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CTRI Number  CTRI/2024/07/071265 [Registered on: 25/07/2024] Trial Registered Prospectively
Last Modified On: 27/02/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Behavioral 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Artificial Intelligence Application to reduce dental fear and anxiety in children undergoing dental treatment. 
Scientific Title of Study   Comparative Evaluation of the Effectiveness of an Audiovisual Distraction Aid with an Augmented Reality based App in Pediatric Patients with Dental Fear and Anxiety 
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 Aditi Tasgaonkar 
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,Pimpri,Pune

Pune
MAHARASHTRA
411018
India 
Phone  919921363344  
Fax    
Email  adititasgaonkar98@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Nilesh Rathi  
Designation  Head of the Department  
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,Pimpri,Pune

Pune
MAHARASHTRA
411018
India 
Phone  9960100010  
Fax    
Email  nilesh.rathi@dpu.edu.in  
 
Details of Contact Person
Public Query
 
Name  Dr Nilesh Rathi  
Designation  Head of the Department  
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,Pimpri,Pune

Pune
MAHARASHTRA
411018
India 
Phone  9960100010  
Fax    
Email  nilesh.rathi@dpu.edu.in  
 
Source of Monetary or Material Support  
Dr. D.Y.Patil Dental College and Hospital,Pimpri,Pune 
 
Primary Sponsor  
Name  DrAditi Prasad Tasgaonkar 
Address  Radhai, Shahu colony, Lane 2, near Cummins College of engineering, Karvenagar, Pune  
Type of Sponsor  Other [Personal funds] 
 
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 Aditi Tasgaonkar   Dr. D.Y. Patil Dental College and Hospital  Department of Pediatric and Preventive Dentistry, Department No. 8, Second floor
Pune
MAHARASHTRA 
99213633344

adititasgaonkar98@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Dr. D.Y. Patil Dental College and Hospital Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Dental caries with reversible/irreversible pulpitis 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Effectiveness of an audiovisual distraction aid in pediatric patients with dental fear and anxiety.   Duration of intervention is 30 minutes  
Intervention  Effectiveness of an Augmented Reality(AR) based app in pediatric patients with dental fear and anxiety.   Duration of intervention is 30 minutes  
 
Inclusion Criteria  
Age From  6.00 Year(s)
Age To  12.00 Year(s)
Gender  Both 
Details  Patients aged from 6-12 years.
Patients showcasing behaviour according to the Frankl behaviour rating scale 2,3 and 4.
Patients requiring restorative treatment.
 
 
ExclusionCriteria 
Details  Specially abled patients.
Patients with any systemic disorders or psychological conditions.
Patients reporting with trauma, swelling or other emergencies.
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
To evaluate augmented reality based app in pediatric patients to reduce dental fear and anxiety   To evaluate augmented reality based app in pediatric patients to reduce dental fear and anxiety at baseline prior to intervention, during intervention and immediately after intervention. 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="80"
Sample Size from India="80" 
Final Enrollment numbers achieved (Total)= "40"
Final Enrollment numbers achieved (India)="40" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   01/09/2024 
Date of Study Completion (India) 04/02/2025 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) 04/02/2025 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Completed 
Recruitment Status of Trial (India)  Completed 
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 - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response (Others) -  None
  3. Who will be able to view these files?
    Response (Others) -  none

  4. For what types of analyses will this data be available?
    Response (Others) -  none

  5. By what mechanism will data be made available?
    Response - Data are available indefinitely at (Link to be included adititasgaonkar98@gmail.com).

