CTRI

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CTRI Number

CTRI/2024/04/065545 [Registered on: 10/04/2024] Trial Registered Prospectively

Last Modified On:

20/10/2024

Post Graduate Thesis

Yes

Type of Trial

Interventional

Type of Study

Drug
Dentistry

Study Design

Randomized, Parallel Group, Active Controlled Trial

Public Title of Study

Comparing the pain on injection and pain during root canal treatment on giving normal and cold injection

Scientific Title of Study

Effect of topical cooling of the injection site and cold anesthetic administration on onset, anesthetic efficacy and injection pain during infiltration anesthesia of maxillary premolars with symptomatic irreversible pulpitis: A randomized controlled 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	ANJITHA T
Designation	POST GRADUATE STUDENT
Affiliation	Coorg institute of dental sciences
Address	Coorg institute of dental sciences Department of conservative dentistry and endodontics Room no:7 KK campus Maggula village Virajpet Kodaku Karnataka Coorg institute of dental sciences Department of conservative dentistry and endodontics room no:7 Maggula village Virajpet Kodaku Karnataka Kodagu KARNATAKA 571218 India
Phone	8137926699
Fax
Email	anjithat96@gmail.com

Details of Contact Person
Scientific Query

Name	Dr KC Ponnappa
Designation	Professor and HOD
Affiliation	Coorg institute of dental sciences
Address	Coorg institute of dental sciences Department of conservative dentistry and endodontics Room no :7 KK campus Maggula village Karnataka Coorg institute of dental sciences Department of conservative dentistry and endodontics Room no :7 KK campus Maggula village Karnataka Kodagu KARNATAKA 571218 India
Phone	9449764068
Fax
Email	drponnappa@gmail.com

Details of Contact Person
Public Query

Name	ANJITHA T
Designation	Post graduate student
Affiliation	Coorg institute of dental sciences
Address	Coorg institute of dental sciences Department of conservative dentistry and endodontics Room no:7 KK campus Maggula village Virajpet Kodaku Karnataka Coorg institute of dental sciences Department of conservative dentistry and endodontics Room no:7 KK campus Maggula village Virajpet Kodaku Karnataka Kodagu KARNATAKA 571218 India
Phone	8137926699
Fax
Email	anjithat96@gmail.com

Source of Monetary or Material Support

Coorg institute of dental sciences Department of conservative dentistry and endodontics Room no:7 KK campus Maggula village Virajpet Kodaku Karnataka

Primary Sponsor

Name	ANJITHA T
Address	Coorg institute of dental sciences Department of conservative dentistry and endodontics Room no:7 KK campus Maggula village Virajpet Kodaku Karnataka
Type of Sponsor	Other [[self]]

Details of Secondary Sponsor

Name	Address
NIL	NIL

Countries of Recruitment

India

Sites of Study

No of Sites = 1
Name of Principal Investigator	Name of Site	Site Address	Phone/Fax/Email
Dr ANJITHA T	Coorg institute of dental sciences	Department of conservative dentistry and endodontics Room no:7 KK campus Maggula village Virajpet Kodaku Karnataka Kodagu KARNATAKA	8137926699 anjithat96@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

Status

Not Applicable

Health Condition / Problems Studied

Health Type	Condition
Patients	(1) ICD-10 Condition: K040\|\|Pulpitis,

Intervention / Comparator Agent

Type	Name	Details
Comparator Agent	2% lignocaine HCl with 1:80,000 epinephrine	Applying 2% lignocaine gel on injection site followed by administration of 2% lignocaine HCl with 1:80,000 epinephrine and evaluating pain on injection ,onset of anesthesia and anesthetic efficacy in maxillary premolars.
Intervention	cold 2% lignocaine HCl with 1:80,000 epinephrine	One time intervention by applying ice stick over injection site and administration of cold 2% lignocaine HCl with 1:80,000 epinephrine and evaluation of onset, anesthetic efficacy and pain on injection during infiltration anesthesia in maxillary premolars.

Inclusion Criteria

Age From	20.00 Year(s)
Age To	40.00 Year(s)
Gender	Both
Details	.Patients with good health in the age group of 20-40 years. 2.Patients with symptomatic irreversible pulpitis of maxillary premolars. 3.Patients with preoperative pain score greater than 54mm 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.
Presence of chronic endodontic lesions in relation to the tooth.

Method of Generating Random Sequence

Computer generated randomization

Method of Concealment

Other

Blinding/Masking

Not Applicable

Primary Outcome

Outcome	TimePoints
Evaluate the onset, anesthetic efficacy and injection pain during administration of cold local anesthesia.	Evaluate the onset, anesthetic efficacy and injection pain during administration of cold local anesthesia at the baseline.

Secondary Outcome

Outcome	TimePoints
Intergroup comparison of the effects of the anesthesia.	Compare the effect of anesthesia in males & females at the baseline.

Target Sample Size

Total Sample Size="60"
Sample Size from India="60"
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

Date of First Enrollment (India)

09/05/2024

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="1"
Months="6"
Days="20"

Recruitment Status of Trial (Global)
Modification(s)

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

Case history shall be recorded and clinical and radiographic examination will be performed to confirm symptomatic irreversible pulpitis . Vitality of tooth will be confirmed by EPT. Patients will be randomly allocated to two groups:

Group 1: Control

Group 2: Experimental

In group 1, 2% lignocaine anesthetic gel will be applied and after 1min, local anesthesia at room temperature will be administered via buccal infiltration.

In group 2, precooling of the injection site shall be done with ice stick for 10 sec followed by 1.8ml of cold local anesthesia (6-10â„ƒ) administration.

Patients would be directed to rate the pain following administration of local anesthesia using HP-VAS which would be recorded as pain on injection. EPT will be applied every 1min, until a negative response is obtained. This duration will be taken as the time of onset.

Endodontic treatment will be initiated . Patients would be directed to rate any pain during access preparation, pulp extirpation and instrumentation. Anesthesia shall be considered to be successful if there is no pain or only mild pain during endodontic procedure according to HP-VAS scale.