CTRI Number |
CTRI/2022/06/043611 [Registered on: 30/06/2022] Trial Registered Prospectively |
Last Modified On: |
01/07/2022 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Dentistry |
Study Design |
Randomized, Parallel Group Trial |
Public Title of Study
Modification(s)
|
To Compare 2LA in dentistry |
Scientific Title of Study
|
Anesthetic efficacy of 4 % Articaine buccal infiltration versus 2% lignocaine inferior alveolar nerve block in lower primary molars indicated for endodontic treatment. |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Snigdha Trivedi |
Designation |
PG student |
Affiliation |
SGT University |
Address |
Room No-6,Department of Pediatric and Preventive dentistry, Faculty of Dental Sciences, Gurgaon
Gurgaon HARYANA 122505 India |
Phone |
9811105319 |
Fax |
|
Email |
trivedi.snigdha0110@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr Ankit Srivastav |
Designation |
Professor |
Affiliation |
SGT University |
Address |
Room No-6,Department of Pediatric and Preventive dentistry, Faculty of Dental Sciences, Gurgaon
Gurgaon HARYANA 122505 India |
Phone |
8130023844 |
Fax |
|
Email |
ankit.srivastav@sgtuniversity.org |
|
Details of Contact Person Public Query
|
Name |
Snigdha Trivedi |
Designation |
PG student |
Affiliation |
SGT University |
Address |
Room No-6,Department of Pediatric and Preventive dentistry, Faculty of Dental Sciences, Gurgaon
Gurgaon HARYANA 122505 India |
Phone |
9811105319 |
Fax |
|
Email |
trivedi.snigdha0110@gmail.com |
|
Source of Monetary or Material Support
|
SGT University, Budhera, Gurgaon,122505 |
|
Primary Sponsor
|
Name |
SGT University |
Address |
Faculty of Dental Sciences, SGT University,Gurgaon-122505 |
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 |
Snigdha Trivedi |
SGT University |
Room No-6.Department of Pediatric and Preventive Dentistry, Faculty of Dental Sciences Gurgaon HARYANA |
9811105319
trivedi.snigdha0110@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
SRI GURUGOBIND SINGH TRICENTENARY UNIVERSITY,GURGAON |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition: K029||Dental caries, unspecified, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Comparator Agent |
2 % Lignocaine Inferior alveolar Nerve block injection for endodontic treatment of lower primary molars |
1.8 ml Lignocaine with 1:80,000 adrenaline via Inferior Alveolar Nerve Block with a standard aspirating syringe with 26-gauge 1.5-inch needle single injection just before the procedure |
Intervention |
4 % Articaine buccal infiltration injection for endodontic treatment of lower primary molars |
1.8ml of 4% articaine with 1:100,000 adrenaline as Buccal infiltration with a standard aspirating syringe and 26-gauge 0.5-inch needle single injection just before the procedure |
|
Inclusion Criteria
|
Age From |
4.00 Year(s) |
Age To |
8.00 Year(s) |
Gender |
Both |
Details |
1.Children of age 4-8 years
2.Indicated for pulpotomy/pulpectomy in mandibular primary molars
|
|
ExclusionCriteria |
Details |
1.Medically compromised patient
2.Any known allergy to local anesthetic agents
|
|
Method of Generating Random Sequence
|
Other |
Method of Concealment
|
Other |
Blinding/Masking
|
Not Applicable |
Primary Outcome
|
Outcome |
TimePoints |
To evaluate and compare the anaesthetic efficacy of 4 % articaine buccal infiltration versus 2% lignocaine inferior alveolar nerve block in lower primary molars indicated for endodontic treatment |
Clinical evaluation at baseline,4 weeks |
|
Secondary Outcome
|
Outcome |
TimePoints |
• To evaluate pain and discomfort of the patient during anaesthesia with 4% articaine buccal infiltration and 2% lidocaine inferior alveolar nerve block |
Clinical Evaluation at baseline,4 weeks |
|
Target Sample Size
|
Total Sample Size="44" Sample Size from India="44"
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
|
N/A |
Date of First Enrollment (India)
|
01/07/2022 |
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="0" Days="0" |
Recruitment Status of Trial (Global)
|
Not Applicable |
Recruitment Status of Trial (India) |
Not Yet Recruiting |
Publication Details
|
nil |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
|
Successful anaesthesia
is the hallmark of painless endodontic treatment. Pulpal anaesthesia commences with the administration of traditional
nerve blocks or infiltration anaesthesia. Conventionally
it was thought that the Inferior alveolar nerve bock (IANB) is the local anaesthesia
technique of choice over when treating mandibular primary or permanent molars for endodontic treatment. The primary advantage of this block is the
depth of anaesthesia6. All the molars, canines and incisors on the
injected side are anesthetized and hence allows for treatment of multiple teeth of the same quadrant at one appointment
. 2 % lignocaine is considered
as the gold standard among local anaesthetic agents
Unfortunately,
IANB is associated with several complications such as transient facial
paralysis, trismus, local anaesthetic getting injected into the blood vessel
and prolonged soft tissue anaesthesia which results in self-inflicted trauma
such as biting of lip and cheek specially in paediatric population. Buccal
infiltration (BI) has been suggested as a simpler modality than IANB and is
being widely advocated in recent studies. Due to low
penetration of lidocaine through the buccal cortical plate, BI using lidocaine
is not as effective as IANB for achieving profound anaesthesia in mandibular
primary molars. 4
percent Articaine for BI in mandibular primary molar, has increased lipid solubility and high tissue permeability
enables it to diffuse through the mandibular dense cortical bone as well as
maxillary cortical plates (11)
Hence the
present study aims to compare the anaesthetic efficacy of 4 % articaine
buccal infiltration versus 2% lignocaine inferior alveolar nerve block in lower
primary molars indicated for endodontic treatment
|