| CTRI Number |
CTRI/2024/05/066652 [Registered on: 02/05/2024] Trial Registered Prospectively |
| Last Modified On: |
02/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To compare two methods of using laughing gas for relaxation in children during dental treatment |
|
Scientific Title of Study
|
Comparative Evaluation of Two Different Induction Techniques of Nitrous Oxide Sedation – A Randomized Clinical 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 |
HADEEL FAROOQ |
| Designation |
Postgraduate student |
| Affiliation |
Manav Rachna Dental College |
| Address |
Q Block, Basement-Room 9,Department of Pediatric and Preventive Dentistry, Manav Rachna Dental College , Sector 43 , Faridabad, Haryana
Q Block, Basement-Room 9,Department of Pediatric and Preventive Dentistry, Manav Rachna Dental College , Sector 43 , Faridabad, Haryana
Faridabad
HARYANA
121004
India |
| Phone |
7303904867 |
| Fax |
|
| Email |
Hadeelfarooq797@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR TANU NANGIA |
| Designation |
PROFESSOR |
| Affiliation |
Manav Rachna Dental College |
| Address |
Q Block, Basement-Room 9,Department of Pediatric and Preventive Dentistry, Manav Rachna Dental College , Sector 43 , Faridabad, Haryana
Q Block, Basement-Room 9,Department of Pediatric and Preventive Dentistry, Manav Rachna Dental College , Sector 43 , Faridabad, Haryana
Faridabad
HARYANA
121004
India |
| Phone |
9999384333 |
| Fax |
|
| Email |
tanunangia.sds@mrei.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
DR TANU NANGIA |
| Designation |
PROFESSOR |
| Affiliation |
Manav Rachna Dental College |
| Address |
Q Block, Basement-Room 9,Department of Pediatric and Preventive Dentistry, Manav Rachna Dental College , Sector 43 , Faridabad, Haryana
Q Block, Basement-Room 9,Department of Pediatric and Preventive Dentistry, Manav Rachna Dental College , Sector 43 , Faridabad, Haryana
HARYANA
121004
India |
| Phone |
9999384333 |
| Fax |
|
| Email |
tanunangia.sds@mrei.ac.in |
|
|
Source of Monetary or Material Support
|
| Q Block, Basement-Room 9,Department of Pediatric and Preventive Dentistry, Manav Rachna Dental College , Sector 43 , Faridabad, Haryana |
|
|
Primary Sponsor
|
| Name |
Not Applicable |
| Address |
Not Applicable |
| Type of Sponsor |
Other [Not Applicable] |
|
|
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 Hadeel Farooq |
Manav Rachna Dental College |
Q Block, Basement-Room 9,Department of Pediatric and Preventive Dentistry, Manav Rachna Dental College , Sector 43 , Faridabad, Haryana - 121004
Faridabad
HARYANA |
7303904867
hadeelfarooq797@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Manav Rachna Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Dental pulp[al therapy |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nitrous oxide sedation (rapid titration) |
Rapid titration induction technique using nitrous oxide oxygen sedation in the ratio 50:50 to be given for 30 minutes and study period is 12 months
|
| Comparator Agent |
Nitrous oxide sedation (slow titration) |
Slow titration induction technique using nitrous oxide oxygen sedation in different concentrations (10,20,30,40,50) to be given for 30 minutes and study period is 12 months
|
|
|
Inclusion Criteria
|
| Age From |
4.00 Year(s) |
| Age To |
8.00 Year(s) |
| Gender |
Both |
| Details |
Children aged 4-8 years
Frankl’s Behavior Rating 2 (negative), 3 (positive)
ASA I category children
Primary teeth indicated for vital pulp therapy
Children with no previous experience of intraoral local anesthesia
Children whose parent / guardian gives written consent for the procedure
|
|
| ExclusionCriteria |
| Details |
Children with upper respiratory tract infection
Children with blocked nose
Patient with extraoral and intraoral swellings
Patient with any systemic disease
Children with special healthcare needs
Children allergic to local anaesthetic agent (after test dose)
|
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare and evaluate the differences in salivary cortisol levels, physiological psychomotor parameters and analgesic effects between the rapid and slow titration induction techniques |
base line and post sedation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To evaluate the pre & post-op physiological parameters when using the rapid titration induction technique
To evaluate the pre & post-op salivary cortisol levels when using the rapid titration induction technique
To evaluate the pre & post-op psychomotor parameters when using the rapid titration induction technique
To evaluate the pre & post-op analgesic effects when using the rapid titration induction technique
To evaluate the pre & post-op physiological parameters when using the slow titration induction technique
To evaluate the pre & post-op salivary cortisol levels when using the slow titration induction technique
To evaluate the pre & post-op psychomotor parameters when using the slow titration induction technique
To evaluate the pre & post-op analgesic effects when using the slow titration induction technique
|
baseline & post sedation |
|
|
Target Sample Size
|
Total Sample Size="84"
Sample Size from India="84"
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
|
Phase 3/ Phase 4 |
|
Date of First Enrollment (India)
|
15/05/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
15/05/2024 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
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
|
Nitrous oxide (N2O) is a recognized method in pediatric dentistry for reducing anxiety and enhancing communication. It can be administered rapidly in uncooperative children or slowly with gradual concentration increases. Anxiety triggers the release of cortisol through the hypothalamic-pituitary-adrenal (HPA) axis and sympathetic nervous system. The American Academy of Pediatric Dentistry (AAPD) acknowledges N2O’s efficacy in reducing anxiety levels and facilitating effective patient-doctor communication. This method offers a safe and effective approach to managing anxiety in pediatric patients, allowing for improved cooperation during dental procedures.The aim of this study is to compare and evaluate the variations in physiological, psychomotor parameters and analgesic effects in 4–8-year-old children undergoing pulpal therapy under nitrous oxide sedation using two different induction techniques. The patient will be made to sit on the dental chair and will be examined under a strict sterilization protocol. The patient’s behavior will be assessed according to the Frankl’s behavior rating scale following which the pre-op saliva would be collected – approx. 1ml and physiological, psychomotor parameters and analgesic effects will be recorded . Then the nitrous oxide sedation would be initiated as per the nitrous oxide induction protocol and the induction technique will be based on the randomized block design. Administration of the local anesthetic agent and the pulp therapy procedure will be carried out. After induction, the salivary sample will be recollected and all the other parameters will be re recorded.The samples will be sent for salivary biomarker level analysis to the microbiology lab . |