| 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
|
|
|
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. | |