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CTRI Number  CTRI/2024/04/065042 [Registered on: 01/04/2024] Trial Registered Prospectively
Last Modified On: 29/03/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Diagnostic
Preventive
Screening
Dentistry
Behavioral 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   management of dental anxiety in children by exposing them to sensory adapted dental environment 
Scientific Title of Study   Impact of Sensory Adapted Dental Environment in the management Of Dental Anxiety In Children-A Randomized Controlled 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  Lakshmi Thribhuvanan 
Designation  Assistant Professor 
Affiliation  DR DY PATIL VIDYAPEETH, DR DY PATIL DENTAL COLLEGE AND HOSPITAL 
Address  DEPARTMENT OF PEDIATRIC AND PREVENTIVE DENTISTRY DR DY PATIL DENTAL COLLEGE AND HOSPITAL, DR DY PATIL VIDYAPEETH PIMPRI PUNE

Pune
MAHARASHTRA
411018
India 
Phone  8055018941  
Fax    
Email  lakshmi.thribhuvanan@dpu.edu.in  
 
Details of Contact Person
Scientific Query  
Name  Nilesh Rathi  
Designation  Professor and HOD 
Affiliation  DR DY PATIL VIDYAPEETH, DR DY PATIL DENTAL COLLEGE AND HOSPITAL 
Address  DEPARTMENT OF PEDIATRIC AND PREVENTIVE DENTISTRY DR DY PATIL DENTAL COLLEGE AND HOSPITAL, DR DY PATIL VIDYAPEETH PIMPRI PUNE

Pune
MAHARASHTRA
411018
India 
Phone  9960100010  
Fax    
Email  nilesh.rathi@dpu.edu.in  
 
Details of Contact Person
Public Query  
Name  Nilesh Rathi  
Designation  Professor and HOD 
Affiliation  DR DY PATIL VIDYAPEETH, DR DY PATIL DENTAL COLLEGE AND HOSPITAL 
Address  DEPARTMENT OF PEDIATRIC AND PREVENTIVE DENTISTRY DR DY PATIL DENTAL COLLEGE AND HOSPITAL, DR DY PATIL VIDYAPEETH PIMPRI PUNE

Pune
MAHARASHTRA
411018
India 
Phone  9960100010  
Fax    
Email  nilesh.rathi@dpu.edu.in  
 
Source of Monetary or Material Support  
Department of Pediatric and preventive dentistry, Dr. D. Y. Patil Dental College & Hospital Sant Tukaram Nagar, Pimpri, Pune – 411018 
 
Primary Sponsor  
Name  LAKSHMI THRIBHUVANAN 
Address  SHANKESHWAR DARSHAN NEAR SHANTOSHI MATA CHOWK MUKESH NAGAR,PIMPRI,CHINCHWAD,PUNE-411018 
Type of Sponsor  Other [] 
 
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 NILESH RATHI  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 		 9960100010

nilesh.rathi@dpu.edu.in 
 
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  Deposits on teeth surface Dental caries on pit and fissures 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Regular Dental Environment  To evaluate physiological distress, pain and sensory discomfort of anxious children receiving oral health care in RDE(Regular Dental Environment) ï‚· To assess the effectiveness of regular dental environment (RDE) in reducing physiological distress, pain and sensory discomfort of anxious children receiving oral health care. ï‚· To compare the effectiveness of SADE and RDE(Regular Dental Environment) on anxious children receiving oral health care Duration of study :2 years 
Intervention  Sensory Adapted Dental Environment  To evaluate physiological distress, pain and sensory discomfort of anxious children receiving oral health care in SADE(Regular Dental Environment) ï‚· To assess the effectiveness of sensory adapted dental environment (SADE) in reducing physiological distress, pain and sensory discomfort of anxious children receiving oral health care. ï‚· To compare the effectiveness of SADE and RDE(Regular Dental Environment) on anxious children receiving oral health care Duration of study:2years 
 
Inclusion Criteria  
Age From  6.00 Year(s)
Age To  12.00 Year(s)
Gender  Both 
Details  Children of age 6-12years with dental
anxiety.
Children requiring minimum two dental
visits.
Children with no history of dental treatment. 
 
