| CTRI Number |
CTRI/2024/06/068349 [Registered on: 05/06/2024] Trial Registered Prospectively |
| Last Modified On: |
04/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized Factorial Trial |
|
Public Title of Study
|
Impact of Dentists Facial appearance on children |
|
Scientific Title of Study
|
Influence of Dentists facial appearance on children: A randomized control 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 Keval Vayeda |
| Designation |
Post graduate student |
| Affiliation |
College of Dental science and Hospital, Amargadh,Bhavnagar,Gujarat. |
| Address |
Department of pediatric and preventive dentistry, Division P, Room
No 6, College of Dental Science and Hospital, Bhavnagar Rajkot
Highway, Amargadh Tal- Sihor, Dist- Bhavnagar GUJARAT 364210
Bhavnagar
GUJARAT
380052
India |
| Phone |
07984868134 |
| Fax |
|
| Email |
kevalvayeda16@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shital Kiran D P |
| Designation |
Professor and Head of Department in Pediatric and preventive dentistry |
| Affiliation |
College of Dental Sciences Gujarat |
| Address |
Department of pediatric and preventive dentistry, Division P, Room No 6, College of Dental Science and Hospital, Amargadh Tal- Sihor, Dist- Bhavnagar GUJARAT 364210
India
Bhavnagar
GUJARAT
364210
India |
| Phone |
7016310949 |
| Fax |
|
| Email |
drskiran@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shital Kiran D P |
| Designation |
Professor and Head of Department in Pediatric and preventive dentistry |
| Affiliation |
College of Dental Sciences Gujarat |
| Address |
Department of pediatric and preventive dentistry, Division P, Room No 6, College of Dental Science and Hospital, Amargadh Tal- Sihor, Dist- Bhavnagar GUJARAT 364210
India
Bhavnagar
GUJARAT
364210
India |
| Phone |
7016310949 |
| Fax |
|
| Email |
drskiran@gmail.com |
|
|
Source of Monetary or Material Support
|
| College of Dental Sciences,Amargadh Bhavnagar 364210 |
|
|
Primary Sponsor
|
| Name |
College of Dental Science Amargadh Bhavnagar |
| Address |
College of Dental Sciences Amargadh Bhavnagar 364210 |
| 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 |
| KEVAL N VAYEDA |
College of Dental Sciences,Amargadh |
Department of pediatric and preventive dentistry, Division P, Room No 6, College of Dental Science and Hospital, Bhavnagar Rajkot Highway, Amargadh Tal- Sihor, Dist- Bhavnagar GUJARAT 364210
Bhavnagar
GUJARAT |
07984868134
kevalvayeda16@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K040||Pulpitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Moustache and Bearded (Natural or artificial) male dentist |
children will be treated with the help of male dentist having moustache and bearded male dentist (Natural or artificial) under going treatment which required local anesthesia.Immideately after starting the treatment |
| Comparator Agent |
Non moustache and non -bearded male dentist |
children will be treated with the help of male dentist who is not having moustache and beard under going treatment which required local anesthesia. Immediately after starting the treatment |
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
1)Patient of both gender aged 6-12 years
2)Parents who give the consent
3)Any treatment which require local anesthesia (Infiltration)
|
|
| ExclusionCriteria |
| Details |
1)Children who are medically and physically compromised |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Assessment of pulse rate before the
administration of local anesthesia |
Before the procedure which require local anesthesia. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Assessment of anxiety Immediately after starting the procedure
of local anesthesia
|
Immediately after starting the procedure which require administration of local anaesthesia
|
|
|
Target Sample Size
|
Total Sample Size="32"
Sample Size from India="32"
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)
|
17/06/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
17/06/2024 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="2"
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 randomized control trial will be conducted on 32 number of children of age group
6- 12 years who will be reporting to the department of pediatric dentistry and
indicated for the treatment of procedures which require local anesthesia (infiltration)
will randomly be allocated to two different groups with the help of block
randomization method. A written informed consent will be taken from the
parents/guardian.
•
Group 1 (Control group) – Non
moustache and non -bearded male dentist •
Group 2 (Experimental group) –
Moustache and Bearded (Natural or artificial) male dentist •
In group 1, children will be
treated with the help of male dentist who is not having moustache and
beard under going treatment which
required local anesthesia. •
In group 2, children will be
treated with the help of male dentist having
moustache and bearded male dentist (Natural or artificial) under going
treatment which required local anesthesia.
Anxiety of the subjects will be assessed before
the procedure and after the procedure with the help of pulse oximeter and
Raghavendra, Madhuri, Sujata pictorial scale (RMS -PS) in both the groups |