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CTRI Number  CTRI/2025/03/083225 [Registered on: 24/03/2025] Trial Registered Prospectively
Last Modified On: 19/03/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Dentistry 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Comparison of the effect of Atropine on Saliva Flow in Patients undergoing dental treatment 
Scientific Title of Study   Comparative Evaluation of Reduction in Salivary Flow Rate by using Sublingual Atropine Sulphate Drops during Dental Treatment Procedure. 
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 Snehal Sunil Shinde 
Designation  Post graduate student  
Affiliation  Jawahar Medical Foundations Annasaheb Chudaman Patil Memorial Dental College , Dhule. 
Address  Department of Conservative Dentistry and Endodontics, Room No 4 ,2nd Floor, block no. b, Sakri road, Dhule tal. dist-Dhule Affiliated to MUHS Nashik.

Dhule
MAHARASHTRA
424001
India 
Phone  8830995112  
Fax    
Email  shindesnehal152@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Alisha Wani 
Designation  Reader 
Affiliation  Jawahar Medical Foundations Annasaheb Chudaman Patil Memorial Dental College , Dhule. 
Address  Department of Conservative Dentistry and Endodontics, Room No 4 ,2nd Floor, block no. b, Sakri road, Dhule tal. dist-Dhule Affiliated to MUHS Nashik.

Dhule
MAHARASHTRA
424001
India 
Phone  8788919851  
Fax    
Email  dralishabwani@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Snehal Sunil Shinde 
Designation  Post graduate student  
Affiliation  Jawahar Medical Foundations Annasaheb Chudaman Patil Memorial Dental College , Dhule. 
Address  Department of Conservative Dentistry and Endodontics, Room No 4 ,2nd Floor, block no. b, Sakri road, Dhule tal. dist-Dhule Affiliated to MUHS Nashik.

Dhule
MAHARASHTRA
424001
India 
Phone  8830995112  
Fax    
Email  shindesnehal152@gmail.com  
 
Source of Monetary or Material Support  
Jawahar medical foundations Annasaheb Chudaman Patil Memorial dental college,dhule Department of Conservative Dentistry and Endodontics, Room No 4,2nd Floor, block no. b,Sakri road, Dhule tal. dist-Dhule 424001. 
 
Primary Sponsor  
Name  Dr Snehal Sunil Shinde  
Address  Department of Conservative Dentistry and Endodontics, Room No 4,2nd Floor, block no. b,Annasaheb chudaman patil memorial dental college, Sakri road, Dhule tal. dist-Dhule Affiliated to MUHS Nashik.  
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 Snehal Sunil Shinde  jawahar medical foundations annasaheb chudaman patil memorial dental college,dhule  Department of Conservative Dentistry and Endodontics, Room No 4 ,2nd Floor, block no. b Sakri road, Dhule tal.dist-Dhule Affiliated to MUHS Nashik.
Dhule
MAHARASHTRA 		 08830995112

shindesnehal152@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, Reg. under NECRBHR, MoHFW, Govt of India - File No. - EC/NEW/INST/2022/2959  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K029||Dental caries, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Anticholinergic drug - atropine sulphate  atropine sulphate drops given sublingually by using dropper based on weight of the patient. given dose is 0.03mg/kg of body weight. 
Comparator Agent  Normal saline  normal saline drops given sublingually by using the dropper. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  45.00 Year(s)
Gender  Both 
Details  Patients without any systemic conditions.
All participants will be at least 18 years old, if a female non-pregnant and non-breastfeeding, and normotensive with no signs of heart disease.  
 
ExclusionCriteria 
Details  Patients with any systemic conditions
patients with allergy to atropine
patients with known kidney or liver impairment,anemic, treated with an anticholinergic medication  
 
Method of Generating Random Sequence   Stratified randomization 
Method of Concealment   Alternation 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Reduction in Salivary Flow Rate during Dental Treatment Procedure.   measurement of salivary flow at baseline,60 minutes and 90 minutes.  
 
Secondary Outcome  
Outcome  TimePoints 
change in systemic blood pressure,diastolic blood pressure and heart rate are the secondary outcomes.  time point are baseline ,60 minutes and 90 minutes.  
 
Target Sample Size   Total Sample Size="22"
Sample Size from India="22" 
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/ Phase 4 
Date of First Enrollment (India)   31/03/2025 
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="1"
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-identiļ¬cation.

  2. What additional supporting information will be shared?
    Response - Informed Consent Form

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  4. For what types of analyses will this data be available?
    Response - Any purpose.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [shindesnehal152@gmail.com].

  6. For how long will this data be available start date provided 01-04-2025 and end date provided 12-02-2030?
    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   This study  is a randomized,  double blind, parallel group clinical trial comparing the effect of sublingual atropine sulphate drops 0.03mg/kg  and Normal saline drops in reduction of salivary flow will be conducted in India. The study evaluates primary hypothesis as Are there any changes in salivary flow in the patients with normal salivary flow during dental procedures. 
    The primary outcome will compare and evaluate  the decrease in salivary flow at baseline , 60 minutes and 90 minutes. The secondary outcome  will measure  the heart rate , systolic and diastolic blood pressure at baseline ,60 minutes and 90 minutes.
 
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