  6. For how long will this data be available start date provided 01-01-2026 and end date provided 02-01-2027?
    Response (Others) -  none

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - None
Brief Summary
Modification(s)  
Need for the study
1. Most Children who visit the dental clinic experience pre-operative anxiety related to the dental treatment and a fear when they experience the clinical setting for the first time which mainly includes the dental chair and instruments.
2. This Fear and Anxiety related to dental procedures if not resolved properly can have a significant impact on the child’s life which includes a lifetime barrier to seek proper oral health care.1
3. Dental Fear and Anxiety is a very common problem in children and adolescents with a prevalence rate of around 12-20 % and thus new strategies to overcome this should be encouraged.
4. According to the recent guidelines given by the American Association of Pediatric Dentistry (AAPD) in 2020, the best way to practice is by reinforcing a positive attitude, to reduce the dental fear and anxiety by various behaviour guidance methods.2
5. Basic behaviour guidance includes communication guidance, positive pre-visit imagery, direct observation, tell-show-do, voice control, non-verbal communication, positive reinforcement and descriptive praise, distraction, and desensitization. For anxious patients, additional behavior guidance options include sensory adapted dental environments, animal assisted therapy, picture exchange communication systems, and nitrous oxide-oxygen inhalation can be used. 2
6. Recent advances in relation to Audio-visual distractions, Virtual Reality eye pieces, Virtual Reality head gears, games and Augmented reality applications for dental education and desensitization are being used by Paediatricians in day-to-day clinical practice.
7. With the increase in use of technology by children and adolescents it has become one of the most popular aids for reducing dental anxiety and fear.

7.2 Review of Literature
1. Rajeshwari et al (2019) – The aim of this study was to utilize Cognitive behavioural play therapy and audiovisual distraction aids in evaluation of management of preoperative anxiety in children aged 6-10 years. Total 45 children with preoperative anxiety were divided into 3 groups where they were subjected to cognitive behaviour play therapy (CBT), audiovisual(AV) distraction aids and tell show do technique respectively. Pre intervention and post intervention anxiety scores were measured using Facial Image scale (FIS) and pulse oximeter. The results suggested that there was a reduction in anxiety in the children in both intragroup and intergroup comparison. The reduction in the anxiety scores was seen majorly in CBT when compared the AV distraction aid and tell show do technique. Thus, they have concluded that, distraction for children with preoperative dental anxiety was best achieved with cognitive behaviour therapy play. This research article forms an important niche for our study as it provides the analytical comparison in the preoperative anxiety management techniques
2. Qin Du et al (2022) – The aim of this study was to check the effectiveness of a unique Virtual Reality(VR) based helmets to reduce dental anxiety in children undergoing extraction of primary teeth under the effect of local anaesthesia. In this randomized control trial, 128 children were allocated into two groups. Group 1 was where they used the VR helmets and Group 2 was where conventional behaviour guidance procedures were applied. Modified Child Fear Survey Schedule Dental Subscale (CFSS-DS), Wong Bakers FACES Pain Scale, Houpt Scale and Simulator Sickness Questionaire (SSQ) were the different scales taken into consideration. Dental anxiety, pain perception with occurrence of simulator sickness was assessed. There was a significant decrease in the readings of the CFSS-DS scores and Wong Baker scale scores when the VR helmet was utilized. While, no significant difference was seen in the readings of the Houpt behaviour scale scores. Thus, it was concluded that, VR helmets reduce dental anxiety and pain perception in pediatric patients while undergoing dental procedures without simulator sickness.
3. American Acedemy of Pediatric Dentistry (2022) – The article aims in providing the recent (2020) guidelines for Behaviour Guidance for Pediatric dental patients. The predicators of child behavior, patient assessment along with parental influences were discussed. Recommendation of various behaviour guidance techniques are also discussed. The include, conventional techniques also the advance behavior guidance model. The inference of the guidelines is that best clinical practice for children undergoing dental treatment could be done by applying customized behaviour guidance plans.
4. Fakhruddin et al (2015) – The article aimed to evaluate the effectiveness of audiovisual distraction eyewear and computerized delivery of anesthesia during invasive dental treatment in children aged between 4 and 7 years of age. It was a randomized crossover clinical trial. Total of 60 children were distributed equally in two groups and two sessions of pulp therapy was performed one week apart. Group 1 had audiovisual distraction eyewear and group 2 consisted of audiovisual distraction aid projected on a screen. Pre-treatment Modified child dental Anxiety scores were checked by the operator. Post treatment the children were asked to rate their pain using the Wong Bakers Facial pain scale. Changes in pulse oximeter and and heart rate were also recorded at certain time intervals. The conclusions drawn were, the audiovisual aids using eyewear were more effective to reduce preoperative anxiety thus improving the child’s cooperation during the dental procedure. Thus, they suggest the use of a more personalized distraction aid for better effect in managemt of preoperative anxiety and fear in pediatric patients undergoing invasive dental procedures.

