| 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
|
|
|
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
|
|
|
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. |