FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2025/03/083180 [Registered on: 24/03/2025] Trial Registered Prospectively
Last Modified On: 25/02/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Probiotic 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Probiotic Therapy in Diabetes Patients With Periodontitis 
Scientific Title of Study   Probiotic Therapy as an Adjunct Treatment in Periodontitis Patients with Type 2 Diabetes Mellitus: A Randomized Controlled Clinical Trial 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Divya ManojBhai Rathi 
Designation  Post-Graduate Student 
Affiliation  Ahmedabad Dental College and Hospital 
Address  Department of Periodontology Ahmedabad Dental College and Hospital Gandhinagar

Gandhinagar
GUJARAT
382115
India 
Phone  7069886869  
Fax    
Email  rathidivya777@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Chaitali Agarwal, Dr Mishal Shah 
Designation  Professor 
Affiliation  Ahmedabad Dental College and Hospital 
Address  Department of Periodontology Ahmedabad Dental College and Hospital Gandhinagar

Gandhinagar
GUJARAT
382115
India 
Phone  9913602125, 9909218929  
Fax    
Email  drmishalshah@yahoo.com  
 
Details of Contact Person
Public Query
 
Name  Divya ManojBhai Rathi 
Designation  Post-Graduate Student 
Affiliation  Ahmedabad Dental College and Hospital 
Address  Department of Periodontology Ahmedabad Dental College and Hospital GANDHINAGAR

Gandhinagar
GUJARAT
382115
India 
Phone  7069886869  
Fax    
Email  rathidivya777@gmail.com  
 
Source of Monetary or Material Support  
Department of Periodontology, Ahmedabad Dental College and Hospital, Gandhinagar-382115 
 
Primary Sponsor  
Name  Department of Periodontology Ahmedabad Dental College and Hospital 
Address  Gandhinagar-382115 Gujarat, India 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
Next Gen Pharma India Pvt Ltd  House # 331, First Floor Sector 15A, Noida 201301 Uttar Pradesh 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Divya ManojBhai Rathi  Ahmedabad Dental College and Hospital  Department of Periodontology, Ahmedabad Dental College and Hospital, Gandhinagar-382115
Gandhinagar
GUJARAT 
7069886869

rathidivya777@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committe, Ahmedabad Dental Collegee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K056||Periodontal disease, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Placebo (contains all ingredients except the probiotic bacteria)  1 tablet BD for 14 days 
Intervention  Probiotic Tablet (Orabiome) - Each tablet contains 1 billion cfu of levilactobacillus brevis CD2  1 tablet BD for 14 days 
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1) Patients with Type 2 Diabetes Mellitus and HbA1c more than 7.
3) Moderate to severe periodontal disease.
4) Probing depth more than 4mm.
5) Patients who can provide informed consent.
 
 
ExclusionCriteria 
Details  1) Pregnancy or lactating women.
2) Patients who have taken antibiotics within last 3 months.
3) Patients with known allergy to probiotics or to tablet contents.
4) Patients who have received periodontal therapy in past 6 months.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded 
Primary Outcome  
Outcome  TimePoints 
Clinical parameters (Gingival Index, Plaque Index, Probing Pocket Depth, Clinical Attachment Level)   Baseline, 1 month and 3 months 
 
Secondary Outcome  
Outcome  TimePoints 
1) Clinical Parameters - HbA1c and PPBS
2) Microbiological assessment of gram negative pathogens  
Baseline, 1 month and 3 months 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 3/ Phase 4 
Date of First Enrollment (India)   01/05/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

Periodontitis is a chronic inflammatory disease that affects the supporting structures of the teeth, leading to tissue destruction and potential tooth loss. It is a significant public health concern, particularly in individuals with Type 2 diabetes mellitus (T2DM), as diabetes exacerbates the progression of periodontal disease due to impaired immune responses and delayed wound healing.1

Diabetic patients often exhibit poor response to conventional periodontal treatments, such as scaling and root planing (SRP), which remain the standard approach for managing periodontitis.2 Despite this, many diabetic patients experience recurrent or persistent periodontal breakdown, necessitating the exploration of adjunctive therapies. In recent years, there has been growing interest in the use of probiotics as a supplementary treatment for periodontal diseases. Probiotics have demonstrated potential benefits in modulating the inflammatory response, improving oral health, and reducing pathogenic bacteria in the oral cavity.3

Several studies have shown that probiotic therapy can help lower inflammatory cytokines, such as interleukin-4, which are implicated in the development of periodontitis.4Additionally, probiotics have been suggested to improve glycemic control in diabetic patients, which may, in turn, enhance periodontal health outcomes.5

The study will evaluate use of adjunct probiotics with SRP on clinical outcomes contributing to evidence supporting probiotics in diabetic periodontal care and improved glycemic control.

 
Close