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CTRI Number  CTRI/2022/02/040548 [Registered on: 23/02/2022] Trial Registered Prospectively
Last Modified On: 22/02/2022
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry
Behavioral 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Dental anxiety assessment in children for different dental restorative procedures. 
Scientific Title of Study   COMPARISON OF DENTAL ANXIETY BETWEEN AEROSOL AND NON- AEROSOL DENTAL PROCEDURES IN CHILDREN AGED BETWEEN 5-13 YEARS 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Yuthi Milit 
Designation  Post Graduate Student 
Affiliation  M R Ambedkar Dental College and Hospital 
Address  Room no.7, Dept. of Pedodontics and Preventive Dentistry, M R Ambedkar Dental College and Hospital, Cline Road, Cooke Town, Bangalore, Karnataka-560005

Bangalore
KARNATAKA
560005
India 
Phone  8759901671  
Fax    
Email  yuthi.milit@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Jyothsna V Setty 
Designation  Professor  
Affiliation  M R Ambedkar Dental College and Hospital 
Address  Room no.7, Dept. of Pedodontics and Preventive Dentistry, M R Ambedkar Dental College and Hospital, Cline Road, Cooke Town, Bangalore, Karnataka-560005

Bangalore
KARNATAKA
560005
India 
Phone  9449819468  
Fax    
Email  jyothsnasrikanth@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Jyothsna V Setty 
Designation  Professor  
Affiliation  M R Ambedkar Dental College and Hospital 
Address  Room no.7, Dept. of Pedodontics and Preventive Dentistry, M R Ambedkar Dental College and Hospital, Cline Road, Cooke Town, Bangalore, Karnataka-560005

Bangalore
KARNATAKA
560005
India 
Phone  9449819468  
Fax    
Email  jyothsnasrikanth@gmail.com  
 
Source of Monetary or Material Support  
M R AMBEDKAR DENTAL COLLEGE AND HOSPITAL 
 
Primary Sponsor  
Name  Dr Yuthi Milit 
Address  M R Ambedkar Dental College and Hospital, Cline Road, Cooke Town, Bangalore, Karnataka-560005 
Type of Sponsor  Other [M R Ambedkar Dental College and Hospital- Private Dental College] 
 
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 Yuthi Milit  M R Ambedkar Dental College and Hospital  M R Ambedkar Dental College and Hospital, Cline Road, Cooke Town, Bangalore, Karnataka -560005
Bangalore
KARNATAKA 
8759901671

yuthi.milit@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE- M R Ambedkar Dental College and Hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Dental Caries 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  5.00 Year(s)
Age To  13.00 Year(s)
Gender  Both 
Details  1.The sample will comprise of children visiting the dental clinic for the first time and aged between 5-13 years who require dental procedures either aerosol techniques including Stainless Steel Crown placement or restorative procedures or non-aerosol techniques including hall technique and Atraumatic restorative treatment.
2.Patients who are willing to participate in the study.
 
 
ExclusionCriteria 
Details  1.Patients with a history of systemic disease, hospitalization or surgery and those with chronic illness.
2.Patients who have a history of diagnosed neuro-behavioral disorders such as autism, attention deficit hyperactivity disorder, congenital syndromes and intellectual disability.
3. Patients in need of emergency treatment such as trauma patients complaining of fracture or swelling etc.
4.Patients who are not willing to participate in the study.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Determination and comparison of anxiety level between different dental treatment procedures.  During the first dental treatment visit anxiety level assessment will be done
1. Prior to initiating the treatment
2. During the treatment procedure
3. After the treatment is complete 
 
Secondary Outcome  
Outcome  TimePoints 
To defer or adapt more appropriate dental procedures which are more child friendly so that it helps us to provide comfortable dental experience for the children and also to instill positive attitude towards dentistry.  On successive dental treatment visits 
 
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   N/A 
Date of First Enrollment (India)   01/03/2022 
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="10"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   Study not yet started and no publication done. 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

Dental treatments are well known to trigger anxiety and fear in children and this not only impacts the quality of treatment but also the attitude of a child towards the dentists and dental care. Although many studies are available on evaluation of overall anxiety levels in patients towards dentistry, not many regarding on different dental treatments and their effects. There are different approaches towards dental ailments involving various techniques for the treatment of dental problems, few of them being less invasive and intimidating than others. Aerosol techniques involving rotary instruments such as in cases of pulpectomy, conventional restorations or placement of stainless-steel crown are said to be more frightening to children than treatments involving non aerosol techniques such as Atraumatic restorative treatments or HALL technique for stainless steel crown. Thus, other than injections or syringes, dental drill are said to make children more uncomfortable.

So, the overall effect of dental fear and anxiety is multifaceted, such that the children want to avoid their dental appointments ultimately leading to worse oral health which is non restorable sometimes.

It is a scientifically proven fact that anxiety brings about many physiological changes in body such as increased respiratory rate, increased perspiration, blood pressure, heart rate and pulse rate. All these signs are due to the release of stress hormones in the blood such as cortisol, adrenaline, and nor-epinephrine.

Thus, in our study we will be assessing anxiety by measuring blood pressure & pulse rate, self-reported state of anxiety by child friendly animated emoji scale and also physical and behavioral assessment by the operator using FLACC scale which will help us to use more child friendly techniques for restoring oral health in children.

 
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