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CTRI Number  CTRI/2024/04/065765 [Registered on: 16/04/2024] Trial Registered Prospectively
Last Modified On: 16/04/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Dentistry
Behavioral 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Study on effect of nitrous oxide oxygen sedation techniques in children. 
Scientific Title of Study   Comparative evaluation of effectiveness of interrupted and continuous nitrous oxide oxygen sedation as administration technique in anxious children of 4 to 8 years of age- A 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  Dr Avani Ramesh Doiphode 
Designation  Postgraduate Student 
Affiliation  Government Dental College and Hospital, Nagpur 
Address  Room No - 108, Department of Paediatric and Preventive Dentistry, Government Dental College and Hospital, Medical Square, Hanuman Nagar, Nagpur.

Nagpur
MAHARASHTRA
440003
India 
Phone  9075725395  
Fax    
Email  avanidoiphode5@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Ritesh Kalaskar 
Designation  Professor and Head of the Department 
Affiliation  Government Dental College and Hospital, Nagpur 
Address  Room NO- 108, Department of Paediatric and Preventive Dentistry, Government Dental College and Hospital, Medical Square, Hanuman Nagar, Nagpur.

Nagpur
MAHARASHTRA
440003
India 
Phone  8550938585  
Fax    
Email  riteshpedo@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Ritesh Kalaskar 
Designation  Professor and Head of the Department 
Affiliation  Government Dental College and Hospital, Nagpur 
Address  Room NO- 108, Department of Paediatric and Preventive Dentistry, Government Dental College and Hospital, Medical Square, Hanuman Nagar, Nagpur.

Nagpur
MAHARASHTRA
440003
India 
Phone  8550938585  
Fax    
Email  riteshpedo@gmail.com  
 
Source of Monetary or Material Support  
Government dental college and hospital, Nagpur, Maharashtra, India. 440003 
 
Primary Sponsor  
Name  Dr Avani Ramesh Doiphode 
Address  Swamiraj Niwas, At post-Varse, Tal-Roha, Dist-Raigad, Maharashtra, India. 402109 
Type of Sponsor  Other [Self Sponsored] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Avani Ramesh Doiphode  Government Dental College and Hospital, Nagpur.  Room No- 108, Department of Paediatric and Preventive Dentistry.
Nagpur
MAHARASHTRA 
9075725395

avanidoiphode5@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Government Dental College and Hospital, Nagpur- Institutional ethical committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K042||Pulp degeneration,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Continuous Nitrous oxide oxygen (N2O-O2) sedation   Continuous N2O-O2 sedation administration technique involves initial administration of oxygen(O2) for 3 minutes, followed by administration of 50%-50% of O2 and nitrous oxide(N2O). The 50%-50% of N2O and O2 will be administered continuously till the end of complete planned treatment of pulpectomy which may approximately take around 45-50 minutes and at the end of treatment again administration of O2 for 5 minutes.  
Intervention  Interrupted Nitrous oxide oxygen (N2O-O2) sedation   In the case of mildly to moderately anxious children, interrupted N2O-O2 sedation administration technique involves initial administration of oxygen(O2) for 3 minutes, followed by administration of 50%-50% of O2 and nitrous oxide(N2O) for 5 minutes. Once profound local anesthesia has been established, it becomes possible to interrupt the continuous administration of N2O-O2 sedation while still effectively managing anxiety and maintaining desired behaviour. We assume that if behaviour issues related to local anesthetic administration alone have been successfully addressed, 100% oxygen may be administered and nitrous oxide will be stopped, offering a potential means of reducing chronic exposure of the dental team to potentially hazardous levels of ambient nitrous oxide and to reduce the chance of over sedation to patient. 
 
Inclusion Criteria  
Age From  4.00 Year(s)
Age To  8.00 Year(s)
Gender  Both 
Details  Children with ASA physical status classification I.
Patient with unilateral or bilateral carious first or second deciduous molar in need of treatment.
Children with anxiety score 3 or 4 on the Venhams anxiety scale.
Children with frankl behaviour rating of 3 or 4.
 
 
ExclusionCriteria 
Details  Children below age of 4 years of age and above 9 years of age
Children with ASA physical status classification II, III, IV.
Children with modified frankl’s behaviour rating scale 1 and 2.
Highly uncooperative children
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
1.Sedation level
 
Baseline, during the treatment and post-treatment.  
 
Secondary Outcome  
Outcome  TimePoints 
1.Psychomotor analysis
2. Behaviour of the patient 
Baseline, during treatment & post-treatment 
 
Target Sample Size   Total Sample Size="36"
Sample Size from India="36" 
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 
Date of First Enrollment (India)   01/07/2024 
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 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  

Nitrous oxide -oxygen conscious sedation (N2O- O2 sedation) is a commonly used technique in paediatric dentistry to manage anxiety and discomfort in patients undergoing dental procedures.This technique helps to reduce the physiological and psychological stress in anxious paediatric patients. Various benefits of using N2O- O2 sedation technique are its properties such as anxiolysis, mild analgesia, and amnesia.

 

Nevertheless, nitrous oxide poses a potential risk to clinical staff regularly administering inhalational sedation. There is substantiated evidence that prolonged exposure to nitrous oxide gas may result in hematological, reproductive, and neurological issues. Although the use of scavenging equipment, proper techniques, and well-ventilated surgical environments has notably reduced staff exposure levels, there remains some residual pollution within the surgical setting.

 

The traditional approach to N2O-O2 sedation involves the continuous administration of N2O- O2 throughout a dental procedure to ensure the ongoing cooperation of the patient. In the case of mildly to moderately anxious children, once profound local anesthesia has been established, it becomes possible to interrupt the continuous administration of N2O-O2 sedation while still effectively managing anxiety and maintaining desired behaviour. We assume that if behaviour issues related to local anesthetic administration alone have been successfully addressed, 100% oxygen may be administered, offering a potential means of reducing chronic exposure of the dental team to potentially hazardous levels of ambient nitrous oxide and to reduce the chance of over sedation to patient.

 

Hence, this study is planned to investigate the impact and sedation level achieved by interrupted N2O-O2 sedation administration, following the achievement of profound local anesthesia, on the physical, physiological, psychological parameters and behaviour of paediatric dental patients with mild to moderate anxiety during the rehabilitation of molars.

 
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