ExclusionCriteria 
Details  Children with history of significant motor
impairments or genetic or metabolic dysfunction. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
To assess the impact of a sensory adapted
dental environment in management of dental
anxiety in children 		 2 years 
 
Secondary Outcome  
Outcome  TimePoints 
nil  nil 
 
Target Sample Size   Total Sample Size="400"
Sample Size from India="400" 
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 2/ Phase 3 
Date of First Enrollment (India)   10/04/2024 
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="2"
Months="0"
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  

Need for the study

• In today’s clinical scenario managing children in dental setup still possess to be one of the greatest challenges faced by Pediatric dentists.

• The barriers in communication, an adaptive environment creates unresistable physiological distress, pain and sensory discomfort in  children.

• All previous studies have been conducted on various dental anxiety scales, this would be first clinical trial in India with Sensory Adapted Dental Environment setting.

• However adapting a  Multisensory Dental Environment (MSE)/Snoezelen will promote motivation, interests, leisure, and relaxation in managing highly anxious and uncooperative children thereby creating an acceptable environment for carrying out treatment

 Review of Literature

1. Sharon A. Cermak et.al (2015)

 

This aim of this study was to examine the impact of a sensory adapted dental environment (SADE) to reduce distress, sensory discomfort, and perception of pain during oral prophylaxis for children with autism spectrum disorder (ASD). Participants were 44 children ages 6-12 (n=22 typical, n=22 ASD). In an experimental crossover design, each participant underwent two professional dental cleanings, one in a regular dental environment (RDE) and one in a SADE, administered in a randomized and counterbalanced order three to four months apart. Outcomes included measures of physiological anxiety, behavioural distress, pain intensity, and sensory discomfort. Both groups exhibited decreased physiological anxiety and reported lower pain and sensory discomfort in the SADE condition compared to RDE, indicating a beneficial effect of the SADE.

 

2. Michele Shapiro et.al (2008)

 

The aim of this study was to evaluate the effect of a sensory-adapted dental environment (SADE) on anxiety, relaxation, and cooperation of children with developmental disabilities (CDDs). Pharmacological treatment has been widely used to reduce anxiety, but nonpharmacological methods may be similarly effective. The standardized clinical situation chosen was a dental hygiene cleaning.  A SADE was structured. Sixteen CDDs participated in an open cross-over intervention trial measuring behavioral and psychophysiological variables. There was a substantial increase in relaxation and cooperation in the SADE as opposed to the regular dental environment (RDE). This was reflected by:mean duration of anxious behaviors (SADE=9.04 minutes vs RDE=23.44 minutes; P<.01); mean magnitude of anxious behaviors (SADE=8.49 vs RDE=15.50; P<.01); cooperation levels (SADE=3.31 vs RDE=1.94; P<.01); mean electrodermal activity (EDA; SADE=1,230 vs RDE=446; P<.001); and difference in degree of relaxation by EDA (SADE=2,014 vs RDE=763; P<.004). The findings indicate the potential importance of considering the sensory-adapted environment as a preferable dental environment for this population.

 

3. Ahmad Faisal Ismail et. al (2021)

 

The objective of this study was to assess the effectiveness of multisensory�’adapted environment on children’s behaviour toward dental treatment, specifically in special need children. The main health databases were selected such as SCOPUS, Medline, CINAHL, and Dentistry and Oral Sciences. The articles were selected and extracted by two reviewers based on the Preferred Reporting Items for Systematic Review and Meta�’analysis guidelines and some predetermined exclusion criteria. Furthermore, the risk of bias assessment was done. Results: A total of 317 papers were selected at the first phase from SCOPUS (97 papers), Medline (108 papers), CINAHL (110 papers), and Dentistry and Oral Sciences (2 papers). After applying the inclusion and exclusion criteria and duplicated papers were removed, only four eligible papers were selected for final synthesis. Conclusions: Multisensory�’adapted dental environment effectively improves oral health behaviour among special needs children in terms of physiological changes, behaviours, pain, and sensory discomfort. Thus, the clinician may introduce this approach in their clinical settings.

 

 

4. Fahad Alqabba et. al(2019)

 

To provide satisfactory dental treatment in almost any child is not less than a challenge. Children with disabilities require more attention and care to achieve the desired outcome. To enhance the efficiency of dental treatment, measures are needed to be taken to minimize and ideally eliminate dental anxiety and/or fear among children. To the best of our knowledge, it is very evident in the available literature that sensory adaptive environment facilitates a great deal in decreasing dental anxiety, and enhances child cooperation towards treatment. Conversely, in context of Saudi Arabia, we noticed that in general population almost no one knows about it, as per our experience even majority of dentists were unfamiliar about sensory adaptation environment in the dental setting. Keeping an eye on severe difficulties in managing a child with disability, and evident efficiency of sensory adaption environment in reducing anxiety we recommend its use in government dental hospitals and clinics.

