| CTRI Number |
CTRI/2024/05/067798 [Registered on: 22/05/2024] Trial Registered Prospectively |
| Last Modified On: |
09/07/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A clinical study to evaluate the anesthetic efficacy of two types of local anesthetic agents during root canal treatment of symptomatic tooth |
|
Scientific Title of Study
|
Comparison of anesthetic efficacy of 4 percent articaine with epinephrine in the ratio of 1 to 100000 as buccal infiltration and 2 percent lignocaine with epinephrine in the ratio of 1 to 80000 as inferior alveolar nerve block in patients with irreversible pulpitis A randomized 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 |
ABHIJIT GHOSH |
| Designation |
MDS Post Graduate Trainee |
| Affiliation |
Guru Nanak Institute of Dental Sciences and Research |
| Address |
Guru Nanak Institute of Dental Sciences and Research
157/F Nilgunj Road Panihati Sodepur Kolkata.
Department of Conservative Dentistry and Endodontics, Room number 2, Second floor.
Kolkata
WEST BENGAL
700114
India |
| Phone |
09062631801 |
| Fax |
|
| Email |
draghosh99@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Paromita Mazumdar |
| Designation |
Professor and Head of the Department |
| Affiliation |
Guru Nanak Institute of Dental Sciences and Research |
| Address |
Guru Nanak Institute of Dental Sciences and Research
157/F Nilgunj Road Panihati Sodepur Kolkata.
Department of Conservative Dentistry and Endodontics, Room number 2, Second floor.
Kolkata
WEST BENGAL
700114
India |
| Phone |
9831029606 |
| Fax |
|
| Email |
head_cons.gnidsr@jisgroup.org |
|
Details of Contact Person
Public Query
|
| Name |
ABHIJIT GHOSH |
| Designation |
MDS Post Graduate Trainee |
| Affiliation |
Guru Nanak Institute of Dental Sciences and Research |
| Address |
Guru Nanak Institute of Dental Sciences and Research
157/F Nilgunj Road Panihati Sodepur Kolkata.
Department of Conservative Dentistry and Endodontics, Room number 2, Second floor.
Kolkata
WEST BENGAL
700114
India |
| Phone |
09062631801 |
| Fax |
|
| Email |
draghosh99@gmail.com |
|
|
Source of Monetary or Material Support
|
| Guru Nanak Institute of Dental Sciences and Research, 157/F, Nilgunj Road, Sahid Colony,
Panihati, Kolkata- 700114 |
|
|
Primary Sponsor
|
| Name |
Guru Nanak Institute of Dental Sciences and Research |
| Address |
Guru Nanak Institute of Dental Sciences and Research
157/F, Nilgunj Road, Panihati, Sodepur, Kolkata-700114, West Bengal , India |
| 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 |
| DR ABHIJIT GHOSH |
Guru Nanak Institute of Dental Sciences & Research |
157/F Nilgunj Road Sahid Colony Panihati Kolkata 700114
Department of Conservative Dentistry and Endodontics Second floor
Kolkata
WEST BENGAL |
09062631801
draghosh99@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K039||Disease of hard tissues of teeth,unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
1.Articaine
2.Lignocaine |
1.4% Articaine With 1:100,000 epinephrine
2.2% Lignocaine WITH 1:80,000 epinephrine
Route of administration:-
1.Buccal infiltration (4% articaine with 1:100000 epinephrine)
2.Inferior alveloar nerve block(2% Lignocaine with 1:80000 epinephrine) |
| Comparator Agent |
1.Articaine
2.Lignocaine |
1.4% Articaine With 1:100,000 epinephrine
2.2% Lignocaine WITH 1:80,000 epinephrine
Route of administration:-
1.Buccal infiltration (4% articaine with 1:100000 epinephrine)
2.Inferior alveloar nerve block(2% Lignocaine with 1:80000 epinephrine) |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients with irreversible pulpitis
2.Permanent mandibular 1st molar
3.Tooth with closed apex
4.Teeth with sound periodontal
apparatus
5.Only healthy individual(ASA I or II)
|
|
| ExclusionCriteria |
| Details |
1.Patients allergic to amide local anesthetics
2.Non vital teeth
3.Patients taking antibiotics and/or analgesic in last 5 days
4.Retreatment cases
5.Teeth with calcified canals
Pregnant and lactating women.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.To compare the onset of anesthesia using 4% articaine with 1:100,000 epinephrine as buccal infiltration & 2% Lignocaine with 1:80,000 epinephrine as inferior alveolar nerve block.
2. To compare the duration of anesthesia using 4% articaine with 1:100,000 epinephrine as buccal infiltration & 2% Lignocaine with 1:80,000 epinephrine as inferior alveolar nerve block
3. To compare the effectiveness of anesthesia (pain assessment) using Heft Parker scale using 4% articaine with 1:100,000 epinephrine & 2% Lignocaine with 1:80,000 as inferior alveolar nerve block
|
1.Onset of anesthesia:-Time lapse between the end of the anesthesia given and onset of symptoms of subjective anesthesia
2.Duration of anesthesia:It will be calculated by recording the time of onset of anesthesia and patient reporting the loss of numbness by thorough conversation with patient over telephone 1hr ,2hr,3 hr,4 hr immediately after obturation
3.Pain asessment :Pre-operative,During the operative procedure and 6 & 12 hr after completion of the endodontic procedure |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Retrospective analysis of CBCT Scan to determine cause-effect relationship of the clinical outcome[Bone width,position of the apical foramen]
|
7 days after completion of the endodontic procedure |
|
|
Target Sample Size
|
Total Sample Size="22"
Sample Size from India="22"
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)
|
01/06/2024 |
| 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="0"
Months="3"
Days="1" |
Recruitment Status of Trial (Global)
Modification(s)
|
Open to Recruitment |
| 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
|
AIM OF THE STUDY: To compare onset,duration and anesthetic efficacy of 4% Articaine with 1:100,000 epinephrine buccal infiltration and 2% lignocaine with 1:80,000 epinephrine inferior alveolar nerve block in patients with irreversible pulpitis
MATERIALS AND METHODS: The study is designed as a prospective, randomized, double blinded, clinical trial. 22 patients will be enrolled from the Department of Conservative Dentistry and Endodontics who are systemically healthy[ASA I & II) between 18-45 years of age and fulfilling the inclusion criteria of the study. Patient will be randomly assigned into two equal groups using Simple Random Sampling sequentially.Odd number will be assigned to Group 1 (1,3,5) and even number will be assigned to Group 2 (2,4,6).
Group I (n=11)Buccal infiltration using standard cartridges of 4 % articaine with 1:100000 epinephrine Group II(n=11) Inferior alveolar nerve block using standardized cartridges of 2% lignocaine with 1:80000 epinephrine
Patient and outcome assessor will be blinded to the groups of the study. The randomized order of instrumentation procedure will be enclosed in sealed, opaque envelopes. Treatment will be carried out in single visit. Root canal treatment will be performed after administration of these two type of anesthetic agents and mode of administration. Each of the 22 patients, will be taught how to use Heft Parker Pain assessment scale. . Pain will be evaluated at following time intervals: Just before administration of anesthetic agents,during the endodontic procedure,immediate after obturation and 6 & 12 hr after completion of the procedure.Onset and duration of two types of anesthetic agents will be evaluated with the help of a digital stop watch. |