| CTRI Number |
CTRI/2024/06/068490 [Registered on: 06/06/2024] Trial Registered Prospectively |
| Last Modified On: |
03/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Effect of nitrous oxide inhalation sedation on childs anxiety and parental opinion during dental procedures |
|
Scientific Title of Study
|
Evaluation of efficacy of nitrous oxide inhalation sedation on childs anxiety and parental perception during dental procedures :A Randomised 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 |
Dr MATTA NAVYA |
| Designation |
POST GRADUATE STUDENT |
| Affiliation |
ANIL NEERUKONDA INSTITUTE OF DENTAL SCIENCES |
| Address |
ROOM NO 7,
DEPARTMENT OF PAEDIATRICS AND PREVENTIVE DENTISTRY,
ANIL NEERUKONDA INSTITUTE OF DENTAL SCIENCES,
SANGHIVALASA,
BHEEMUNIPATNAM,
VISAKHAPATNAM.
Visakhapatnam
ANDHRA PRADESH
531163
India |
| Phone |
8328330343 |
| Fax |
|
| Email |
navyanavimatta@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr .K.BALAKRISHNA |
| Designation |
MDS,PROFESSOR |
| Affiliation |
ANIL NEERUKONDA INSTITUTE OF DENTAL SCIENCES |
| Address |
ROOM NO 7,
DEPARTMENT OF PAEDIATRICS AND PREVENTIVE DENTISTRY,
ANIL NEERUKONDA INSTITUTE OF DENTAL SCIENCES,
SANGHIVALASA,
BHEEMUNIPATNAM,
VISAKHAPATNAM.
Visakhapatnam
ANDHRA PRADESH
531163
India |
| Phone |
9395354111 |
| Fax |
|
| Email |
kandarpa@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr MATTA NAVYA |
| Designation |
POST GRADUATE STUDENT |
| Affiliation |
ANIL NEERUKONDA INSTITUTE OF DENTAL SCIENCES |
| Address |
ROOM NO 7,
DEPARTMENT OF PAEDIATRICS AND PREVENTIVE DENTISTRY,
ANIL NEERUKONDA INSTITUTE OF DENTAL SCIENCES,
SANGHIVALASA,
BHEEMUNIPATNAM,
VISAKHAPATNAM.
Visakhapatnam
ANDHRA PRADESH
531163
India |
| Phone |
8328330343 |
| Fax |
|
| Email |
navyanavimatta@gmail.com |
|
|
Source of Monetary or Material Support
|
| ANIL NEERRUKONDA INSTITUTE OF DENTAL SCIENCES |
|
|
Primary Sponsor
|
| Name |
ANIL NEERUKONDA INSTITUTE OF DENTAL SCIENCES |
| Address |
ROOM NO 7,
DEPARTMENT OF PAEDIATRIC AND PREVENTIVE DENTISTRY,
ANIL NEERUKONDA INSTITUTE OF DENTAL SCIENCES,
SANGHIVALASA,
BHEEMUNIPATNAM,
VISAKHAPATNAM . |
| 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 MATTA NAVYA |
ANIL NEERUKONDA INSTITUTE OF DENTAL SCIENCES |
ROOM NO 7,
DEPARTMENT OF PEDIATRIC AND PREVENTIVE DENTISTRY,
ANIL NEERUKONDA INSTITUTE OF DENTAL SCIENCES,
SANGHIVALASA,
BHEEMUNIPATNAM,
VISAKHAPTNAM.
531163
Visakhapatnam
ANDHRA PRADESH |
8328330343
navyanavimatta@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE-ANIDS |
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 |
| Intervention |
Nitrous Oxide Inhalation Sedation |
Nitrous Oxide Inhalation Sedation (Con Sed, USA) |
| Comparator Agent |
Not Applicable |
Not Applicable |
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
11.00 Year(s) |
| Gender |
Both |
| Details |
Children under ASA I criteria
Anxious /phobic patients
Children with high fear susceptibility
Children with high gag reflex
Children with medical conditions aggravated by stress
|
|
| ExclusionCriteria |
| Details |
Children below 4 years of age .
Children with ASA II and above.
Children with respiratory tract infections
Children with Chronic Obstructive Pulmonary Disease.
Children with bowel obstruction or abdominal pain
Children with middle ear infections/otitis media .
Children with vitamin B 12 deficiency
Children undergoing treatment with bleomycin sulphate.
Children with psychiatric disorders..
Children underwent surgery involving anterior part of maxilla.
Children with mouth breathing habit.
Children who do not satisfy any of the above inclusion criteria
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Modified Dental Anxiety Scale Score |
Baseline and Post Operative |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Parental perception level regarding nitrous oxide treatment |
Immediately after procedure |
|
|
Target Sample Size
|
Total Sample Size="15"
Sample Size from India="15"
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 4 |
|
Date of First Enrollment (India)
|
22/07/2024 |
| 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="1"
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
|
|
A Randomised clinical trial
design including 15 children with either of their parents (15)will be
selected from outpatient Department of
Paediatrics and Preventive Dentistry of Anil Neerukonda Institute of Dental
Sciences .Children under inclusion criteria ( moderate to severe anxiety)
during 1st dental visit requiring dental treatment will be
included .The whole procedure will be explained to parents and are allowed to
watch a videotape regarding dental treatment done under nitrous oxide
sedation. Written informed consent will be taken from parents, then complete
case history will be recorded and dental procedures will be done under
nitrous oxide inhalation sedation. Pre and Post operative anxiety level of
patient will be evaluated with modified dental anxiety scale (MDAS). To
understand the parent perception
levels parent will be allowed to complete the questionnaire using likert
scale.
|
|