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CTRI Number  CTRI/2025/07/090133 [Registered on: 03/07/2025] Trial Registered Prospectively
Last Modified On: 03/07/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparing the effectiveness of remineralizing agents, Tooth Mousse and Toothmin on salivary pH and flow rate 
Scientific Title of Study   Comparative Evaluation of Two Remineralizing Agents on Salivary pH and Salivary Flow Rate – An in vivo study 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Vedashree Chaudhari 
Designation  Post Graduate Student 
Affiliation  Dr. D.Y. Patil Dental College and Hospital, Pimpri, Pune 
Address  F2/004, Success Towers, Panchavati, Pashan Road, Pune
Department of Pediatric and Preventive Dentistry, Dr. D.Y. Patil Dental College and Hospital, Sant Tukaram Nagar, Pimpri, Pune - 411018
Pune
MAHARASHTRA
411008
India 
Phone  7767813199  
Fax    
Email  vedashree1398@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Lalit Patil  
Designation  Associate Professor  
Affiliation  Dr. D.Y. Patil Dental College and Hospital, Pimpri, Pune 
Address  Dr. D.Y. Patil Dental College and Hospital, Sant Tukaram Nagar, Pimpri, Pune
Department of Pediatric and Preventive Dentistry, Dr. D.Y. Patil Dental College and Hospital, Sant Tukaram Nagar, Pimpri, Pune - 411018
Pune
MAHARASHTRA
411018
India 
Phone  9765370827  
Fax    
Email  drlalitpatil47@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Lalit Patil  
Designation  Associate Professor  
Affiliation  Dr. D.Y. Patil Dental College and Hospital, Pimpri, Pune 
Address  Dr. D.Y. Patil Dental College and Hospital, Sant Tukaram Nagar, Pimpri, Pune
Department of Pediatric and Preventive Dentistry, Dr. D.Y. Patil Dental College and Hospital, Sant Tukaram Nagar, Pimpri, Pune - 411018
Pune
MAHARASHTRA
411018
India 
Phone  9765370827  
Fax    
Email  drlalitpatil47@gmail.com  
 
Source of Monetary or Material Support  
Department of Pediatric and Preventive Dentistry, Dr. D.Y. Patil Dental College and Hospital, Sant Tukaram Nagar, Pimpri, Pune - 411018 
 
Primary Sponsor  
Name  Vedashree Chaudhari 
Address  F2-004, Success Towers, State Bank Nagar, Panchavati, Pashan Road, Pune- 411008, Maharashtra, India 
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 Lalit Patil  Dr. D. Y Patil Dental College and Hospital  Department number 8, Second floor, Department of Paediatric and Preventive Dentistry
Pune
MAHARASHTRA 
9765370827

drlalitpatil47@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Dr. D.Y. Patil Dental College and Hospital Institutional Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Children aged 6-9 years, with proper oral hygiene 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Tooth Mousse   The investigational products is Tooth Mousse. This product is known for its remineralization potential. This paste contains Casein Phosphopeptide-Amorphous Calcium Phosphate. The paste will be applied on all teeth using the investigators fingers for 3 minutes and then the patients will be asked to spit. 
Comparator Agent  Toothmin  The investigational products is Toothmin. This product is known for its remineralization potential. This paste contains Calcium Sucrose Phosphate. The paste will be applied on all teeth using the investigators fingers for 3 minutes and then the patients will be asked to spit. 
 
Inclusion Criteria  
Age From  6.00 Year(s)
Age To  9.00 Year(s)
Gender  Both 
Details  Children aged 6-9 years of age reporting to the Department of Pediatric and Preventive Dentistry as well as patients from organized school dental camps.
Participants should not have any dental caries (code 0 according to ICDAS-II).
Participants parents who give consent to participate in the study.
 
 
ExclusionCriteria 
Details  Any systemic disease that affect flow rate of saliva.
Patients undergoing orthodontic treatment.
Patients taking any antibiotics or any kind of medications past 1 month that can affect the salivary flow rate.
Patients having confirmed or suspected allergy to proteins.
Patients with special health care needs, calcium or phosphate deficiency.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
To evaluate and compare the Salivary pH and Salivary Flow Rate using Toothmin (Abbott) and GC Tooth Mousse.
 
