| CTRI Number |
CTRI/2025/10/096331 [Registered on: 22/10/2025] Trial Registered Prospectively |
| Last Modified On: |
21/10/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Probiotic
Dentistry |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
A study to test if the probiotic Lactobacillus paracasei GMNL-33 can improve gum health in people receiving regular treatment for gum disease |
|
Scientific Title of Study
|
Evaluation of the efficacy of L. paracasei GMNL-33 as an effective adjunct in periodontal therapy |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr PSG PRAKASH |
| Designation |
Professor |
| Affiliation |
SRM DENTAL COLLEGE,Ramapuram campus |
| Address |
Department Of Periodontics, 3rd Floor PG Block, PG Clinic, SRM Dental College, Bharathi Salai, Ramapuram, Chennai.
Chennai-600089,
TAMIL NADU,
India.
SRM Dental College, Bharathi Salai, Ramapuram, Chennai.
Chennai-600089,
TAMIL NADU,
India.
Chennai
TAMIL NADU
600089
India |
| Phone |
9840870990 |
| Fax |
|
| Email |
akashpsg@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr PSG PRAKASH |
| Designation |
Professor |
| Affiliation |
SRM DENTAL COLLEGE,Ramapuram campus |
| Address |
Department Of Periodontics, 3rd Floor PG Block, PG Clinic, SRM Dental College, Bharathi Salai, Ramapuram, Chennai.
Chennai-600089,
TAMIL NADU,
India.
SRM Dental College, Bharathi Salai, Ramapuram, Chennai.
Chennai-600089,
TAMIL NADU,
India.
Chennai
TAMIL NADU
600089
India |
| Phone |
9840870990 |
| Fax |
|
| Email |
akashpsg@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr PSG PRAKASH |
| Designation |
Professor |
| Affiliation |
SRM DENTAL COLLEGE,Ramapuram campus |
| Address |
Department Of Periodontics, 3rd Floor PG Block, PG Clinic, SRM Dental College, Bharathi Salai, Ramapuram, Chennai.
Chennai-600089,
TAMIL NADU,
India.
SRM Dental College, Bharathi Salai, Ramapuram, Chennai.
Chennai-600089,
TAMIL NADU,
India.
Chennai
TAMIL NADU
600089
India |
| Phone |
9840870990 |
| Fax |
|
| Email |
akashpsg@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of periodontics,
SRM Dental College, Bharathi Salai, Ramapuram, Chennai.
Chennai-600089,
TAMIL NADU,
India. |
|
|
Primary Sponsor
|
| Name |
Dr PSG Prakash Self |
| Address |
SRM Dental College, Bharathi Salai, Ramapuram, Chennai.
Chennai-600089,
TAMIL NADU,
India. |
| Type of Sponsor |
Research institution |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr PSG Prakash |
outpatient department SRM dental college |
Department of periodontics, SRM Dental College, Ramapuram Campus, Chennai- 600089
Chennai
TAMIL NADU |
9840870990
akashpsg@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL REVIEW BOARD SRM DENTAL COLLEGE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K053||Chronic periodontitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
L paracasei GMNL 33 |
probiotic supplements sporlac DG mouth dissolving tablets containing heat killed Lactobacillus paracaesi GMNL-33 oral tablet once after dinner |
| Comparator Agent |
placebo |
placebo for SPORLAC DG -probiotic supplement once after dinner |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
INCLUSION CRITERIA:
1. Systemically healthy patients of age 30 to 60 are to be recruited for the study
Gingivitis patients with presence of bleeding on probing with no attachment loss
2.Stage 1 and 2 periodontitis patients presenting with PPD greater than 4 mm with CAL greater than 4mm in atleast 30 percentage of the teeth
3 periodontitis patients presenting with PPD greater than 5mm with CAL greater than 5mm in atleast 30 percent of the teeth
|
|
| ExclusionCriteria |
| Details |
1. Patients with any inflammatory systemic conditions such as diabetes mellitus, rheumatoid arthritis, etc.
2. Patients with immunodeficiency disorders.
3. Patients with local modifiers like food impaction, factitious habits and bruxism.
4. Patients who smoke.
5. Use of orthodontic and prosthetic appliances.
6.Patients who had taken systemic antibiotic, antiinflammatory, hormonal or other assisted drug therapy in the last 6 months or prior to the study.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Double Blind Double Dummy |
|
Primary Outcome
|
| Outcome |
TimePoints |
PRIMARY OBJECTIVE:
The primary outcomes of the trial were changes in CAL and PPD in periodontitis group ,percentage (%) of gingival sites with bleeding on probing BOPIn Gingivitis group
|
2 months and 6 months
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
SECONDARY OBJECTIVE:
The secondary outcomes were to evaluate the microbial colonization of P gingivalis, T denticola and T forsythia and biochemical parameters the changes in the proinflammatory markers 1L1beta ,IL6,TNFalpha and antiinflammatory markers like 1L10. Additionally, halitosis will be evaluated as a clinical parameter. Patients to be assessed for quality of life using OHIP 14 questionaarie) at baseline, 30 days and 60 days for both the groups to determine the overall impact of treatment on their well being.
|
2months and 6 months |
|
|
Target Sample Size
|
Total Sample Size="144"
Sample Size from India="144"
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 4 |
|
Date of First Enrollment (India)
|
01/11/2025 |
| 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="0"
Months="8"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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 characterized by the progressive destruction of the tooth-supporting structures, triggered by a dysbiotic microbial biofilm and an exaggerated host immune response. Conventional periodontal therapy focuses on mechanical plaque control and, at times, antimicrobial use; however, limitations such as antibiotic resistance and inconsistent long-term outcomes have encouraged exploration of adjunctive approaches. Probiotics have gained significant interest due to their ability to restore microbial balance, inhibit pathogens, and modulate immune responses, offering a biological means to enhance periodontal healing. Among various probiotic strains, Lactobacillus paracasei has shown strong antimicrobial and anticandidal activity against several oral pathogens. Nevertheless, the specific strain L. paracasei GMNL-33 remains relatively unexplored despite evidence suggesting its immunomodulatory and antimicrobial potential. Therefore, this study aims to evaluate the clinical, microbiological, and biochemical efficacy of L. paracasei GMNL-33 as an adjunct in the management of gingivitis and periodontitis, potentially offering a safe and effective probiotic-based approach to improve periodontal health. |