Aim of the study- To evaluate the effectiveness of an Augmented Reality (AR) based app in Pediatric Dentistry

Objectives of the study
pediatric patients with dental fear and anxiety.
1. To prepare an AI based behaviour modelling app in Pediatric dentistry
2.To evaluate dental fear, dental anxiety and vitals with an Augmented Reality based app for behavior guidance in pediatric patients.

Materials and Methods
1 Source of data.
● Type of study -in-vivo
● Source from where the cases, patients, subjects or study material will be selected - Patients reporting to Department of Pediatric and preventive dentistry at Dr.D.Y. Patil dental college and hospital, Pune
● Name and place where the study will be conducted- Department of Pediatric and preventive dentistry at Dr.D.Y. Patil dental college and hospital, Pune
2 Method of data collection
● Sampling technique used – random
● Sample size – number of cases/samples/specimen/patients/groups- 40


Procedure of the study- 
Prior to starting the research work, permission to conduct the study will be obtained from the Scientific and Ethical committee of the Dr. D.Y. Patil Dental College and Hospital.
A written informed consent will be duly obtained from the parents prior to the conduction of the study
1. After obtaining clearance from the institutional ethical review committee and scientific committee, the process of developing an application will be done.
2. For the development of the app, a video will be shot as a template showing a conventional tell show do technique, followed by a patient undergoing a restorative treatment and later receiving a sticker as a positive reinforcement method of behaviour guidance.
3. The patients who have reported to the Department of Pediatric and Preventive Dentistry at Dr. D. Y. Patil Dental College and Hospital, Pimpri will be considered for the study.
4. The patients will be selected according to the inclusion criteria by an observer with a minimum experience of 5 years as a Pediatric dentist.

6.The statistical test/s used to analyze the data. distraction of behaviour guidance, where the augmented reality app will be used as an aid for behaviour guidance.
7.Before the trial in the clinics, the purpose of the study will be explained and the informed consent will be obtained from parents or guardians from both the groups.
8.Anxiety and fear of the patient will be assessed using the respective scales for the groups before intervention.
9. Pre intervention vitals for the patient will be assessed.
10. AR based app will be used. Photos of the patient will be clicked according to the specifications.
11. The app will transform the photos of the anxious patient into AR video. The video will be shown to the patient on a screen/tab
12. The fear and anxiety scores will be assessed using the respective scales post intervention Modified child dental anxiety scales(MCDASf), Child’s fear Survey Schedule- Dental Subscal
13.Post intervention vitals will be assessed for the patient
14.Comparison of the scales and vital parameters will be done and the generated results will be analysed statistically.

Does the study require any investigation or intervention to be made on patients, any human or animals?
NONE