6 months 
 
Secondary Outcome  
Outcome  TimePoints 
NA  NA 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
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)   15/07/2025 
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="6"
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  
Need for the study
Caries is defined as a process of enamel or dentin dissolution that is caused by microbial action at the tooth surface and is mediated by physiochemical flow of water dissolved ions(Ostrom, 1980). Saliva is a heterogenous liquid mainly composed of water and encompasses organic and inorganic constituents. It functions as a cleaning, lubricating, oral health maintaining and a buffering agent for the teeth and oral mucosa while also serving as a calcium and phosphate storage solution. The ions in the saliva remineralize initial carious lesions.2 Salivary pH and buffering capacity are crucial characteristics in managing the ion exchanges throughout the remineralization and demineralization of enamel. Normal salivary pH ranges from 6.2 to 7.6.2 The Casein Phosphopeptide-Amorphous Calcium Phosphate (CPP-ACP) complex derived from a milk protein- Casein has been reported to inhibit enamel demineralization by maintaining the supersaturation of calcium and phosphate in saliva, buffering of plaque pH and increasing the calcium and phosphate ion levels in plaque. Toothmin consists of a formula known as Anticay which aids in remineralization. Anticay is a mixture of calcium salts of sucrose phosphate esters, complexed with inorganic calcium phosphate. It is composed of 10-12% calcium and 8-10% phosphorous by weight.4 Thus, the aim of the study is intended to comparatively evaluate the effect of Two Remineralizing Agents : Toothmin and GC Tooth Mousse on Salivary pH and Salivary Flow Rate.

Aim of Study: To evaluate and compare the effect of Two Remineralizing Agents: Toothmin(Abbott) and GC Tooth Mousse on Salivary pH and Salivary Flow Rate.

Objectives of this study: 
 
1. To evaluate the Salivary pH using Toothmin (Abbott) and GC Tooth Mousse.
2. To evaluate the Salivary Flow Rate using Toothmin (Abbott) and GC Tooth Mousse
3. To compare the Salivary pH and Salivary Flow Rate using Toothmin (Abbott) and GC Tooth Mousse.

Source of data
Type of study – Randomized Clinical Trial
In-vitro/in-vivo/survey – In – vivo study
Source from where the cases, patients, subjects, or study material will be selected- 
Patient reporting on OPD as well as patients from organized school dental camps by the Dept of Pediatric and Preventive Dentistry, Dr. D.Y Patil Dental College and Hospital, Pimpri, Pune.
Name and place where the study will be conducted- Dept of Pediatric and Preventive Dentistry, Dr. D. Y Patil Dental College and Hospital, Pimpri, Pune.

Method of data collection 
Sampling technique used – Simple Random Sampling 
Sample size – 40
Size of each group: 20
Group I: Toothmin
Group II: GC Tooth Mousse

Inclusion criteria: 1. Children 6-9 years of age. 2. Participants should not have any dental caries (code 0 according to ICDAS-II). 3. Participants parents who give consent to participate in the study.
Exclusion criteria: 1. Any systemic disease that affect flow rate of saliva. 2. Patients undergoing orthodontic treatment. 3. Patients taking any antibiotics or any kind of medications past 1 month that can affect the salivary flow rate. 4. Patients having confirmed or suspected allergy to proteins. 5. Patients with special health care needs, calcium or phosphate deficiency.

MATERIALS:  

Calcium Sucrose Phosphate (Toothmin, Abbott)
Casein Phosphopeptide-Amorphous Calcium Phosphate (GC Tooth Mousse)
Paraffin wax

INSTRUMENTS:

Diagnostic instruments 
Graduated test tubes
pH meter, calibration done with buffer powder as per manufacturing instructions (IONIX)

ARMAMENTERIUM:

Mouth mask, Head cap
Gloves

Procedure:
Patients will be selected according to the inclusion and exclusion criteria. The study procedure will be explained to each participant’s parents and necessary informed consent from the parent/guardian and assent from the child will be obtained in a language that they understand. Patients will be divided into two groups randomly by computer generated random numbers.
Group 1: Tooth Mousse N = 20    Group 2: GC Toothmin N = 20
Patients will be asked not to eat or drink anything for 2 hours before collecting salivary sample. Salivary samples will be collected from the patients between 10am-12pm. Children will be given sugar-free gums to chew for a period of 3 minutes under operator’s supervision and later drooled saliva will be collected into saliva collecting tube. Toothmin (Abbott) and GC Tooth Mousse will be applied after salivary sample collection. 
The salivary sample collection process will be done 4 times: before the application of the agents to be studied(T0), immediately after the application of the agents(T1), after half an hour(T2) and after an hour(T3). pH of the saliva will be measured in each point of time using calibrated pH meter. The amount of saliva collected will be calculated and divided by 3 to report the amount of saliva collected per minute(ml/min). Data will be recorded and tabulated and results will be analyzed using statistical analysis method.

Method of data analysis:  
Unpaired t- test
Repeated measures ANOVA with post-hoc test
 
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