| CTRI Number |
CTRI/2026/03/105294 [Registered on: 03/03/2026] Trial Registered Prospectively |
| Last Modified On: |
03/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Probiotic |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Can Fermented Rice Water and Probiotic Curd Improve saliva health in School Children Aged 5–12? |
|
Scientific Title of Study
|
Effect of Fermented Rice Water(FRW) and Probiotic
curd on salivary pH in 5–12-year-old children – A Randomized Controlled 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 |
Dr Isha Shahapurkar |
| Designation |
Post Graduate Resident |
| Affiliation |
Government Dental College Kottayam |
| Address |
Department of Pediatric and Preventive Dentistry, Block A.
Kottayam
KERALA
686008
India |
| Phone |
07875405001 |
| Fax |
|
| Email |
shahapurkarisha@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Gibi Syriac |
| Designation |
Assistant Professor |
| Affiliation |
Government Dental College Kottayam |
| Address |
Department of Pediatric and Preventive Dentistry, Block A
Kottayam
KERALA
686008
India |
| Phone |
9495937998 |
| Fax |
|
| Email |
drgibisyriac@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Isha Shahapurkar |
| Designation |
Post Graduate Resident |
| Affiliation |
Government Dental College Kottayam |
| Address |
Department of Pediatric and Preventive Dentistry, Block A
Kottayam
KERALA
686008
India |
| Phone |
07875405001 |
| Fax |
|
| Email |
shahapurkarisha@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Dental College, Gandhinagar P O, Kottayam, Kerala, India - 686008 |
|
|
Primary Sponsor
|
| Name |
Dr Isha Shahapurkar |
| Address |
Department of Pediatric and Preventive Dentistry, Block A, Government Dental College, Gandhinagar P O, Kottayam, Kerala, 686008 |
| Type of Sponsor |
Other [Self] |
|
|
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 |
| Isha Shahapurkar |
Government Dental College Kottayam |
Department of Pediatric and Preventive Dentistry, Block A
Kottayam
KERALA |
07875405001
shahapurkarisha@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| InstitutionalEthicsCommittee(IEC)/InstitutionalBoardReview(IRB) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Dental Caries |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Fermented Rice Water |
Preparation is by mixing two spoons of cooked rice and mixing with 100ml of water and storing in mud pot overnight.
Freshly overnight prepared
5ml of the Fermented Rice Water will be given once a day in the morning before any meal for squishing for 5 minutes followed by spitting it for 15 days. No consumption of the intervention, only squishing and spitting will be done after brushing before having any food. |
| Comparator Agent |
Probiotic Curd |
Market Available Probiotic curd (eg. Milky mist probiotic curd) will be provided to the participants. Parents will be instructed to give children 5ml of the probiotic curd. Children will be instructed to squish and spit the curd for 5 minutes daily for 15 days after brushing before having any food. Children will be instructed to spit and not consume the curd. |
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
Children who give assent to participate in the study and whose parents give written informed consent.
Healthy children without any Developmental Abnormalities or Medical Condition.
|
|
| ExclusionCriteria |
| Details |
Children with a history of taking any antibiotic treatment 1 month prior to the study period and throughout the study period
Children on any other supplements containing probiotics during the study.
Lactose intolerant subjects
Children on use of xylitol products for 3 weeks before and throughout the study.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Difference in change in salivary pH before and after use of Fermented Rice water and Probiotic curd. |
Baseline sample - before intervention
First Day Post Intervention Sample
Post Intervention Sample at 15th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To evaluate & compare changes in the selected salivary parameters before & after swishing & spitting of Fermented Rice Water & Probiotic Curd –
Buffering Capacity using Ericson’s method & Digital pH meter
Calcium content using Spectrophotometry method (NM-BAPTA as a chelating agent)
Phosphate content using Spectrophotometry method (Molybdate as a chelating agent)
|
Baseline sample - before intervention
First Day Post Intervention Sample
Post Intervention Sample at 15th day |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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
|
N/A |
|
Date of First Enrollment (India)
|
05/04/2026 |
| 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="0"
Months="3"
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 - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response - Proposals should be directed to [shahapurkarisha@gmail.com].
- For how long will this data be available start date provided 02-06-2026 and end date provided 25-11-1970?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Early childhood dental caries remains a major public health concern, with salivary pH playing a crucial role in the initiation and progression of the caries process. Natural, diet-based preventive strategies such as probiotics and fermented foods have gained attention due to their ability to modulate the oral microbiome and maintain salivary pH balance. Fermented rice water (FRW) and probiotic curd (PC) are traditional, cost-effective dietary products commonly consumed in Indian households and are known to possess probiotic properties. The present study is a randomized controlled trial designed to evaluate and compare the effect of fermented rice water and probiotic curd on salivary pH in children aged 5–12 years. Eligible participants will be randomly allocated into three groups: Group I (fermented rice water), Group II (probiotic curd), and Group III (control group). Baseline salivary pH will be recorded, followed by intervention-specific administration for a defined period, after which post-intervention salivary pH will be assessed. The primary outcome measure of the study is the change in salivary pH before and after the intervention. The findings of this study aim to provide scientific evidence regarding the role of traditional probiotic food products in maintaining oral pH and enhancing preventive strategies in pediatric dentistry. If proven effective, these easily accessible and economical dietary interventions could be incorporated into routine oral health promotion programs for children. |