| CTRI Number |
CTRI/2025/01/079394 [Registered on: 24/01/2025] Trial Registered Prospectively |
| Last Modified On: |
24/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparative Evaluation of anesthetic efficacy of buccal infiltration combined with lingual infiltration with Articaine Vs Buccal infiltration combined with IAN Block with Lignocaine in mandibular molars with symptomatic irreversible pulpitis: A Double Blinded, Randomized clinical trail. |
|
Scientific Title of Study
|
Comparative Evaluation of anesthetic efficacy of buccal infiltration combined with lingual infiltration with Articaine Vs Buccal infiltration combined with Inferior Alveolar Nerve Block with Lignocaine in mandibular molars with symptomatic irreversible pulpitis: A Double Blinded, Randomized clinical trail. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Mallika Rawat |
| Designation |
Post Graduate student |
| Affiliation |
SGT Sental College and Hospital, SGT University |
| Address |
Department of Conservative dentistry and Endodontics, Room no 204, SGT Dental College and Hospital, Gurugram
Gurgaon
HARYANA
122002
India |
| Phone |
09871213320 |
| Fax |
|
| Email |
rawatmallika98@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sumeet Sharma |
| Designation |
Head of Department, Dept. of Conservative dentistry and Endodontics |
| Affiliation |
SGT Dental College and Hospital, SGT University |
| Address |
Department of conservative dentistry and endodontics, room no. 204, SGT dental college and hospital, SGT university, Gurugram
Gurgaon
HARYANA
122505
India |
| Phone |
9873122335 |
| Fax |
|
| Email |
drsharma.endo_fds@sgtuniversity.org |
|
Details of Contact Person
Public Query
|
| Name |
Dr. Mallika Rawat |
| Designation |
Post Graduate student |
| Affiliation |
SGT Dental College and Hospital, SGT University |
| Address |
Department of Conservative dentistry and Endodontics, Room no 204, SGT Dental college and hospital, SGT University, Gurugram
Gurgaon
HARYANA
122505
India |
| Phone |
09871213320 |
| Fax |
|
| Email |
rawatmallika98@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Conservative dentistry and Endodontics,SGT Dental college, SGT University, Gurgaon, Haryana 122505, India |
|
|
Primary Sponsor
|
| Name |
SGT University |
| Address |
Department of Conservative Denitstry and Endodontics, Faculty of Dental sciences SGT University Gurgaon Haryana India 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 |
| Dr Mallika Rawat |
SGT Dental Hospital, SGT University |
Dept of conservative dentistry and endodontics, room no. 204
Gurgaon
HARYANA |
09871213320
rawatmallika98@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee- SGT Dental College, Hospital and Research Institute |
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 |
2% Lignocaine with 1:200,000 epinephrine
|
2% Lignocaine with 1:200,000 epinephrine will be given as 1.8ml Inferior alveolar nerve block and 1ml buccal infiltration before initiating Root canal treatment in patients of this group |
| Comparator Agent |
4% Articaine with 1:100,000 epinephrine |
4% Articaine with 1:100,000 epinephrine to be injected- 0.8ml in buccal and lingual infiltration each before initiation Root canal treatment in patients of this group |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
All patients selected will be healthy.
Active pain in first or second mandibular molars
Absence of any periapical radiolucency
No history of trauma to involved tooth
Vital coronal pulp on access opening
|
|
| ExclusionCriteria |
| Details |
All patients selected will not have taken any central nervous system depressants or analgesic medication within last 24 hours.
Patients with periapical pathology
Retreatment cases
Cases with non vital pulp
Pregnancy or lactating patients
Those with allergy to LA or sulphur drugs
Psychiatric patients who are not able to rate the pain on scale
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Double Blind Double Dummy |
|
Primary Outcome
|
| Outcome |
TimePoints |
To evaluate the anaesthetic efficacy of Buccal and Lingual infiltration with 4%Articaine with epinephrine (1:100,000)
|
4 weeks
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To find the best technique that provides maximum anaesthetic efficacy in mandibular molars with symptomatic irreversible pulpitis
|
8 weeks |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
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 1/ Phase 2 |
|
Date of First Enrollment (India)
|
04/02/2025 |
| 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 Yet Recruiting |
| 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
|
This trial will be conducted to compare and evaluate the anaesthetic efficacy of 4% articaine given as buccal infiltration combined with Lingual Infiltration Vs 2% lignocaine given as buccal infiltration combined with Inferior Alveolar Nerve Block in Mandibular Molars with Symptomatic Irreversible Pulpitis.
|