| CTRI Number |
CTRI/2021/09/036955 [Registered on: 29/09/2021] Trial Registered Prospectively |
| Last Modified On: |
22/04/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
a study to compare the two techniques of anesthesia in patients with pain in lower teeth |
|
Scientific Title of Study
|
Comparative Evaluation of Inferior Alveolar and Gow Gates Nerve Block Techniques 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 |
Hemant Arora |
| Designation |
pg student |
| Affiliation |
jn kapoor dav dental college, yamunanagar |
| Address |
department of conservative dentistry and endodontics, room no. 3, J.N. Kapoor D.A.V. dental college
Yamunanagar
HARYANA
135001
India |
| Phone |
|
| Fax |
|
| Email |
hemantarora.ha@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
poonam bogra |
| Designation |
professor and head |
| Affiliation |
jn kapoor dav dental college, yamunanagar |
| Address |
department of conservative dentistry and endodontics, room no. 3, J.N. Kapoor D.A.V. dental college
Yamunanagar
HARYANA
135001
India |
| Phone |
09050462962 |
| Fax |
|
| Email |
poonambogra@yahoo.in |
|
Details of Contact Person
Public Query
|
| Name |
hemant arora |
| Designation |
pg student |
| Affiliation |
jn kapoor dav dental college, yamunanagar |
| Address |
department of conservative dentistry and endodontics, room no. 3, J.N. Kapoor D.A.V. dental college
Yamunanagar
HARYANA
135001
India |
| Phone |
7027262626 |
| Fax |
|
| Email |
poonambogra@yahoo.in |
|
|
Source of Monetary or Material Support
|
| jn kapoor dav dental college |
|
|
Primary Sponsor
|
| Name |
jn kapoor dav dental college |
| Address |
J.N. Kapoor D.A.V. dental college, Yamunanagar |
| Type of Sponsor |
Private 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 |
| Hemant Arora |
J.N. Kapoor D.A.V. dental college |
depatment of coservative dentistry and endodontics, room no. 3, J.N. Kapoor D.A.V. dental college, yamunanagar
Yamunanagar
HARYANA |
7027262626
hemantarora.ha@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| institutional |
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 |
| Intervention |
gow gates mandibular nerve block using 2% lidocaine |
gow gates mandibular nerve block will be administered in patients with symptomatic irreversible pulpitis in mandibular molars using 2% lidocaine |
| Intervention |
gow gates mandibular nerve block using 4% articaine |
gow gates mandibular nerve block will be administered in patients with symptomatic irreversible pulpitis in mandibular molars using 4% articaine |
| Intervention |
inferior alveolar nerve block using 2% lidocaine |
inferior alveolar nerve block will be administered in patients with symptomatic irreversible pulpitis in mandibular molars using 2% lidocaine |
| Intervention |
inferior alveolar nerve block using 4% articaine |
inferior alveolar nerve block will be administered in patients with symptomatic irreversible pulpitis in mandibular molars using 4% articaine |
| Comparator Agent |
not applicable |
not applicable |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
1. patients with mandibular molars diagnosed with symptomatic irreversible pulpitis
2. healthy patients without any significant medical disorders
3. patients with preoperative pain more than 54 mm on a heft parker visual analog scale 0-170mm |
|
| ExclusionCriteria |
| Details |
1. patients allergic or hypertensive to articaine or lignocaine
2. patients with any systemic diseases, mental disorder, pregnancy or lactation
3. patients with any facial paresthesia or any pathosis on the site of injection
4. patients with pathologic periodontal pocket during probing
5. teeth with fused roots or radiographic evidence of extra root
6. patients taking any medication that interferes with anesthesia like beta blockers or antidepressants
7. mandibular molars showing no response to cold test, exhibiting periradicular pathosis, internal and external root resorption or with non vital pulp at access opening
8 patient who is alcoholic |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.to test the efficacy of anesthesia after 15 minutes of injection using cold test and electronic pulp tester
2. efficacy of pulpal anesthesia during root canal treatment on heft parker vas |
1.to test the efficacy of anesthesia after 15 minutes of injection using cold test and electronic pulp tester
2. efficacy of pulpal anesthesia during root canal treatment on heft parker vas |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| pain during cleaning and shaping of root canals, to be recorded on heft parker VAS |
at baseline |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
Final Enrollment numbers achieved (Total)= "120"
Final Enrollment numbers achieved (India)="120" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
10/10/2021 |
| Date of Study Completion (India) |
31/03/2022 |
| Date of First Enrollment (Global) |
10/10/2021 |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study is a randomized controlled clinical trial which will evaluate effect of anesthesia with inferior alveolar and Gow Gate’s mandibular nerve block techniques using 4% Articaine and 2% Lignocaine. my study period will be 1 year. Mandibular molars with symptomatic irreversible pulpitis indicated for root canal treatment will be selected from the regular pool of patients coming to the Department of Conservative dentistry and Endodontics at J.N. Kapoor D.A.V (C) Dental College, Yamunanagar. A sample size of 120 teeth will be taken which will be divided equally (60 teeth each) in Group I and II. Teeth in Group I will be injected using inferior alveolar nerve block and teeth in Group II will be injected using Gow Gate’s mandibular nerve block. Group I and II will be subdivided into subgroups I a, I b and II a, II b respectively. Subgroup I a will be injected with 4% Articaine and I b will be injected with 2% Lidocaine. Subgroups II a and II b will be injected with 4% Articaine and 2% Lidocaine respectively. |