| 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 |
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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 |
|
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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] |
|
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Details of Secondary Sponsor
|
|
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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 |
|
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Regulatory Clearance Status from DCGI
|
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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 |
|
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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.
|
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Method of Generating Random Sequence
|
Computer generated randomization |
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Method of Concealment
|
An Open list of random numbers |
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Blinding/Masking
|
Participant and Outcome Assessor Blinded |
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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 |
|
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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 |
|
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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
|
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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. | | | |