| CTRI Number |
CTRI/2025/03/082183 [Registered on: 12/03/2025] Trial Registered Prospectively |
| Last Modified On: |
24/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Homeopathy
Dentistry
Behavioral |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Assessment of anxiolytic effect of Homeopathy medicine and nitrous oxide inhalation sedation in pediatric patient during dental procedure |
|
Scientific Title of Study
|
Comparative Assessment Of Anxiolytic Effect Of Homeopathy Medicine and Nitrous Oxide Oxygen Inhalation Sedation In Children |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Vaidehi Patel |
| Designation |
Post Graduate Student |
| Affiliation |
College of dental sciences and research centre |
| Address |
College of dental sciences and research center, near navneet printing press, opposite pleasure club, 380058
Ahmadabad
GUJARAT
380058
India |
| Phone |
09638847747 |
| Fax |
|
| Email |
vaidehipatel2151@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Anup Kumar Panda |
| Designation |
PG Guide, Professor, HOD |
| Affiliation |
College of dental sciences and research centre |
| Address |
B- 1003/1004 Sai Sanskar Punjabwadi, Deonar Sion Trombay Road, Mumbai, Maharastra
Mumbai
MAHARASHTRA
400088
India |
| Phone |
09727800006 |
| Fax |
|
| Email |
dranuppanda76@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Vaidehi Patel |
| Designation |
Post Graduate Student |
| Affiliation |
College of dental sciences and research centre |
| Address |
College of dental sciences and research center, near navneet printing press, opposite pleasure club, 380058
GUJARAT
380058
India |
| Phone |
09638847747 |
| Fax |
|
| Email |
vaidehipatel2151@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr. Vaidehi Patel College of dental sciences and research centre, near navneet printing press, opposite pleasure club, bopal, Ahmedabad, Gujarat, 380058 |
|
|
Primary Sponsor
|
| Name |
Dr Vaidehi Piyushbhai Patel |
| Address |
College of dental sciences and research centre, bopal, Ahmedabad,Gujarat - 380058 |
| 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 Vaidehi Piyushbhai Patel |
College of dental sciences and research centre |
Department number 9, second floor, College of dental sciences and research center, near navneet printing press, opposite pleasure club, 380058
Ahmadabad
GUJARAT |
09638847747
vaidehipatel2151@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| college of dental sciences and research centre, bopal, Ahmedabad |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
, (1) ICD-10 Condition: F989||Unspecified behavioral and emotional disorders with onset usually occurring in childhood and adolescence, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Aconitum Napellus |
Aconitim Napellus Homeopathy Medicine given orally 30 minute prior to the dental procedure |
| Comparator Agent |
Nitrous oxide inhalation sedation |
Nitrous oxide inhalation sedation is given to the children during local anesthesia |
|
|
Inclusion Criteria
|
| Age From |
4.00 Year(s) |
| Age To |
8.00 Year(s) |
| Gender |
Both |
| Details |
Children aged between 4-8 years with no previous dental experience and whose behaviour fall into FRANKL negative (-) behaviour rating scale were included
|
|
| ExclusionCriteria |
| Details |
1. Children with any medical history
2. Children with special health care needs
3. FRANKL definitely negative(--), definitely positive behaviour(++), positive(+)
4. Not ready to give written informed consent were excluded |
|
|
Method of Generating Random Sequence
|
Adaptive randomization, such as minimization |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate Anxiolytic efficacy of aconitum napellus homeopathy medicine |
6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare anxiolytic effectiveness of aconitum napellus homeopathy medicine and nitrous oxide inhalation sedation |
6 months |
|
|
Target Sample Size
|
Total Sample Size="150"
Sample Size from India="150"
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)
|
17/03/2025 |
| 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) |
Open to Recruitment |
|
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
|
Comparative
assessment of anxiolytic effect of different agents in children during administration
of local anesthesia
Abstract
Introduction:
Anxiety
among paediatric patient is one of the most common problems encountered in the
dental operatory which is also a challenge for the paediatric dentist. Among
the various available antianxiety medicines in which homeopathy is a safe and
natural alternative to conventional drug which is proved to be effective in
both children and adult. Homeopathic medicines are used in paediatric dentistry
to improve the psychological or emotional condition of patients without any
side effects. Nitrous oxide (N2O) and oxygen
(O2) have been recommended by the American Academy of Pediatric Dentistry as
the optimal approach for uncooperative or anxious patients.
Aim:
The
aim of the study is to compare anxiolytic efficacy of homeopathic medicine
Aconitum Napellus CM and nitrous oxide inhalation sedation in children during
dental procedures.
Objectives:
To
check anxiolytic efficacy of homeopathy medicine Aconitum Napellus CM
Materials
and methods:
3
to 8 years old children with no prior dental experience and requiring dental
treatment are randomly divided into nitrous oxide inhalation sedation (group A)
homeopathy medicine aconitum napellus CM (group B) and nitrous oxide inhalation
sedation + homeopathy medicine aconitum napellus CM (group C) who were
systemically healthy were included in the study.
Result:
Statistically
analysed
Conclusion:
To be awaited
|