| CTRI Number |
CTRI/2022/02/040572 [Registered on: 23/02/2022] Trial Registered Prospectively |
| Last Modified On: |
09/01/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Dentistry |
| Study Design |
Randomized, Crossover Trial |
|
Public Title of Study
|
Comparative Evaluation of Two Sedatives in Pediatric Dental Procedure - A Randomized Clinical Trial |
|
Scientific Title of Study
|
Comparative Evaluation of Intranasal Midazolam and Dexmedetomidine in Pediatric Dental Procedure - A Randomized Clinical Trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Kavya R Shah |
| Designation |
Post Graduate Student |
| Affiliation |
Narsinhbhai Patel Dental College and Hospital |
| Address |
Narsinhbhai Patel Dental College and Hospital
Sankalchand Patel Vidyadham
Ambaji Gandhinagar Link Road
Near Kamana Char Rasta
Visnagar 384315
Narsinhbhai Patel Dental College and Hospital
Sankalchand Patel Vidyadham
Ambaji Gandhinagar Link Road
Near Kamana Char Rasta
Visnagar 384315
Mahesana
GUJARAT
384315
India |
| Phone |
7708535361 |
| Fax |
|
| Email |
kavshah04@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shoba Fernandes |
| Designation |
Head of the Department |
| Affiliation |
Narsinhbhai Patel Dental College and Hospital |
| Address |
Narsinhbhai Patel Dental College and Hospital, S. P. Sahakar
Vidyadham, Ambaji Gandhinagar Link Road, Near Kamana Char
Rasta, Visnagar - 384315
Narsinhbhai Patel Dental College and Hospital, S. P. Sahakar
Vidyadham, Ambaji Gandhinagar Link Road, Near Kamana Char
Rasta, Visnagar - 384315
Mahesana
GUJARAT
384315
India |
| Phone |
7708535361 |
| Fax |
|
| Email |
vshobaf@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Kavya R Shah |
| Designation |
Post Graduate Student |
| Affiliation |
Narsinhbhai Patel Dental College and Hospital |
| Address |
Narsinhbhai Patel Dental College and Hospital
Sankalchand Patel Vidyadham
Ambaji Gandhinagar Link Road
Near Kamana Char Rasta
Visnagar 384315
Narsinhbhai Patel Dental College and Hospital
Sankalchand Patel Vidyadham
Ambaji Gandhinagar Link Road
Near Kamana Char Rasta
Visnagar 384315
Mahesana
GUJARAT
384315
India |
| Phone |
7708535361 |
| Fax |
|
| Email |
kavshah04@gmail.com |
|
|
Source of Monetary or Material Support
|
| Narsinhbhai Patel Dental College and Hospital S P Sahakar Vidyadham Ambaji Gandhinagar Link Road Near Kamana Char Rasta Visnagar Gujarat 384315 |
|
|
Primary Sponsor
|
| Name |
Narsinhbhai Patel Dental College and Hospital |
| Address |
Narsinhbhai Patel Dental College and Hospital
Sankalchand Patel Vidyadham
Ambaji Gandhinagar Link Road
Near Kamana Char Rasta
Visnagar 384315 |
| Type of Sponsor |
Other [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 KAVYA SHAH |
Narsinhbhai Patel Dental College and Hospital |
Deaprtment of Pediatric and Preventive Dentistry
S P Sahakar Vidyadham Ambaji Gandhinagar Link Road Near Kamana Char Rasta Visnagar Gujarat 384315
Mahesana
GUJARAT |
7708535361
02765233008
kavshah04@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee of Narsinhbhai Patel Dental College and Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K040||Pulpitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Dexmedetomidine |
1.5µg/kg given Intranasally once at the beginning of the procedure
Duration of the procedure - 2 hours |
| Comparator Agent |
Midazolam |
0.5mg/kg, given Intranasally once at the beginning of the procedure
Duration of the procedure - 2 hours. |
|
|
Inclusion Criteria
|
| Age From |
4.00 Year(s) |
| Age To |
9.00 Year(s) |
| Gender |
Both |
| Details |
Patients undergoing treatment for the first time.
Patient who exhibit anxious behavior in Frankel behavior rating scale ( score 1 & 2)
Requiring two dental procedures under local anaesthesia.
|
|
| ExclusionCriteria |
| Details |
Patients who do not exhibit anxious behaviour on baseline anxiety scale.
Patients with any systemic disease or drug allergy.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Dexmedetomidine is a better anxiolytic and sedative agent than Midazolam |
Baseline, During procedure (45 mins) and After procedure (2 hours). |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Intranasal Dexmedetomidine is more effective than Midazolam |
Baseline, During procedure (45 mins) and After procedure (2 hours) |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "25"
Final Enrollment numbers achieved (India)="25" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
01/10/2022 |
| Date of Study Completion (India) |
30/11/2022 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
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 - YES
- 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).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
Response - Analytic Code
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [kavshah04@gmail.com].
- For how long will this data be available start date provided 01-09-2023 and end date provided 01-09-2027?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - nil
|
|
Brief Summary
|
This study is randomized controlled trial to compare the effectives of Midazolam and Dexmedetomidine as Sedative and Anxiolytic agent during dental procedures among 4 to 9 year old children utilizing split mouth technique. It would be conducted in Department of Pediatric and Preventive Dentistry at Narsinhbhai Patel Dental College & Hospital Visnagar Gujarat India. The primary outcome measures will be Dexmedetomidine is a better anxiolytic and sedative agent than Midazolam in children during dental procedures. The secondary outcome measures will be Intranasal Dexmedetomidine is more effective than Intranasal Midazolam.
|