| CTRI Number |
CTRI/2020/12/029699 [Registered on: 10/12/2020] Trial Registered Prospectively |
| Last Modified On: |
08/08/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia
Dentistry
Behavioral |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of reduction in anxiety using conscious sedation and conventional behaviour management techniques |
|
Scientific Title of Study
|
Comparison of anxiety level during treatment and subsequent visit between two different protocols of nitrous oxide-oxygen sedation and conventional behavior management in 6 to 12 year old children - a randomized controlled trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Rupali Sheshrao Barate |
| Designation |
Post graduate |
| Affiliation |
Y.M.T dental college and hospital, kharghar |
| Address |
Room no 21, department of pediatric and preventive dentistry,sector 4,Kharghar
Thane
MAHARASHTRA
410210
India |
| Phone |
09702335638 |
| Fax |
|
| Email |
rupali.barate79@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Subhadra HN |
| Designation |
Associate professor |
| Affiliation |
Y.M.T dental college and hospital, kharghar |
| Address |
Room no 21, department of pediatric and preventive dentistry, sector 4, Kharghar
Thane
MAHARASHTRA
410210
India |
| Phone |
09702335638 |
| Fax |
|
| Email |
drsubhadrahn@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rupali Sheshrao Barate |
| Designation |
Post graduate |
| Affiliation |
Y.M.T dental college and hospital, kharghar |
| Address |
Room no 21, department of pediatric and preventive dentistry, sector 4, Kharghar
Thane
MAHARASHTRA
410210
India |
| Phone |
09702335638 |
| Fax |
|
| Email |
rupali.barate79@gmail.com |
|
|
Source of Monetary or Material Support
|
| Y.M.T. dental college and hospital, 18 sector 4, kharghar 410210 |
|
|
Primary Sponsor
|
| Name |
Dr Rupali Barate |
| Address |
21, department of pediatric and preventive dentistry, Y.M.T dental college and hospital, sector 4, kharghar |
| Type of Sponsor |
Other [Dr. Rupali Barate as it is a self-sponsored trial ] |
|
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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 |
| Dr Rupali Barate |
Y.M.T. dental college and hospital |
Department of pediatric and preventive dentistry institutional area, sector-4, Kharghar, 41021o
Raigarh
MAHARASHTRA |
09702335638
rupali.barate79@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K00-K14||Diseases of oral cavity and salivary glands, |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
conventional behavior management techniques. |
Treatment of patients under this group will be carried out under conventional behavior management techniques such as tell show do, modelling, distraction |
| Intervention |
Nitrous oxide-oxygen sedation vs conventional behavior management techniques |
Nitrous oxide oxygen sedation is one of the effective methods of behavior management of anxious children. Nitrous oxide causes “relative analgesia†chemically altered psychological state which eliminates the fear and pain of the dental experience. It is easy to administer, has wide analgesic and anxiolytic effects and wide margin of safety. Patients will be assessed and recruited into the study on the first visit. They will be divided randomly into three groups.
Group A: All the treatment under conventional behavior management
Group B: Nitrous oxide-oxygen sedation, only in the treatment visit requiring LA administration
Group C: Nitrous oxide-oxygen sedation from the first treatment visit
Anxiety assessment will be done for all the groups on the first, second, third and fourth visit.
The duration of therapy will be up to 1 hour. The frequency will depend on the number of seatings required for the treatment |
|
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Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
1. ASA category 1 children aged 6-12 years.
2. Children with CFSS –DS score above 32, indicative of moderate to high dental anxiety.
3. Children requiring at least one procedure which requires LA administration and one restoration. |
|
| ExclusionCriteria |
| Details |
1. Children suffering from any conditions which may hinder their participation.
2. Children with limited cognitive abilities (cognitive impairment/intellectual disability)
3. Children whose parents refuse to give consent.
4. Children unable to breathe through their nose. |
|
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Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Self-reported anxiety levels will be measured using Children’s fear survey schedule-Dental Subscale (CFSS-DS): 15 items rated on 5 point scale, ranging from 1 (not afraid) to 5 (very afraid). The total score is calculated by summing item score.
Facial image scale: A pre-validated 5 point scale.
Observer rating of behavior will be measured using
Global rating scale: A pre-validated 5 point scale.
Venham’s clinical anxiety scale: A pre-validated 6 point scale. |
Anxiety assessment will be done at the first visit that is baseline and after one week and after two weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Acceptability of nitrous oxide-oxygen sedation: will be assessed by likert scale: 3 point categorical scale |
Acceptability assessment will be done at the end of the visit that is baseline and one week after and two week after baseline |
|
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Target Sample Size
|
Total Sample Size="45"
Sample Size from India="45"
Final Enrollment numbers achieved (Total)= "45"
Final Enrollment numbers achieved (India)="45" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/01/2021 |
| Date of Study Completion (India) |
09/09/2021 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
09/09/2021 |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NIL |
|
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
|
In our study we plan to assess and compare 1) the overall average anxiety level in 6 to 12 year old children who receive dental treatment under two different protocols of nitrous oxide-oxygen sedation and conventional behavior management techniques. 2) the anxiety level in 6 to 12 year old children who receive dental treatment under two different protocols of nitrous oxide-oxygen sedation and conventional behavior management techniques on three different visits. 3) To compare anxiety level of children in the first treatment visit to anxiety level in the subsequent visit in all the groups. Our proposed primary research hypothesis is nitrous oxide-oxygen sedation can reduce anxiety levels in 6 - 12 year old children compared to the conventional behavior management techniques in treatment and subsequent visit. |