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CTRI Number  CTRI/2026/04/108533 [Registered on: 16/04/2026] Trial Registered Prospectively
Last Modified On: 09/03/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Probiotic
Dentistry 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   After professional cleaning for gum disease, does probiotic (good bacteria) toothpaste or regular fluoride toothpaste work better in reducing harmful bacteria. 
Scientific Title of Study   Comparative effectiveness of probiotic toothpaste and fluoridated toothpaste as adjuncts to scaling and root planing on red complex bacteria in stage II periodontitis: A randomized controlled superiority trial in a tertiary care setting 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Anoop S 
Designation  Assistant Professor 
Affiliation  Government Dental College 
Address  Department of Periodontics, Government Dental College, Thiruvananthapuram, Kerala 695011

Thiruvananthapuram
KERALA
695011
India 
Phone  8891264263  
Fax    
Email  anoopperio@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Sreeraj Rajappan 
Designation  Associate Professor 
Affiliation  Government Dental College, Alappuzha 
Address  Department of Periodontics, Government Dental College, Vandanam, Alappuzha, Kerala

Alappuzha
KERALA
688005
India 
Phone  9400316183  
Fax    
Email  drsreeraj@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Anoop S 
Designation  Assistant Professor 
Affiliation  Government Dental College 
Address  Department of Periodontics, Government Dental College, Thiruvananthapuram, Kerala 695011


KERALA
695011
India 
Phone  8891264263  
Fax    
Email  anoopperio@gmail.com  
 
Source of Monetary or Material Support  
Government Dental College, Thiruvananthapuram 
 
Primary Sponsor  
Name  Dr Anoop S 
Address  Department of Periodontics, Government Dental College, Thiruvananthapuram, Kerala 695011 
Type of Sponsor  Other [self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Anoop S  Government Dental College  Department of Periodontics, Government Dental College, Thiruvananthapuram, Kerala 695011
Thiruvananthapuram
KERALA 		 8891264263

anoopperio@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, Government Dental College, Thiruvananthapuram  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K053||Chronic periodontitis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Probiotic toothpaste containing Bacillus coagulans (200 million CFU/gm)  Participants allocated to the intervention group will receive a commercially available probiotic toothpaste containing Bacillus coagulans (200 million CFU/gm). Following full-mouth scaling and root planing at baseline, participants will be instructed to brush twice daily (morning and evening) for 2 minutes using a standardized soft-bristled toothbrush and the Modified Bass technique. 1 inch length toothpaste will be used each time as per manufacturer recommendation for a duration of 1 month. Participants will be advised not to use any additional oral hygiene products (e.g., antimicrobial mouthwashes, other toothpastes, probiotics, or antibiotics) during the study period unless prescribed. Compliance will be assessed by weighing the toothpaste tubes at baseline and at the 1-month follow-up visit. 
Comparator Agent  Regular 1000 ppm Fluoridated Toothpaste  Participants allocated to the comparator group will receive a commercially available regular fluoridated toothpaste containing 1000 ppm fluoride. After full-mouth scaling and root planing at baseline, participants will be instructed to brush twice daily (morning and evening) for 2 minutes using a standardized soft-bristled toothbrush and the Modified Bass technique. A pea-sized amount of toothpaste will be used each time for a duration of 1 month. Participants will be advised not to use any additional oral hygiene products (e.g., antimicrobial mouthwashes, probiotic products, antibiotics, or other medicated toothpastes) during the study period unless prescribed. Compliance will be assessed by weighing the toothpaste tubes at baseline and at the 1-month follow-up visit. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Diagnosed with Stage II periodontitis based on 2017 World Workshop classification criteria

Presence of at least 20 natural teeth excluding third molars and teeth indicated for extraction

Moderate plaque levels at baseline

Willing to undergo scaling and root planing

Able and willing to provide written informed consent. 
 
ExclusionCriteria 
Details  Presence of systemic diseases affecting periodontal status (e.g., diabetes mellitus, immunosuppression, chronic kidney disease).

Pregnant or lactating women.

Current smokers or former smokers within the last 5 years.

Use of antibiotics, antimicrobials, long-term anti-inflammatory drugs, or immunosuppressants within the past 3 months.

History of allergy or hypersensitivity to any component of the study toothpastes.

Periodontal treatment within the last 6 months.

Regular consumption of probiotic supplements or probiotic-containing products within the last 3 months. 
 
Method of Generating Random Sequence   Permuted block randomization, fixed 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Proportion of participants achieving a negative result for red complex bacteria at 1 month following intervention, as assessed by the AMA DENT Point-of-Care (POC) test.

The outcome will be recorded as a binary variable (Positive/Negative) and compared between the probiotic toothpaste and fluoridated toothpaste groups. 		 baseline to 1 month 
 
Secondary Outcome  
Outcome  TimePoints 
Change in Gingival Index (GI) from baseline to 1 month.

Change in Plaque Index (PI) from baseline to 1 month.

Change in Bleeding on Probing percentage (BOP%) from baseline to 1 month.

Change in Probing Pocket Depth (PPD) from baseline to 1 month.

Patient-reported acceptability of the assigned toothpaste measured using a Likert-scale questionnaire at 1 month.

Cost-effectiveness outcomes (incremental cost per unit reduction in microbiological and clinical parameters) calculated at the end of the 1-month follow-up period. 		 Baseline to 1 month 
 
Target Sample Size   Total Sample Size="102"
Sample Size from India="102" 
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 
Date of First Enrollment (India)   27/04/2026 
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="0"
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 - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - For individual participant data meta-analysis.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [anoopperio@gmail.com].

  6. For how long will this data be available start date provided 01-12-2026 and end date provided 30-11-2031?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   Primary purpose of this protocol is to evaluate whether probiotic toothpaste containing Bacillus coagulans is superior to regular fluoridated toothpaste when used as an adjunct to scaling and root planing in patients with Stage II periodontitis. The study aims to determine if the probiotic toothpaste results in at least a 25 percentage point greater reduction in the proportion of participants testing negative for red complex bacteria after one month. The hypothesis is that probiotic toothpaste will produce a clinically significant improvement in microbiological and periodontal outcomes compared to fluoridated toothpaste. 
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