| CTRI Number |
CTRI/2024/10/076021 [Registered on: 29/10/2024] Trial Registered Prospectively |
| Last Modified On: |
28/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
The effect of cooling the injection area on pain during local anesthesia |
|
Scientific Title of Study
|
Effect of precooling the injection site on pain perception prior to Local Anesthesia administration- An in vivo study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ridha Iqbal |
| Designation |
Post Graduate Student (MDS) |
| Affiliation |
I.T.S Dental College Hospital And Research Centre |
| Address |
Room No 7, Department Of Conservative Dentistry And
Endodontics, I.T.S Dental College, Knowledge Park 3, Greater Noida
Gautam Buddha Nagar
UTTAR PRADESH
201308
India |
| Phone |
9596951861 |
| Fax |
|
| Email |
ridhaiqbal5@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Manju Kumari |
| Designation |
Professor |
| Affiliation |
I.T.S Dental College Hospital And Research Centre |
| Address |
Room No 7, Department Of Conservative Dentistry And
Endodontics, I.T.S Dental College, Knowledge Park 3, Greater Noida
Gautam Buddha Nagar
UTTAR PRADESH
201308
India |
| Phone |
9811056881 |
| Fax |
|
| Email |
dr.manjukumari.dntl.gn@its.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Manju Kumari |
| Designation |
Professor |
| Affiliation |
I.T.S Dental College Hospital And Research Centre |
| Address |
Room No 7, Department Of Conservative Dentistry And
Endodontics, I.T.S Dental College, Knowledge Park 3, Greater Noida
Gautam Buddha Nagar
UTTAR PRADESH
201308
India |
| Phone |
9811056881 |
| Fax |
|
| Email |
dr.manjukumari.dntl.gn@its.edu.in |
|
|
Source of Monetary or Material Support
|
| Room No 7, Department Of Conservative Dentistry And Endodontics, I.T.S Dental College,
Knowledge Park 3, Greater Noida, Gautam Buddha Nagar, Uttar Pradesh, 201308, India |
|
|
Primary Sponsor
|
| Name |
ITS Dental College Hospital And Research Centre |
| Address |
Room No 7, Department Of Conservative Dentistry And
Endodontics, I.T.S Dental College, Knowledge Park 3, Greater
Noida, Gautam Buddha Nagar, Uttar Pradesh, 201308, India |
| 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 Ridha Iqbal |
I.T.S Dental College, Hospital And Research Centre |
Room No 7,
Department Of
Conservative Dentistry
And Endodontics,
Knowledge Park 3,
Greater Noida, 201308
Gautam Buddha Nagar
UTTAR PRADESH |
9596951861
ridhaiqbal5@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| I.T.S Dental college hospital and research centre 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 |
Topical ice application for
1 min
|
ice stick will be applied at the site of injection for 1 minute prior to administration of Local Anesthesia. VAS scale will be used to evaluate the intensity of pain experienced by the patients on a scale of 0-10.
|
| Intervention |
Topical ice application for
2 min
|
ice stick will be applied at the site of injection for 2 minutes prior to administration of Local Anesthesia. VAS scale will be used to evaluate the intensity of pain experienced by the patients on a scale of 0-10. |
| Comparator Agent |
Topical local anaesthesia application
|
topical local anesthesia spray will be applied at the site of injection prior to administration of Local Anesthesia. VAS scale will be used to evaluate the intensity of pain experienced by the patients on a scale of 0-10. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1.Adult patients above 18 years of age without any systemic disease and no mental health disorders.
2.Patients diagnosed with symptomatic irreversible pulpitis (SIP) planned for endodontic treatment in mandibular molars requiring inferior alveolar nerve block.
|
|
| ExclusionCriteria |
| Details |
1.Neural disorders
2.Participants who refuse to take part in this study.
3.Patients on analgesics and antibiotics within past month
4.Patients with systemic diseases like diabetes and hypertension
5.Any allergy to local anesthesia
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To compare the effect of ice application at 1 and 2 minutes on pain perception during intraoral injection.
|
1 min and 2 min |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To evaluate the effect of ice application at 1 and 2 minutes on pain perception during intraoral injection.
|
1 min and 2 min |
|
|
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
10/11/2024 |
| 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="2"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
The study will be done to
evaluate and compare the effect of ice application at 1 and 2 minutes on pain
perception during intraoral injection. The forthcoming clinical study will be carried out within the Department of Conservative Dentistry and Endodontics at I.T.S. Dental College, Hospital, and Research Centre in Greater Noida, Uttar Pradesh. The sample size for the study will
encompass a total of 150 patients drawn from the Outpatient Department (O.P.D) of the Department of Conservative Dentistry and Endodontics, adhering meticulously to predefined inclusion and exclusion criteria. If a patient met all the inclusion criteria, he/she will be informed of the nature of the study and will be invited to
participate by signing the consent forms. Patients will be then allocated to 3 groups of 50 patients each receiving topical local anesthesia spray, topical ice application for 1 min and topical ice application for 2 min prior to local anesthesia administration. VAS scale will be used to evaluate the intensity of pain experienced by the patients on a scale of 1-10
|