List of References
1. Al-Namankany A, de Souza M, Ashley P. Evidence-based dentistry: analysis of dental anxiety scales for children. Br Dent J. 2012 Mar 9;212(5):219-22. doi: 10.1038/sj.bdj.2012.174. PMID: 22402535
2. American Academy of Pediatric Dentistry. Behavior guidance for the pediatric dental patient. The Reference Manual of Pediatric Dentistry. Chicago, Ill.: American Academy of Pediatric Dentistry; 2022:321-39.
3. Cianetti S, Lombardo G, Lupatelli E, Pagano S, Abraha I, Montedori A, Caruso S, Gatto R, De Giorgio S, Salvato R. Dental fear/anxiety among children and adolescents. A systematic review. Eur J Paediatr Dent. 2017 Jun;18(2):121-130. doi: 10.23804/ejpd.2017.18.02.07. PMID: 28598183.
4. Rajeswari SR, Chandrasekhar R, Vinay C, et al. Effectiveness of Cognitive Behavioral Play Therapy and Audiovisual Distraction for Management of Preoperative Anxiety in Children. Int J Clin Pediatr Dent 2019;12(5):419–422
5. Du,Q., Ma, X.,Wang, S., Zhou, S., Luo, C., Tian, K., Fei,W., & Liu, X. (2022). A digital intervention using virtual reality helmets to reduce dental anxiety of children under local anesthesia and primary teeth extraction: A randomized clinical trial. Brain and Behavior, 12, e2600.
6. Andy Wai Kan Yeung, Anela Tosevska, Elisabeth Klager, Fabian Eibensteiner, Daniel Laxar, Jivko Stoyanov, Marija Glisic, Sebastian Zeiner, Stefan Tino
10
Kulnik, Rik Crutzen, Oliver Kimberger, Maria Kletecka-Pulker, Atanas G Atanasov, Harald Willschke. Originally published in the Journal of Medical Internet Research (http://www.jmir.org), 10.02.2021.
7. Tiwari S, Kulkarni P, Agrawal N, et al. Dental Anxiety Scales used in Pediatric Dentistry: A Systematic Review and Meta-analysis. J Contemp Dent Pract 2021;22(11):1338–1345.
8. Delgado A, Ok SM, Ho D, Lynd T, Cheon K. Evaluation of children’s pain expression and behavior using audio visual distraction. Clin Exp Dent Res. 2021 Oct;7(5):795-802. doi: 10.1002/cre2.407. Epub 2021 Feb 23. PMID: 33622030; PMCID: PMC8543459.
9. Fakhruddin KS, El Batawi H, Gorduysus MO.Effectiveness of audiovisual distraction eyewear and computerized delivery of anesthesia during pulp therapy of primary molars in phobic child patients. Eur J Dent 2015;9:470-5.
10. Deogade SC, Suresan V. Psychometric assessment of anxiety with the Modified Dental Anxiety scale among central Indian adults seeking oral health care to a dental school. Ind Psychiatry J 2016;25:202-9.
11. Cunningham A, McPolin O, Fallis R, Coyle C, Best P, McKenna G. A systematic review of the use of virtual reality or dental smartphone applications as interventions for management of paediatric dental anxiety. BMC Oral Health. 2021 May 7;21(1):244. doi: 10.1186/s12903-021-01602-3. PMID: 33962624; PMCID: PMC8103574.
12. Klingberg G. Dental fear and behavior management problems in children. A study of measurement, prevalence, concomitant factors, and clinical effects. Swed Dent J Suppl. 1995;103:1-78. PMID: 7740439.
13. Felemban OM, Alshamrani RM, Aljeddawi DH, Bagher SM. Effect of virtual reality distraction on pain and anxiety during infiltration anesthesia in pediatric patients: a randomized clinical trial. BMC Oral Health. 2021 Jun 25;21(1):321. doi: 10.1186/s12903-021-01678-x. PMID: 34172032; PMCID: PMC8234622.
14. HOWARD, K.E. and FREEMAN, R. (2007), Reliability and validity of a faces version of the Modified Child Dental Anxiety Scale. International Journal of Paediatric Dentistry, 17: 281-288. https://doi.org/10.1111/j.1365-263X.2007.00830.x
15. Malhotra R, Gandhi K, Kumar D, Ahuja S, Kapoor R, Sahni A. A Comparative Study to evaluate Parent’s Ability to assess Dental Fear in their 6- to 10-year-old Children using Children’s Fear Survey Schedule—Dental Subscale. Int J Clin Pediatr Dent 2018;11(3):205-209
 
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