| CTRI Number |
CTRI/2026/03/105323 [Registered on: 03/03/2026] Trial Registered Prospectively |
| Last Modified On: |
03/03/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Parent Experiences After Pediatric Dental Treatment Under General Anesthesia |
|
Scientific Title of Study
|
Parental Satisfaction Following Pediatric Dental Procedures Under Sevoflurane and Isoflurane General Anesthesia: A Comparative Randomized Controlled trial
|
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Rasika Pavan Chandak |
| Designation |
Post graduate student |
| Affiliation |
Saveetha dental college |
| Address |
clinic 28 , department of pediatrics and prevenetice dentistry , Saveetha Dental College, NH48, Chennai, TN, 600077
Chennai
TAMIL NADU
600077
India |
| Phone |
07038376379 |
| Fax |
|
| Email |
152411004.sdc@saveetha.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Rasika Pavan Chandak |
| Designation |
Post graduate student |
| Affiliation |
Saveetha dental college |
| Address |
clinic 28 , department of preventive and pediatric dentistry,Saveetha Dental College, NH48, Chennai, TN, 600077
Chennai
TAMIL NADU
600077
India |
| Phone |
07038376379 |
| Fax |
|
| Email |
152411004.sdc@saveetha.com |
|
Details of Contact Person
Public Query
|
| Name |
Rasika Pavan Chandak |
| Designation |
Post graduate student |
| Affiliation |
Saveetha dental college |
| Address |
clinic 28 , department of preventive and pediatric dentistry , Saveetha Dental College, NH48, Chennai, TN, 600077
Chennai
TAMIL NADU
600077
India |
| Phone |
07038376379 |
| Fax |
|
| Email |
152411004.sdc@saveetha.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Rasika Pavan Chandak |
| Address |
Saveetha dental college , chennai , 600077 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Rasika Pavan Chandak |
Saveetha dental college and hospital , SIMATS University |
Clinic 28 , Department of Preventive and Pediatric DentistrySaveetha Dental College, NH48, Chennai, TN, 600077
Chennai
TAMIL NADU |
07038376379
152411004.sdc@saveetha.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Saveetha Dental College - Institutional Human Ethical Committee (SDC-IHEC) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K029||Dental caries, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
isoflurane |
Children randomized to this group will receive general anesthesia induced and maintained with isoflurane via inhalational mask technique. Standard preoperative fasting guidelines will be followed. Anesthesia will be maintained with isoflurane in an oxygen/air mixture under standard intraoperative monitoring (heart rate, blood pressure, respiratory rate, and oxygen saturation). All planned dental procedures will be completed under standardized clinical conditions. |
| Intervention |
sevoflurane |
Children randomized to this group will receive general anesthesia induced and maintained with sevoflurane via inhalational mask technique. Standard preoperative fasting guidelines will be followed. Anesthesia will be maintained with sevoflurane in an oxygen/air mixture under standard intraoperative monitoring (heart rate, blood pressure, respiratory rate, and oxygen saturation). All planned dental procedures will be completed under standardized clinical conditions. |
|
|
Inclusion Criteria
|
| Age From |
3.00 Year(s) |
| Age To |
6.00 Year(s) |
| Gender |
Both |
| Details |
Children aged 3 to 6 years
Classified as ASA Physical Status 1 or 2
Requiring elective dental procedures under general anesthesia
Parents or legal guardians willing to provide written informed consent |
|
| ExclusionCriteria |
| Details |
Children with systemic illnesses (ASA 3 or above)
History of neurological disorders or developmental delays
Known allergy or hypersensitivity to inhalational anesthetic agents
Children with significant renal or hepatic impairment
Emergency dental procedures
Parents unwilling to provide consent |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Emergence agitation assessed using the Pediatric Anesthesia Emergence Delirium (PAED) Scale |
24 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Smoothness of emergence score
Time to spontaneous verbalization
Mask tolerance / induction behavior score
Ease of soothing (parent-reported Likert scale)
Spontaneous parent–child interaction
Time to first oral intake
Acceptance of oral intake
Overall parental satisfaction score
Satisfaction with recovery speed
Satisfaction with child comfort
Willingness to choose the same anesthetic agent again |
24 hours |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
14/03/2026 |
| 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="0"
Days="1" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
This randomized controlled trial aims to compare parental satisfaction following pediatric dental procedures performed under sevoflurane-based and isoflurane-based general anesthesia. Children requiring comprehensive dental treatment under general anesthesia will be randomly allocated to receive either sevoflurane or isoflurane for anesthetic maintenance. Standardized dental procedures will be performed under controlled clinical conditions. Parental satisfaction will be assessed postoperatively using a validated structured questionnaire evaluating domains such as child comfort, recovery characteristics, postoperative behavior, and overall experience. The study intends to determine whether the choice of inhalational anesthetic agent influences parental perception and satisfaction following pediatric dental treatment under general anesthesia. |