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CTRI Number  CTRI/2025/02/080488 [Registered on: 13/02/2025] Trial Registered Prospectively
Last Modified On: 29/01/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   Comparison of Salivary pH Flow rate and Oral Clearance rate Between Four Different Vegan Milk in Young Adults 
Scientific Title of Study   Comparative Evaluation of Salivary pH Flow rate and Oral Clearance rate Between Four Different Vegan Milk in Young Adults AN IN- VIVO CONTROLLED TRAIL 
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 Saloni Wankhede 
Designation  PG Student  
Affiliation  JMFs ACPM Dental College Dhule 
Address  Department of Public Health dentistry Room no 8 third floor Jawahar Medical Foundation Annasaheb Chudaman Patil Memorial Dental College Dhule Dhule MAHARASHTRA 424001 India

Dhule
MAHARASHTRA
424001
India 
Phone  9307139321  
Fax    
Email  saloniwankhede9096@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Prashanth Vishwakarma 
Designation  Professor 
Affiliation  JMFs ACPM Dental College Dhule 
Address  Department of Public health dentistry Room no 8 third floor Jawahar Medical Foundation Annasaheb Chudaman Patil Memorial Dental College Dhule Dhule MAHARASHTRA 424001 India

Dhule
MAHARASHTRA
424001
India 
Phone  9766745627  
Fax    
Email  dr_prashanthvk@yahoo.com  
 
Details of Contact Person
Public Query
 
Name  Dr Saloni Wankhede 
Designation  PG Student  
Affiliation  JMFs ACPM Dental College Dhule 
Address  Department of Public health dentistry Room no 8 third floor Jawahar Medical Foundation Annasaheb Chudaman Patil Memorial Dental College Dhule Dhule MAHARASHTRA 424001 India

Dhule
MAHARASHTRA
424001
India 
Phone  9307139321  
Fax    
Email  saloniwankhede9096@gmail.com  
 
Source of Monetary or Material Support  
JMFs ACPM Dental College dhule maharashtra India pin code 424001 
 
Primary Sponsor  
Name  Dr. Saloni Wankhede 
Address  JMFs ACPM Dental College Dhule Maharashtra India Pincode 424001 
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 Saloni Wankhede  Jawahar medical foundation annasaheb chudaman patil memorial dental college  Departement OF Public Health Dentistry Room NO 8 Third Floor awaharal medical foundation annasaheb chudaman patil memorial dental college dhule
Dhule
MAHARASHTRA 
9307139321

saloniwankhede9096@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Annasaheb Chaudam Patil Memorial Institutional ethical committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  NA 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  almond milk  At the baseline and after 10 min 15 min and 30 min the intrinsic pH salivary flow rate and oral clearance rate will be measured  
Comparator Agent  cashew milk   At the baseline and after 10 min 15 min and 30 min the intrinsic pH salivary flow rate and oral clearance rate will be measured 
Comparator Agent  coconut milk  At the baseline and after 10 min 15 min and 30 min the intrinsic pH salivary flow rate and oral clearance rate will be measured 
Comparator Agent  soy milk  At the baseline and after 10 min 15 min and 30 min the intrinsic pH salivary flow rate and oral clearance rate will be measured 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  30.00 Year(s)
Gender  Both 
Details  Subjects who were above 18 years of age
Subjects who were caries-free, that is, with DMFT score 0
Subjects who were not suffering from any systemic disease or illness
 
 
ExclusionCriteria 
Details  Subjects who did not give informed consent.
Subjects who were using alcohol or tobacco in any form.
Subjects who were using any medication at the time of study or in the period of the last 15 days prior to the study.
Participants allergic to different milk.

 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Alternation 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To evaluate The salivary pH
Salivary flow rate Oral clearance rate of different vegan milk in young adults.
 
10min 15 min 30 min after consumption of test food 
 
Secondary Outcome  
Outcome  TimePoints 
To compare The salivary pH
Salivary flow rate
Oral clearance rate of different vegan milk in young adults.
 
10min 15 min 30 min after consumption of test food 
 
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   Phase 3 
Date of First Enrollment (India)   27/02/2025 
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="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
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  

Comparative evaluation of salivary ph, flow rate and oral clearance rate between four different vegan milk in young adults: an in- vivo controlled trail

 

Abstarct : It is well established that a good diet is essential for the development and maintenance of healthy teeth. Diet is a major etiological factor for dental caries and enamel erosion. The normal pH of saliva is 6.7 to 7.4. When the pH level in mouth goes below 5.5 (i.e., the critical pH value), the acids begin to break down the enamel on teeth. The longer the teeth are exposed to a low salivary pH, the more likely the development of dental caries.The rise in popularity of vegan milk alternatives is driven by a growing concern for health and ethical considerations associated with traditional dairy products. These alternatives, sourced from plants like soy, almond, oat, coconut, and rice, offer various nutritional advantages. They typically contain lower levels of cholesterol, lactose, and saturated fats compared to cow’s milk.Hence, the following study was undertaken with the aim of assessing the effect of four different vegan milk on salivary pH, flow rate, and oral clearance rate amongst young adults.It is an in vivo controlled trial conducted in department of public health dentistry. The study was conducted among 60 participants aged between 18-25 years randomly divided into 4 groups each group containing 15 participants. Unstimulated salivary sample will be collected for each study subject at least one hour after their breakfast. After the collection of baseline salivary samples the subjects will be given vegan milk to drink and then unstimulated saliva samples will be collected at 5,10,15,30 minute time intervals. At the baseline, the intrinsic pH of each milk will be measured. Data Input in Excel sheet.Data will be analyzed using SPSS software v23. The level of significance will be kept at 5%. Data will be tested for normality using the Shapiro-Wilk test. Intragroup comparison of the variables will be done using either repeated measures ANOVA test or Friedman two-way ANOVA test followed by Bonferroni test for pairwise comparisons. Intergroup comparison of the variables at each interval will be done using either the independent t test or the mann whitney test.

 
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