CTRI Number |
CTRI/2018/03/012834 [Registered on: 26/03/2018] Trial Registered Prospectively |
Last Modified On: |
02/07/2022 |
Post Graduate Thesis |
No |
Type of Trial |
Interventional |
Type of Study
|
Surgical/Anesthesia Dentistry |
Study Design |
Randomized, Parallel Group Trial |
Public Title of Study
|
Assessing the effectiveness of cold local anesthesia in management of acute tooth pain |
Scientific Title of Study
|
Evaluation of pain on injection, onset and anesthetic efficacy of precooled injection site and 2% lignocaine (4-6ºC) during maxillary infiltration in patients with symptomatic irreversible pulpitis - a randomized controlled trial |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Ishwarya Gurucharan |
Designation |
Post graduate student |
Affiliation |
SRM Dental College, Ramapuram |
Address |
Main block, 2nd floor, Department of conservative dentistry and endodontics,
SRM dental college, Ramapuram, Bharathi Salai, Chennai. Main block, 2nd floor, Department of conservative dentistry and endodontics,
SRM dental college, Ramapuram, Bharathi Salai, Chennai. Chennai TAMIL NADU 600089 India |
Phone |
9840377323 |
Fax |
04422490009 |
Email |
sriish@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Sekar Mahalaxmi |
Designation |
MDS, Professor and Head |
Affiliation |
SRM Dental College, Ramapuram |
Address |
Main block, 2nd floor, Department of conservative dentistry and endodontics,
SRM dental college, Ramapuram, Bharathi Salai, Chennai. Main block, 2nd floor, Department of conservative dentistry and endodontics,
SRM dental college, Ramapuram, Bharathi Salai, Chennai. Chennai TAMIL NADU 600089 India |
Phone |
9381018598 |
Fax |
04422490009 |
Email |
researchmaha@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Sekar Mahalaxmi |
Designation |
MDS, Professor and Head |
Affiliation |
SRM Dental College, Ramapuram |
Address |
Main block, 2nd floor, Department of conservative dentistry and endodontics,
SRM dental college, Ramapuram, Bharathi Salai, Chennai. Main block, 2nd floor, Department of conservative dentistry and endodontics,
SRM dental college, Ramapuram, Bharathi Salai, Chennai. Chennai TAMIL NADU 600089 India |
Phone |
9381018598 |
Fax |
04422490009 |
Email |
researchmaha@gmail.com |
|
Source of Monetary or Material Support
|
|
Primary Sponsor
|
Name |
Ishwarya Gurucharan |
Address |
SRM Dental College, Barathi Salai, Ramapuram, Chennai |
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 |
Ishwarya Gurucharan |
SRM dental college |
Main block, second floor, Department of conservative dentistry and endodontics, Bharathi Salai, Ramapuram, Chennai Chennai TAMIL NADU |
9840377323
sriish@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Institutional Review Board, SRM dental College, Ramapuram |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
Health Type |
Condition |
Healthy Human Volunteers |
ASA Category 1 |
Patients |
Symptomatic irreversible pulpitis,
Hot tooth, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Intervention |
8-10 degrees celcius cold lignocaine
|
Ice sticks will be used for surface anesthesia |
Comparator Agent |
Room temperature lignocaine |
Topical local anesthesia gel will be used for surface anesthesia |
|
Inclusion Criteria
|
Age From |
18.00 Year(s) |
Age To |
45.00 Year(s) |
Gender |
Both |
Details |
Healthy adult patients aged 18 to 45 years who are willing to give informed consent
Teeth with acute and spontaneous pain
Patients with symptomatic irreversible pulpitis in maxillary molars of both the quadrants
Presence of vital tissue on access opening |
|
ExclusionCriteria |
Details |
Allergic to Local anesthetics
Medically compromised patients (ASA Class III or higher)
Patients under medication which may affect the pain assessment
Inability to give informed consent
Teeth with
presence of Periapical radiolucencies
presence of active pathosis in the injection site
vertical fractures
periodontally compromised teeth
nonrestorable teeth |
|
Method of Generating Random Sequence
|
Computer generated randomization |
Method of Concealment
|
On-site computer system |
Blinding/Masking
|
Outcome Assessor Blinded |
Primary Outcome
|
Outcome |
TimePoints |
Reduced pain on injection
Faster onset of pulpal anesthesia |
Onset - 1 minute after injection of anesthesia |
|
Secondary Outcome
|
Outcome |
TimePoints |
Greater anesthetic efficacy |
15 minutes |
|
Target Sample Size
|
Total Sample Size="60" Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "16"
Final Enrollment numbers achieved (India)="16" |
Phase of Trial
|
Phase 2/ Phase 3 |
Date of First Enrollment (India)
|
02/04/2018 |
Date of Study Completion (India) |
15/02/2019 |
Date of First Enrollment (Global) |
Date Missing |
Date of Study Completion (Global) |
Date Missing |
Estimated Duration of Trial
|
Years="0" Months="6" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
published |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
|
Achieving profound pulpal anesthesia in endodontics is a challenging task, particularly, in cases of acutely inflamed teeth. When conventional primary anesthetic techniques fail, there might be a need for a supplemental anesthesia. Local anesthetic(LA) administration may also add to patient’s discomfort. Cold application to a localized area to block the pain impulses is referred to as “Cryoanesthesiaâ€, which is widely practiced in the field of medicine. One of the strategies to reduce pain perception during local anesthetic administration is precooling the injection site, as stated by Ghaderi et al.(2013) Further, use of cooled anesthetic solution to enhance pulpal anesthesia is attributed to an increase in affinity of the charged anesthetic molecule to nerve receptors. However, the effect of refrigerated 2% lignocaine HCl for maxillary infiltration anesthesia in molars has not been evaluated yet. Hence, the aim of the present study is to assess the effects of precooling the injection site and administration of cold 2% lignocaine HCl (8-10oC) in symptomatic irreversible pulpitis of maxillary molars and also to compare the pain on injection, onset of action and anesthetic efficacy achieved with that of 2% lignocaine HCl (room temperature), with and without precooling the injection site. The experimental groups are: Group 1: Precooling the injection site and cold 2% lignocaine HCl. Group 2: LA gel with 2% lignocaine HCl (room temperature) Pain score will be assessed using Heft Parker scale (VAS) and other parameters will be assessed using EPT. |