoyroy@hotmail.com |
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Details of Ethics Committee
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| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee of All India Institute of Medical Sciences, New Delhi-110029 |
Approved |
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Regulatory Clearance Status from DCGI
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Health Condition / Problems Studied
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| Health Type |
Condition |
| Patients |
Chronic periodontitis, |
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Intervention / Comparator Agent
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| Type |
Name |
Details |
| Intervention |
Lactobacillus CD2 lozenges |
6 lozenges per day for 8 weeks |
| Comparator Agent |
Placebo |
6 lozenges per day for 8 weeks |
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Inclusion Criteria
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| Age From |
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| Age To |
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| Gender |
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| Details |
Inclusion Criteria
1.Patients between 20-50 yrs of age groups.
2.Patients with chronic periodontitis with or without accompanying systemic conditions.
3.The patient should have at least 20 fully erupted teeth.
4.Patient agreeing to strictly follow study instructions and doctor?s advice for sucking the lozenges.
5.Patients ready to give written informed consent for participating in the trial.
6.Patients agreeing to comply with the study protocol and instructions.
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| ExclusionCriteria |
| Details |
Exclusion Criteria
1.Pregnant women and lactating mothers.
2.Has a debilitating systemic disease or disease that affects the periodontium.
3.Needs prophylactic antibodies.
4.Patients treated with antibiotic within 30 days prior to beginning of the study.
5.Is already a part of any other clinical trial or has taken any other investigational drug in the last 30 days.
6.Patient having active periapical abscess or periodontal abscess or a history of acute necrotizing ulcerative gingivitis.
7.Patients not willing to participate in the trial.
8.Patients with psychiatric disorders.
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Method of Generating Random Sequence
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Computer generated randomization |
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Method of Concealment
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Sequentially numbered, sealed, opaque envelopes |
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Blinding/Masking
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Participant, Investigator and Outcome Assessor Blinded |
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Primary Outcome
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| Outcome |
TimePoints |
| 1.Reduction in Community Periodontal Index (CPI) 2.Reduction in Sulcus bleeding Index (SBI)
3.Reduction in Plaque Index (PI)
4.Reduction in Gingival Index (GI)
5.Cessation of pus formation.
6.Improvement in clinical photograph at the time of recruitment and at the end of the study.
7.Reduction of clinically detectable plaque to a level compatible with periodontal health.
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1.Reduction in Community Periodontal Index (CPI) 2.Reduction in Sulcus bleeding Index (SBI)
3.Reduction in Plaque Index (PI)
4.Reduction in Gingival Index (GI)
5.Cessation of pus formation.
7.Reduction of clinically detectable plaque to a level compatible with periodontal health.
Timepoint- At baseline, after 4 weeks and end of the study (Total study Duration-8 weeks)
6.Improvement in clinical photograph at the time of recruitment and at the end of the study
Timepoint- Baseline and after 8 weeks (at end of the study) |
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Secondary Outcome
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| Outcome |
TimePoints |
| 1.Comparison of the levels of Matrixmetalloproteinases (MMPs), Nitric oxide Synthase (NOS) activity, IgA antibodies, Prostaglandin E2 (PGE2), cytokines levels (IL-1, IL-6, IL-8, TNF-α, IFN-γ) in saliva and crevicular fluid samples
2.Comparison of Quality of life (QoL) in test and control group
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1. Comparison of the levels of Matrixmetalloproteinases (MMPs), Nitric oxide Synthase (NOS) activity, IgA antibodies, Prostaglandin E2 (PGE2), cytokines levels (IL-1, IL-6, IL-8, TNF-α, IFN-γ) in saliva and crevicular fluid samples
Timepoint- At baseline, and end of the study (after 8 weeks)
2.Comparison of Quality of life (QoL) in test and control group
Timepoint-At baseline, after 4 weeks and end of the study (Total study Duration-8 weeks) |
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Target Sample Size
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Total Sample Size="150"
Sample Size from India=""
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
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Phase of Trial
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Phase 2/ Phase 3 |
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Date of First Enrollment (India)
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Date Missing |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
14/02/2007 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
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Estimated Duration of Trial
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Years="2"
Months="0"
Days="0" |
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Recruitment Status of Trial (Global)
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Completed |
| Recruitment Status of Trial (India) |
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Publication Details
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Individual Participant Data (IPD) Sharing Statement
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Will individual participant data (IPD) be shared publicly (including data dictionaries)?
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Brief Summary
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This study is a randomized, double blind, parallel group, single-centre trial to study the efficacy of the probiotic Lactobacillus CD2 Lozenges (INERSAN) in chronic periodontitis patients.The primary endpoints are reduction in Community Periodontal Index (CPI), Reduction in Sulcus bleeding Index (SBI),Reduction in Plaque Index (PI),Reduction in Gingival Index (GI),Cessation of pus formatioImprovement in clinical photograph at the time of recruitment and at the end of the study and Reduction of clinically detectable plaque to a level compatible with periodontal health. The secondary endponts are Comparison of the levels of Matrixmetalloproteinases (MMPs), Nitric oxide Synthase (NOS) activity, IgA antibodies, Prostaglandin E2 (PGE2), cytokines levels (IL-1, IL-6, IL-8, TNF-α, IFN-γ) in saliva and crevicular fluid samples and Comparison of Quality of life (QoL) in test and control group.
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