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
|
|
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
|
|
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. |