| CTRI Number |
CTRI/2025/03/082298 [Registered on: 13/03/2025] Trial Registered Prospectively |
| Last Modified On: |
12/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
|
| Study Design |
Other |
|
Public Title of Study
|
Assessment of Efficacy and Brain Activity of Oral Sedation versus Nitrous Oxide Sedation in Paediatric Patients A Comparative Study |
|
Scientific Title of Study
|
Assessment of Efficacy and Brain Activity of Oral Midazolam Sedation versus Nitrous Oxide Sedation in Paediatric Patients A Comparative Study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Neha Ghongade |
| Designation |
Post graduate student |
| Affiliation |
Krishna Vishwa Vidyapeeth Karad |
| Address |
School of dental sciences KVV Karad Department of Pediatric and Preventive dentistry Department number 42
Satara
MAHARASHTRA
415110
India |
| Phone |
7030421199 |
| Fax |
|
| Email |
nrghongade13@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Namrata Gaonkar |
| Designation |
Associate Professor |
| Affiliation |
Krishna Vishwa Vidyapeeth Karad |
| Address |
School of dental sciences KVV Karad
Satara
MAHARASHTRA
415110
India |
| Phone |
7030421199 |
| Fax |
|
| Email |
namrata_gaonkar@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Neha Ghongade |
| Designation |
Post graduate student |
| Affiliation |
Krishna Vishwa Vidyapeeth Karad |
| Address |
School of dental sciences KVV Karad Department of Pediatric and Preventive Dentistry Department number 42
Satara
MAHARASHTRA
415110
India |
| Phone |
7030421199 |
| Fax |
|
| Email |
nrghongade13@gmail.com |
|
|
Source of Monetary or Material Support
|
| Krishna Vishwa Vidyapeeth Karad 415110 District Satara State Maharashtra |
|
|
Primary Sponsor
|
| Name |
Krishna Vishwa Vidyapeeth Karad |
| Address |
School of dental sciences KVV Karad 415110 Maharashtra |
| Type of Sponsor |
Private medical 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 Neha Ghongade |
School of dental sciences Krishna Vishwa Vidyapeeth Karad |
Krishna Vishwa Vidyapeeth Malkapur Karad 415110 Maharashtra
Satara
MAHARASHTRA |
7030421199
nrghongade13@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Krishna Vishwa Vidyapeeth Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Children undergoing pulpectomy treatment |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Oral midazolam and nitrous oxide gas |
Children undergoing pulpectomy treatment will be subjected to oral sedation using oral midazolam on the first appointment and nitrous oxide sedation on the second appointment using the inhalational route on consecutive appointments and brain activity will be recorded using electroencephalograph and comparative analysis will be done |
|
|
Inclusion Criteria
|
| Age From |
4.00 Year(s) |
| Age To |
10.00 Year(s) |
| Gender |
Both |
| Details |
Children aged from 4 to 10 years undergoing dental treatment |
|
| ExclusionCriteria |
| Details |
Patients with systemic condition physical disability mental retardation |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 1 year |
6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 1 year |
1 year |
|
|
Target Sample Size
|
Total Sample Size="14"
Sample Size from India="14"
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)
|
25/03/2025 |
| 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="6"
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
|
Pediatric dentistry aims to provide comprehensive oral healthcare to children including those who may require sedation to ensure a safe and anxiety free dental experience. Sedation techniques play a crucial role in managing fear and anxiety in pediatric patients allowing for successful dental treatments Two commonly employed sedation methods in pediatric dentistry are oral sedation and nitrous oxide sedation However a comprehensive understanding of their efficacy and impact on brain activity is essential for optimizing dental care for children The present study focuses on assessing the efficacy and brain activity associated with oral sedation versus nitrous oxide sedation in pediatric patients The study aims to contribute valuable insights into the effectiveness of these sedation modalities aiding clinicians in making informed decisions regarding sedation techniques for pediatric dental procedures Dental Anxiety in Pediatric Patients Pediatric dental anxiety is a significant concern that can hinder the delivery of essential dental care to children Unaddressed dental anxiety can lead to avoidance behaviors compromised oral health and negative long-term dental experiences To mitigate these challenges sedation techniques are employed to help children relax and feel comfortable during dental treatment Oral Sedation Oral sedation involves administering sedative medications orally to induce a state of relaxation and reduced anxiety in pediatric patients Medications such as benzodiazepines are commonly used which act on the central nervous system promoting sedation and reducing anxiety However the effectiveness and potential adverse effects of oral sedation require careful evaluation Nitrous Oxide Sedation Nitrous oxide also known as laughing gas is a safe and commonly used inhalation sedative in pediatric dentistry Nitrous oxide produces anxiolysis mild sedation and analgesia making it a popular choice for managing dental anxiety in children However a comprehensive assessment of its efficacy and impact on brain activity is crucial to determine its suitability for various pediatric patients
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