| CTRI Number |
CTRI/2023/07/055656 [Registered on: 25/07/2023] Trial Registered Prospectively |
| Last Modified On: |
25/07/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparing different methods to make receiving local anesthesia more comfortable and reduce anxiety. |
|
Scientific Title of Study
|
Comparative evaluation of cryotherapy, low level laser therapy and vibrating device for alleviating pain and anxiety during administration of local anesthesia using salivary cortisol levels: An Elisa based study |
| Trial Acronym |
not applicable |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Anusha Dixit |
| Designation |
post graduate student |
| Affiliation |
ITS-CDSR murad nagar ghaziabad |
| Address |
Its dental college, nh34 delhi meerut road, murad nagar ,ghaziabad
Ghaziabad
UTTAR PRADESH
201206
India |
| Phone |
9670725726 |
| Fax |
|
| Email |
AnushaDixit_MDS21_24@its.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Divya |
| Designation |
Reader |
| Affiliation |
ITS-CDSR murad nagar ghaziabad |
| Address |
Its dental college, nh34 delhi meerut road, murad nagar ,ghaziabad
Ghaziabad
UTTAR PRADESH
201206
India |
| Phone |
9459480501 |
| Fax |
|
| Email |
divyadoneria@its.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Anusha Dixit |
| Designation |
post graduate student |
| Affiliation |
ITS-CDSR murad nagar ghaziabad |
| Address |
Its dental college, nh34 delhi meerut road, murad nagar ,ghaziabad
Ghaziabad
UTTAR PRADESH
201206
India |
| Phone |
9670725726 |
| Fax |
|
| Email |
AnushaDixit_MDS21_24@its.edu.in |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Anusha dixit |
| Address |
I.T.S Dental College, Centre for Advanced Research, Muradnagar, Ghaziabad, 201206 |
| Type of Sponsor |
Other [self] |
|
|
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 Anusha dixit |
ITS-CDSR murad nagar |
room no 7, department of pediatrics and preventive dentistry, ITS dental college, nh34 delhi meerut road, muard nagar ghaziabad 201206
Ghaziabad
UTTAR PRADESH |
9670725726
AnushaDixit_MDS21_24@its.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Its institutional ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
healthy individuals |
| Patients |
(1) ICD-10 Condition: K029||Dental caries, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
behaviour modification technique |
cryotherpay, low-level laser therapy and vibrating device in reducing pain and anxiety during local anesthesia administration. 30-40 minutes |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
8.00 Year(s) |
| Gender |
Both |
| Details |
1. Children who require inferior alveolar nerve block
2.Five to Eight years old healthy children.
3. Frankl’s Behaviour rating scales III and IV. |
|
| ExclusionCriteria |
| Details |
1. No aversive experience about medical or dental treatment.
2. Children with allergy to local anaesthesia.
3. Children with systemic diseases, intellectual disability, psychiatric disorders and
dental abscesses or fistulas in the procedure site.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Effective pain control in children lays the foundation of successful behaviour management and hence the treatment. Thus, eliminating fear and anxiety of injections is of paramount importance in pediatric dentistry.
|
24hrs |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Topical Anesthesia, Cryotherapy, Vibrating device & Low-level laser therapy will be effective in reducing pain and anxiety during local anesthesia administration in children with or without statistical significant difference.
|
24hrs |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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)
|
30/08/2023 |
| 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="2"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
not yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The aim of the study is to
compare and evaluate the efficacy of topical anesthesia, Cryotherapy, Vibrating
device & Low-level laser therapy on alleviating pain and anxiety during
administration of Local Anesthesia. Informed consent will be obtained from
each subject’s parents before enrolling them in study. For each participant, at
least one parent/guardian will be informed about the procedure and will be
asked to sign the consent form. 80 subjects requiring any dental procedure will be selected and randomly assigned to one of the four groups. The four groups will be topical anesthesia, cryotherapy, low level laser therapy and vibrating device .Effective
pain control in children lays the foundation of successful behaviour management
and hence the treatment. Thus, eliminating fear and anxiety of injections is of
paramount importance in pediatric
dentistry.0
s |