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CTRI Number  CTRI/2026/02/104395 [Registered on: 20/02/2026] Trial Registered Prospectively
Last Modified On: 19/02/2026
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A study to compare Lidocaine spray, acupressure and music with earplugs in 8 to 11 year old children during dental treatment to reduce gag reflex. 
Scientific Title of Study   Comparative Evaluation of Effectiveness of Topical lidocaine spray, Acupressure and Musical Earplug Temporal Tap Technique on Gag Reflex in 8-11 year old children- A Randomized Clinical 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  Dr Krushnapriya Gattani 
Designation  PG Student  
Affiliation  KM Shah Dental College and Hospital,Vadodara 
Address  Department of Pediatric and Preventive Dentistry, KM Shah Dental College and Hospital Sumandeep Vidyapeeth Deemed to be University , Vadodara , GUJARAT, INDIA
Department of Pediatric and Preventive Dentistry, KM Shah Dental College and Hospital Sumandeep Vidyapeeth Deemed to be University , Vadodara , GUJARAT, INDIA
Vadodara
GUJARAT
391760
India 
Phone  9158763357  
Fax    
Email  gattanikp@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Bhavna Dave 
Designation  Guide 
Affiliation  KM Shah Dental College and Hospital,Vadodara 
Address  Department of Pediatric and Preventive Dentistry, KM Shah Dental College and Hospital Sumandeep Vidyapeeth Deemed to be University , Vadodara , GUJARAT, INDIA
Department of Pediatric and Preventive Dentistry, KM Shah Dental College and Hospital Sumandeep Vidyapeeth Deemed to be University , Vadodara , GUJARAT, INDIA
Vadodara
GUJARAT
391760
India 
Phone  9998034036  
Fax    
Email  bhavnadave1964@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Bhavna Dave 
Designation  Guide 
Affiliation  KM Shah Dental College and Hospital,Vadodara 
Address  Department of Pediatric and Preventive Dentistry, KM Shah Dental College and Hospital Sumandeep Vidyapeeth Deemed to be University , Vadodara , GUJARAT, INDIA
Department of Pediatric and Preventive Dentistry, KM Shah Dental College and Hospital Sumandeep Vidyapeeth Deemed to be University , Vadodara , GUJARAT, INDIA
Vadodara
GUJARAT
391760
India 
Phone  9998034036  
Fax    
Email  bhavnadave1964@gmail.com  
 
Source of Monetary or Material Support  
KM Shah Dental College and Hospital , Sumandeep Vidyapeeth Deemed to be University At & Post Piparia, Taluka - Waghodia, District - Vadodara, Gujarat State (India), Pincode - 391760  
 
Primary Sponsor  
Name  Dr Krushnapriya Gattani 
Address  KM Shah dental college and hospital , sumandeep vidyapeeth deemed to be university at post piparia taluka waghodia district vadodara state gujarat pin code 391760 
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 Krushnapriya Gattani  Sumandeep vidyapeeth deemed to be university , KM Shah Dental College and Hospital , Vadodara  1st Floor , Number 3 Department of Pediatric and Preventive Dentistry, KM Shah Dental College and Hospital Sumandeep Vidyapeeth Deemed to be University , Vadodara , GUJARAT, INDIA
Vadodara
GUJARAT 		 9158763357

gattanikp@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Sumandeep Vidyapeeth Institutional ethics committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K089||Disorder of teeth and supporting structures, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  lidocaine spray  topical lidocaine spray significantly reduces gagging incidents by acting on the nerve pathways, thereby reducing the need for sedation and its side effects, such as sore throat, during paediatric procedures. 
Intervention  Musical Earplug Temporal Tap Technique  Musical Earplug Temporal Tap Technique, a distraction-based behavioral intervention, combines auditory stimulus and rhythmic tapping to distract the child and potentially modulate sensory pathways involved in gagging 
Intervention  Yintang acupressure point   It a point in between eyebrows which regulate physiological activity by afferent nerve stimulation and serotonin and endorphin release, reducing gag reflex and anxiety. 
 
Inclusion Criteria  
Age From  8.00 Year(s)
Age To  12.00 Year(s)
Gender  Both 
Details  1.Children aged 8–11 years.
2.Children with Frankel behaviour rating scale 3 and 4.
3.Children requiring intraoral radiographic film placement as part of routine dental treatment.
4.Children with a mild to moderate gag reflex Grade II to IV as per the Dickinson and Fiske Gagging Severity Index.
5.Parents or legal guardians who provide written informed consent for participation in the study.
 
 
ExclusionCriteria 
Details  1.Children with systemic or mental disorders.
2.Sensory Impairment Children with visual or auditory impairments that may impact their ability to participate in the distraction techniques.
3.Current Use of Anxiolytic Medication Children currently taking anxiolytic medication or other sedatives that may impact their anxiety levels or ability to participate in the study.
4.Children with a severe gag reflex Grade V as per the Dickinson and Fiske Gagging Severity Index.
5.Children with allergic reactions or contraindications to the study interventions example lidocaine
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Alternation 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
This study will help us to determine effectiveness of lidocaine spray , acupressure point and musical earplug temporal tal technique in reducing gag reflex and to improve patient cooperation, reduce procedural anxiety, and enhance diagnostic accuracy.  Before and after radiographic film placement. 
 
Secondary Outcome  
Outcome  TimePoints 
The clinician can use these techniques to reduce gag reflex.  Before and after radiographic film placement. 
 
Target Sample Size   Total Sample Size="48"
Sample Size from India="48" 
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)   09/03/2026 
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="6"
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 - NO
Brief Summary  

One of the challenge faced by pediatric dentist is frequent occurrence of gag reflex in pediatric patients, which can interfere with routine procedures like radiographic imaging, leading to treatment delays, increased anxiety, and avoidance behaviors Thus to overcome these different management strategies have been used in our study . These are 2% topical lidocaine spray, Yintang acupressure, and the Musical Earplug Temporal Tap Technique. The findings from this study is designed and intended to provide evidence-based guidance for pediatric dental practitioners, helping to improve patient cooperation, reduce procedural anxiety, and enhance diagnostic accuracy.

 
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