 

5. Antonio Fallea et.al (2022)

 

The aim of the study was to assess the efficacy for a sensory-adapted environment and targeted methods in reducing anxiety and positively influencing cooperation in children with ASD during a dental examination or specific treatments. The sample consisted of 50 Italian children with a diagnosis of ASD (36 males and 14 females; aged 9–10 years) presenting with mild intellectual disability (ID) and verbal language skills. The subjects enrolled in the study had at least two decayed teeth and all were treated in two different dental environments: regular dental environment (RDE) and sensory-adapted dental environment (SADE). 20% of the sample was successfully treated in RDE, while 68% of subjects were successfully treated in SADE. The results suggest that a sensory-adapted environment positively affects the therapeutic dental treatment in patients with ASD and reaffirm that sensory dysregulation in children with ASD is a crucial factor influencing the successful outcome of oral care.

im and Objectives of the study

Aim: To assess the  impact of a sensory adapted dental environment  in management of dental anxiety in children

  

Objectives:

· To evaluate physiological distress, pain and sensory discomfort of anxious children receiving oral health care in RDE(Regular Dental Environment)

· To assess the effectiveness of sensory adapted dental environment (SADE) in reducing physiological distress, pain and sensory discomfort of anxious children receiving oral health care.

· To compare the effectiveness of SADE and RDE(Regular Dental Environment) on anxious children receiving oral health care

 Source of data.

• Clinical Study

• Patients will be selected according to inclusion criteria from OPD of Department of Pediatric and Preventive Dentistry, Dr DY PATIL DENTAL COLLEGE AND HOSPITAL, Pimpri

• Study will be conducted in Department of Pediatric and Preventive Dentistry, Dr DY PATIL DENTAL COLLEGE AND HOSPITAL, Pimpri

8.2 Method of data collection

• Randomized controlled trial

• Sample Size: 400

INCLUSION CRITERIA

• Children of age 6-12years with dental anxiety.

• Children requiring minimum two dental visits.

• Children with no history of dental treatment.

 

EXCLUSION CRITERIA

   Children with history of significant motor impairments or genetic or metabolic dysfunction.

• Informed consent will be obtained from parents of children participating in the study  

LIST OF REFERENCES

1. Cermak SA, Stein Duker LI, Williams ME, Dawson ME, Lane CJ, Polido JC. Sensory adapted dental environments to enhance oral care for children with autism spectrum disorders: A randomized controlled pilot study. Journal of Autism and Developmental Disorders. 2015 Sep;45:2876-88.

2. Shapiro M. Sensory Modification of the Dental Clinic to Reduce Anxiety of Children with Develpmental Disability. Hebrew University of Jerusalem; 2008.

3. Fallea A, Zuccarello R, Roccella M, Quatrosi G, Donadio S, Vetri L, Calì F. Sensory-adapted dental environment for the treatment of patients with autism spectrum disorder. Children. 2022 Mar 10;9(3):393.

4. Shapiro  M, Melmed  RN, Harold  DS, Parush  S. Influence of adapted environment on the anxiety of medically treated children with developmental disabilities. J Pediatr 2009;154:546�’50.

5. Ismail AF, Azmi TM, Malek WM, Mallineni SK. The effect of multisensory-adapted dental environment on children’s behavior toward dental treatment: A systematic review. Journal of Indian Society of Pedodontics and Preventive Dentistry. 2021 Jan 1;39(1):2.

6. Alqabba F, Siddiqui AA, Freah Alshammary JA, Alateeq N, Rathore HA. Evidence-based approach to cope with dental anxiety and fear amongst children, especially those with disabilities through sensory adaptive dental environment. Saudi J Oral Dent Res. 2019;4(1):5-7.

7. Koller D, McPhersonb AC, Lockwooda I, Blain�’Moraesc S, Nolana J. The impact of Snoezelen in pediatric complex continuing care: A pilot study. J Pediatr Rehabil Med 2018;11:31�’41.

8. Baranek GT, David FJ, Poe MD, Stone WL, Watson LR. Sensory experiences questionnaire: Discriminating sensory features in young children with autism, developmental delays, and typical development. Journal of Child Psychology and Psychiatry. 2006; 47:591–601. 


 
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