| CTRI Number |
CTRI/2024/05/067040 [Registered on: 08/05/2024] Trial Registered Prospectively |
| Last Modified On: |
07/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia
Dentistry |
| Study Design |
Randomized, Crossover Trial |
|
Public Title of Study
|
to check the pain perception of local anesthetics when the injection site is precooled with ice in patients requiring restorative or endodontic treatment of upper left and right molars. |
|
Scientific Title of Study
|
Effect of pre-cooling injection site on pain perception during injection of local anesthetic in maxillary molars: a randomized 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 |
F Rizwan Ahmed |
| Designation |
Post graduate student |
| Affiliation |
COORG INSTITUTE OF DENTAL SCIENCES |
| Address |
Room no 07, Department of Conservative Dentistry and Endodontics, Coorg Institute of Dental Sciences, Virajpet, Kodagu, Karnataka, India - 571218.
Room no 07, Department of Conservative Dentistry and Endodontics, Coorg Institute of Dental Sciences, Virajpet, Kodagu, Karnataka, India - 571218.
Kodagu
KARNATAKA
571218
India |
| Phone |
07019249337 |
| Fax |
|
| Email |
rizwan8585@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR Girish T N |
| Designation |
Professor |
| Affiliation |
Coorg Institute of Dental Sciences |
| Address |
Room no 07, Department of Conservative Dentistry and Endodontics, Coorg Institute of Dental Sciences, Virajpet, Kodagu, Karnataka, India - 571218.
Room no 07, Department of Conservative Dentistry and Endodontics, Coorg Institute of Dental Sciences, Virajpet, Kodagu, Karnataka, India - 571218.
Kodagu
KARNATAKA
571218
India |
| Phone |
9845305950 |
| Fax |
|
| Email |
drgirishtn@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
F Rizwan Ahmed |
| Designation |
Post graduate student |
| Affiliation |
Coorg Institute of Dental Sciences |
| Address |
Department of Conservative dentistry and Endodontics, Coorg Institute of Dental Sciences, Virajpet, Kodagu, Karnataka - 571218
Coorg Institute of Dental Sciences, Maggula village, Virajpet, Kodagu - 571218
Kodagu
KARNATAKA
571218
India |
| Phone |
07019249337 |
| Fax |
|
| Email |
rizwan8585@gmail.com |
|
|
Source of Monetary or Material Support
|
| Coorg Institute of Dental Sciences, Virajpet, Kodagu, Karnataka, India - 571218. |
|
|
Primary Sponsor
|
| Name |
DR F RIZWAN AHMED |
| Address |
Room no 07, Department of Conservative Dentistry and Endodontics, Coorg Institute of Dental Sciences, Virajpet, Kodagu, Karnataka, India - 571218. |
| Type of Sponsor |
Other [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 F RIZWAN AHMED |
coorg institute of dental sciences |
Department number 07, department of conservative dentistry and endodontics.
Kodagu
KARNATAKA |
7019249337
rizwan8585@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional review board , coorg institute of dental sciences |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
application of anesthetic gel on injection site prior to administration of anesthetic agent. |
Apply anesthetic gel to the injection site before administering 1 mL of local anesthesia, which consists of 2% lignocaine hydrochloride with a 1:80,000 concentration of epinephrine. |
| Intervention |
application of ice prior to local anesthetic injection |
Precooling of the injection site shall be done with ice stick for 15 sec followed by 1 mL of local anesthesia (2% lignocaine hydrochloride with 1:80,000 epinephrine) administration. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients with good health in the age group of 18-50 years.
2.Patients scheduled to receive treatment of maxillary first and second molars for either Restorative or Endodontic treatment.
3.Patients with preoperative pain score 0-85mm as measured on HP-VAS scale.
|
|
| ExclusionCriteria |
| Details |
Individuals with systemic and mental illness.
Individuals with known allergy or contraindication to lignocaine.
Pregnant and lactating mothers.
Individuals who have taken analgesics 12hrs before endodontic procedure.
Individuals under barbiturates and benzodiazepine medication.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
|
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| reduction in pain when injection site is precooled prior to the injection of the local anesthetic. |
the data will be measured based on the HP-VAS score before and after intervention. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| compare the effect of lignocaine gel in comparison to precooling of the anesthetic site prior to injection of the local anesthetic agent. |
the data will be measured based on the HP-VAS score before and after intervention. |
|
|
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 1 |
|
Date of First Enrollment (India)
|
27/05/2024 |
| 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="3"
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 total of 15 participants who are
scheduled to receive treatment of maxillary first and second molars for either Restorative
or Endodontic treatment, will be
included in this study, after obtaining ethical clearance and informed consent.
Case history shall be recorded and clinical and radiographic examination will
be performed to confirm the need for treatment. The selective patients will be
taken up for a split mouth study:
· Group 1: Control
· Group 2: Experimental
Group I: Control side - 2% lignocaine anesthetic gel will
be applied and after 1min, 1 mL of local anesthesia (2% lignocaine hydrochloride with
1:80,000 epinephrine) at room
temperature will be administered via buccal infiltration.
Group II: Trial Side - Precooling of the injection
site shall be done with ice stick for 15 sec
followed by 1 mL of local anesthesia (2% lignocaine hydrochloride with 1:80,000 epinephrine) administration.
Patients would then be instructed
to rate the pain following administration of local anesthesia using HP-VAS
which would be recorded as pain on injection. |