CTRI Number |
CTRI/2023/07/055648 [Registered on: 25/07/2023] Trial Registered Prospectively |
Last Modified On: |
23/07/2023 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Dentistry |
Study Design |
Randomized, Parallel Group, Active Controlled Trial |
Public Title of Study
|
Effect of cooled injection on injection pain and effectiveness for root canal treatment of painful lower back teeth |
Scientific Title of Study
|
Effect of precooling injection site and cold anesthetic administration on injection pain and anesthetic efficacy of inferior alveolar nerve block(IANB) in mandibular molars with symptomatic irreversible pulpitis - A randomised 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 |
Sumaya changaranchola |
Designation |
Junior resident ,Department of Conservative Dentistry and Endodontics |
Affiliation |
Government Dental College Kottayam |
Address |
Department of Conservative Dentistry and Endodontics, Government Dental College Kottayam.
Kottayam KERALA 686008 India |
Phone |
9995965474 |
Fax |
|
Email |
sumayacc@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
DrSheena P |
Designation |
Associate Professor ,Department of Conservative Dentistry and Endodontics |
Affiliation |
Government Dental College Kottayam |
Address |
Department of Conservative Dentistry and Endodontics ,Government Dental College Kottayam
Kottayam KERALA 686008 India |
Phone |
9847632380 |
Fax |
|
Email |
sheenababu.p@gmail.com |
|
Details of Contact Person Public Query
|
Name |
DrSheena P |
Designation |
Associate Professor ,Department of Conservative Dentistry and Endodontics |
Affiliation |
Government Dental College Kottayam |
Address |
Department of Conservative Dentistry and Endodontics ,Government Dental College Kottayam
Kottayam KERALA 686008 India |
Phone |
9847632380 |
Fax |
|
Email |
sheenababu.p@gmail.com |
|
Source of Monetary or Material Support
|
Government Dental College Gandhinagar PO Kottayam Kerala Pin code 686008 |
|
Primary Sponsor
|
Name |
Sumaya Changaranchola |
Address |
Junior resident Department of Conservative Dentistry and Endodontics Government Dental College Kottayam |
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 sumaya changaranchola |
Government dental college kottayam |
Room number 404
Conservative Dentistry and Endodontics
Government dental college kottayam Gandhinagar PO Kottayam KERALA |
9995965474
sumayacc@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Institutional ethics committee(IEC)/Institutional Review Board(IRB) Government Dental College Kottayam |
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 |
Comparator Agent |
Group I: lignocaine with epinephrine at room temperature (control) |
Administering local anesthesia(lignocaine 2% with epinephrine 1:200000) at room temperature for inferior alveolar nerve block for root canal treatment of mandibular molars and assessment of pain on injection, onset of action of anesthesia and duration of action of anesthesia. Duration of intervention - one to two hours |
Intervention |
Group II: lignocaine with epinephrine refrigerated (4-6degree Celsius) |
Administering local anesthesia (lignocaine 2% with epinephrine 1:200000) refrigerated at 4-6degree Celsius for inferior alveolar nerve block for root canal treatment of mandibular molars and assessment of pain on injection ,onset of action of anesthesia and duration of action of anesthesia .intervention period is one to two hours |
Intervention |
Group III: lignocaine with epinephrine refrigerated, topical ice application for 15 seconds at injection site. |
Administering local anesthesia ((lignocaine 2% with epinephrine 1:200000 refrigerated at 4 to 6 degree Celsius and topical ice application for 15 seconds at injection site for inferior alveolar nerve block for root canal treatment of mandibular molars and assessment of pain on injection ,onset of action of anesthesia and duration of action of anesthesia. intervention period is one to two hours |
|
Inclusion Criteria
|
Age From |
18.00 Year(s) |
Age To |
50.00 Year(s) |
Gender |
Both |
Details |
Healthy adult patients aged 18 to 50 years
Presence of irreversible pulpitis in a mandibular first molar, without any signs of periapical involvement.
Presence of healthy adjacent and contra-lateral second premolars |
|
ExclusionCriteria |
Details |
Patients with known allergy, sensitivity or contraindication to lignocaine
Presence of systemic or mental disorders, pregnancy, lactation
Patients who had taken analgesics within 12 hours before root canal therapy
Presence of non-vital pulp tissue on access opening
Molars with calcified canals, pulp stones |
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
Method of Concealment
|
Pre-numbered or coded identical Containers |
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
Primary Outcome
|
Outcome |
TimePoints |
pain on injection
|
At baseline |
|
Secondary Outcome
|
Outcome |
TimePoints |
Duration of Anesthesia |
At baseline
From onset of anesthesia (2 to 3 minutes after injection )
till wearing off anesthesia |
onset of anesthesia |
At baseline
Time from administration of anesthesia to onset of action of anesthesia |
|
Target Sample Size
|
Total Sample Size="45" Sample Size from India="45"
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 4 |
Date of First Enrollment (India)
|
01/08/2023 |
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="1" 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
|
An important requirement prior to initiating endodontic or operative dental treatment is the ability to achieve and maintain profound anesthesia. Local anesthetic solutions have been utilized in clinical dentistry to alleviate or eliminate pain associated with invasive procedures as early as the 19th century. An inferior alveolar nerve block (IANB)is the standardized injection technique for mandibular molar teeth. However, IANB does not always result in successful pulpal anesthesia, especially in patients with symptomatic irreversible pulpitis. The fact that patients often feel pain during endodontic treatment of teeth with symptomatic irreversible pulpitis is a challenge for the clinician. Successful anesthesia is only achieved if no or minimal pain is achieved during access cavity preparation and canal shaping. Various different approaches have been tested to improve the success rate of IANBs in mandibular molars with symptomatic irreversible pulpitis. These include different anesthetic techniques for IANB, different anesthetic solutions, supplemental infiltration techniques, acupuncture, and premedication before the IANB is performed. Despite these approaches, the success rate of IANBs in mandibular molars with symptomatic irreversible pulpitis ranges from 15 -57 %. It is a well-established physiological phenomenon that heat has the property of vasodilatation and cold has the property of vasoconstriction. Cold also has analgesic and anesthetic effects. In medicine, the application of a frozen gel pack for 5 min prior to Botulinum toxin A injection resulted in a statistically significant pain reduction. In the field of neuroscience, cooling of lignocaine was also found to have beneficial effects like faster onset of action and prolonged duration of action. Dabarakis et al showed that mepivacaine at a temperature of 4°C had a longer duration of pulpal anesthesia for the maxillary first premolar than at room temperature. Some studies have been performed to evaluate the effect of cryotherapy and cooling of lignocaine on the injection pain and efficacy of maxillary infiltration and studies on cooled lignocaine injection of IANB. It is not known whether cooling of lignocaine hydrochloride and precooling injection site will have any beneficial effect, when used for inferior alveolar nerve block (IANB). Hence, the purpose of this study was to evaluate the effects of cooling 2% lignocaine hydrochloride with 1:2,00,000 epinephrine along with precooling injection site on the primary outcomes of onset and duration of IANB. The secondary outcome to assess is pain on injection. |