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CTRI Number  CTRI/2025/08/092482 [Registered on: 06/08/2025] Trial Registered Prospectively
Last Modified On: 05/08/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Efficacy of cotton-candy flavored edible oil and audio-visual therapy on pain perception and anxiety among children aged 6-9 years on administration of inferior alveolar nerve block 
Scientific Title of Study   Efficacy of cotton-candy flavored edible oil and audio-visual therapy on pain perception and anxiety among children aged 6-9 years on administration of inferior alveolar nerve block: A Randomized Clinical trial. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Simran Deorukhkar 
Designation  Post Graduate Student 
Affiliation  Dr. D.Y. Patil Dental College and Hospital, Pimpri, Pune 
Address  Department of Pediatric and Preventive Dentistry, Dr. D.Y. Patil Dental College and Hospital, Sant Tukaram Nagar, Pimpri, Pune

Pune
MAHARASHTRA
411018
India 
Phone  9757362682  
Fax    
Email  srd.vlp56@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Lalit Patil 
Designation  Associate Professor  
Affiliation  Dr. D.Y. Patil Dental College and Hospital, Pimpri, Pune 
Address  Department of Pediatric and Preventive Dentistry, Dr. D.Y. Patil Dental College and Hospital, Sant Tukaram Nagar, Pimpri, Pune

Pune
MAHARASHTRA
411018
India 
Phone  9765370827  
Fax    
Email  drlalitpatil47@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Lalit Patil 
Designation  Associate Professor  
Affiliation  Dr. D.Y. Patil Dental College and Hospital, Pimpri, Pune 
Address  Department of Pediatric and Preventive Dentistry, Dr. D.Y. Patil Dental College and Hospital, Sant Tukaram Nagar, Pimpri, Pune

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  Simran Deorukhkar 
Address  Department of Pediatric and Preventive Dentistry, Dr. D.Y. Patil Dental College and Hospital, Sant Tukaram Nagar, Pimpri, Pune - 411018 
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 
Lalit Patil  Dr. D. Y Patil Dental College and Hospital, Pimpri, Pune  Department number 8, Second floor, Department of Pediatric and Preventive Dentistry, Pune, Maharashtra
Pune
MAHARASHTRA 
9765370827

drlalitpatil47@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Dr.D.Y.Patil Vidyapeeth,Pune  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Children aged 6-9 years 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Audio-visual distraction  Audio-visual distraction is the most common distraction technique which is preferred by many dentists. Audio-visual distraction calms the child by camouflaging the sounds during dental procedure 
Intervention  Sucrose Analgesia  LorAnn flavours have been used since a long time. As these products are Kosher certified, it can used in children as well. Cotton candy flavour is most preferred by the children. It gives a sweet taste in cooking. Claiming the product to be sugarfree, it can also be used in children with high caries risk. Here sucrose is replaced by malt sugar which makes it sugarfree 
 
Inclusion Criteria  
Age From  6.00 Year(s)
Age To  9.00 Year(s)
Gender  Both 
Details  1.Healthy children of age 6 to 9 years.
2.Frankl’s behavior rating score 2 and 3.
3.Mandibular carious molar undergoing procedures requiring inferior alveolar nerve block. 
 
ExclusionCriteria 
Details  1.Frankl’s behavior rating score 1 and 4.


2.Children with special health care needs.


3.Children with hearing problems.


4.Children with systemic diseases.
 
 
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 efficacy of sugar free cotton candy flavored edible oil and audio-visual therapy on pain perception and dental anxiety in children on administration of local anesthesia.
 
Post application 
 
Secondary Outcome  
Outcome  TimePoints 
To evaluate efficacy of sugar free cotton candy flavored edible oil on pain perception & dental anxiety in children on administration of local anesthesia.


2.To evaluate efficacy of audio-visual therapy on pain perception & dental anxiety in children on administration of local anesthesia. 
Post application 
 
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)   20/08/2025 
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="3"
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  

Brief Resume of the intended work

7.1 Need for the study :

The success rate of any dental treatment in pediatric patients depends upon certain factors which include, the successful Behaviour management of the child, relieving the fear and anxiety associated with the treatment and the quality of the treatment provided.  The main aim of behavior management is to alleviate child’s fear and anxiety during dental treatment.

 

 

The main fear of children while visiting the dentist is trypanophobia. Inferior alveolar nerve block is most commonly used during dental visit. Children become uncooperative while administration of local anesthesia1 and hence various techniques have been used to make them more comfortable during the procedure.

 

 

Audiotherapy has proved to be useful distraction technique in children . Children prefer listening to rhymes while undergoing dental treatment.  Music sends enough concurrent sensory  inputs through descending pathways of the brain to cause the brain stem to signal some of the closed gates, thereby reducing the amount of pain the patient hearing the music

perceive2

 

 

Sucrose Analgesia is one of the recent advances. Sweet taste solution play an important role in distracting children during dental treatment. They act on first and second order neuron, thereby reducing the pain threshold.3

 

Hence a present study is undertaken to compare both the techniques in terms of pain perception and dental anxiety in children.


.2 Review of Literature :

 

1.     Ola B. Al-Batayneh (2024) et al conducted a study on efficacy of sugar free flavor on pain perception before local anesthesia in children. This was a split mouth randomized crossover clinical trial. Pain perception was checked by application of sugarfree flavor before administration of local anesthesia. This study concluded that using a sugarfree flavor helps in reducing pain before local anesthesia.4

 

2.     Ishani Ratnaparkhi (20224) et al conducted a study on efficacy of sucrose application in minimizing pain perception in dental injections in children. This was a randomized clinical trial. Sucrose solution was applied on lateral surface of the tongue and pain perception was checked before administering local anesthesia. This study concluded that application of sucrose before local anesthesia minimizes the pain in children.5

 

 

 

3.     Devendra Nagpal (2023) et al conducted a study on effect of audio distraction and thermomechanical stimulation on pain perception in children. This was a randomized clinical trial. Thermomechanical stimulation along with audio therapy was used to assess the pain perception in children. This study concluded that less pain on injection was observed when audio distraction along with thermomechanical stimulation was used.6

 

4.     Supriya Thambireddy (2023) et al conducted a study on alleviating needle pain using sucrose solution before administering inferior alveolar nerve block in children. This was a randomized clinical trial. 30% sucrose solution was given before administering local anesthesia and pain perception was assessed. This study concluded that oral administration of sucrose reduces pain of local anesthesia in children.7

 

 

 

5.     Gonzalo A. Rojas-Alcayaga (2018) et al conducted a study on effect of music therapy on dental anxiety in children. This was a randomized clinical trial. Children were exposed to musical distraction and anxiety of child during dental treatment was assessed. This study concluded that music distraction had no significant effect on dental anxiety. 8

7.3 Aim of Study : 

To compare efficacy of audiotherapy and sugarfree oil-flavor on pain perception and dental anxiety in children on administration of local anesthesia.

1.To evaluate efficacy of sugar free cotton candy flavored edible oil on pain perception and dental anxiety in children on administration of local anesthesia.

 

 

2.To evaluate efficacy of audio-visual therapy on pain perception and dental anxiety in children on administration of local anesthesia.

 

 

3.To evaluate and compare efficacy of sugar free cotton candy flavored edible oil and audio-visual therapy on pain perception and dental anxiety in children on administration of local anesthesia.

 
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