| CTRI Number |
CTRI/2019/04/018643 [Registered on: 18/04/2019] Trial Registered Prospectively |
| Last Modified On: |
18/07/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of different anesthetic injections on success rate of the injections while managing a painful tooth |
|
Scientific Title of Study
|
Effect of varying concentrations of epinephrine in 2% lidocaine on the anesthetic success rate of intraligamentary injections in patients with symptomatic irreversible pulpitis |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Vivek Aggarwal |
| Designation |
Associate Professor |
| Affiliation |
Jamia Millia Islamia |
| Address |
Room 311, Department of Conservative Dentistry and Endodontics
Faculty of Dentistry, JMI
South
DELHI
110025
India |
| Phone |
9818188358 |
| Fax |
|
| Email |
drvivekaggarwal@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Vivek Aggarwal |
| Designation |
Associate Professor |
| Affiliation |
Jamia Millia Islamia |
| Address |
Room 311, Department of Conservative Dentistry and Endodontics
Faculty of Dentistry, JMI
DELHI
110025
India |
| Phone |
9818188358 |
| Fax |
|
| Email |
drvivekaggarwal@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Vivek Aggarwal |
| Designation |
Associate Professor |
| Affiliation |
Jamia Millia Islamia |
| Address |
Room 311, Department of Conservative Dentistry and Endodontics
Faculty of Dentistry, JMI
DELHI
110025
India |
| Phone |
9818188358 |
| Fax |
|
| Email |
drvivekaggarwal@gmail.com |
|
|
Source of Monetary or Material Support
|
| Faculty of Dentistry, JMI |
|
|
Primary Sponsor
|
| Name |
Faculty of Dentistry self funded |
| Address |
Faculty of Dentistry, Jamia Millia Islamia, new delhi |
| Type of Sponsor |
Government medical college |
|
|
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 Vivek Aggarwal |
Faculty of Dentistry, JMI |
Room 311, Department of Conservative Dentistry and Endodontics
Faculty of Dentistry, JMI
South
DELHI |
09818188358
drvivekaggarwal@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Research review Comittee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Painful Symptomatic carious exposed mandibular first or second molars |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
supplementary intraligamentary injections of 2% lidocaine with 1:200 000 epinephrine |
All patients will receive a primary inferior alveolar nerve block injection using 1.8 mL of 2% lidocaine with 1: 80 000 epinephrine using a direct Halsted approach. In case of pain during treatment, the patients will receive supplementary intraligamentary injections.
The injections will be administered using a pressure type syringe and 30 gauge short needles, at the mesial and distal line angles of the gingival sulcus. |
| Intervention |
supplementary intraligamentary injections of 2% lidocaine with 1:80 000 epinephrine |
All patients will receive a primary inferior alveolar nerve block injection using 1.8 mL of 2% lidocaine with 1: 80 000 epinephrine using a direct Halsted approach. In case of pain during treatment, the patients will receive supplementary intraligamentary injections.
The injections will be administered using a pressure type syringe and 30 gauge short needles, at the mesial and distal line angles of the gingival sulcus. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
a. Symptomatic carious exposed mandibular first or second molars.
b. Positive and prolonged response to thermal sensitivity tests and electric pulp test.
c. Vital coronal pulp on access cavity preparation.
d. American Society of Anesthesiologists class I or II medical history.
e. Ability to understand the use of pain scales.
|
|
| ExclusionCriteria |
| Details |
a. Active pain in more than 1 teeth.
b. Teeth with fused roots.
c. Radiographic evidence of an extra root.
d. Large restorations with overhanging margins.
e. Full crowns or deep periodontal pockets.
f. Known allergy or contraindications to any content of the local anesthetic solution.
g. History of known or suspected drug abuse.
h. Taking any drugs which could affect the pain perception, e.g, opiods, antidepressants, anticonvulsants, muscle relaxants, anxiolytics, sedatives, nsaids. 23
i. Pregnant or breastfeeding patients.
|
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The primary outcome (endpoint) will be defined as “success or failure†which will be indicated as the ability to undertake pulp access and canal instrumentation with no or mild pain. |
The primary outcome (endpoint) will be defined as “success or failure†which will be indicated as the ability to undertake pulp access and canal instrumentation with no or mild pain. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The secondary outcome will be the evaluation of heart rate. |
Immediately after supplementary intraligamentary injections. |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="100" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
22/04/2019 |
| Date of Study Completion (India) |
01/09/2019 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="2"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
The study shall be submitted for publication in a suitable speciality journal. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Introduction: To achieve painless treatment in patients with a failed primary
IANB, supplementary anesthesia has been advised. Majority of the studies
evaluating intraligamentary injections have been performed on asymptomatic
teeth. Very limited research has been dedicated to the evaluation of different
variables in intraligamentary injections in patients with symptomatic
irreversible pulpitis Aim: To evaluate the anesthetic efficacy of 2% lidocaine
with 1:80 000 epinephrine vs. 2% lidocaine with 1:200 000, given as
intraligamentary injections after a failed inferior alveolar nerve block (IANB)
,in patients with symptomatic irreversible pulpitis. Objective : 1.To achieve
painless treatment in patients with a failed primary IANB. during the
endodontic management of symptomatic mandibular first/second molar. 2. To evaluate the heart rate during and after intraligamentary
injections
Methods: This prospective, randomized, double-blind clinical trial will be carried
out Conservative Dentistry, Faculty Of Dentistry, Jamia Millia Islamia. Sixty
adult patients with symptomatic irreversible pulpits in a mandibular first or
second molar, will receive an initial
IANB with 2% lidocaine with 1:80 000 epinephrine. Pain during the endodontic
treatment will be assessed using a visual analogue scale(VAS). Patients
experiencing pain on endodontic intervention shall be randomly allocated to one
of the two treatment groups: one group shall receive 0.6 mL/ root of
supplementary intraligamentary injection of 2% lidocaine with 1:80 000
epinephrine; while the second group shall receive 2% lidocaine with 1:200 000
epinephrine. Endodontic treatment will be re-initiated. Success after primary
injection or supplementary injection will be defined as no or mild pain (less
than 55 mm on HP VAS) during access preparation and root canal instrumentation.
Heart rate will be monitored using a finger pulse oximeter by faculty member . Statistical analysis : The results will
be tabulated in contingency tables. The anesthetic success rates will be
analyzed with Pearson chi-square test at 5% significance levels. The heart rate
changes will be analyzed using t-test. |