| CTRI Number |
CTRI/2024/11/076367 [Registered on: 08/11/2024] Trial Registered Prospectively |
| Last Modified On: |
07/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia
Dentistry |
| Study Design |
Other |
|
Public Title of Study
|
Participants will be administered local anesthesia of 0.5 percent of Bupivacaine v/s 4 percent Articaine to compare the success rate of both anesthetic agents in teeth with Symptomatic Irreversible Pulpitis |
|
Scientific Title of Study
|
To evaluate the success rate of 0.5 percent Bupivacaine v/s 4 percent Articaine as anesthetic agents in teeth with Symptomatic Irreversible Pulpitis |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
NIMISHA JAIN |
| Designation |
POST GRADUATE STUDENT |
| Affiliation |
SGT DENTAL COLLEGE HOSPITAL AND RESEARCH INSTITUTE,SGT UNIVERSITY |
| Address |
Room no-204, Department of conservative dentistry and endodontics, SGT University, Gurgaon, Badli road Chandu Bhudera,Gurugram
Gurgaon
HARYANA
122505
India |
| Phone |
07497075504 |
| Fax |
|
| Email |
drnimishajain517@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR MAMTA SINGLA |
| Designation |
PROFESSOR |
| Affiliation |
SGT DENTAL COLLEGE HOSPITAL AND RESEARCH INSTITUTE,SGT UNIVERSITY |
| Address |
Room no-204, Department of conservative dentistry and endodontics, SGT University, Gurgaon, Badli road Chandu Bhudera,Gurugram
Gurgaon
HARYANA
122505
India |
| Phone |
9891381349 |
| Fax |
|
| Email |
mamta.singla@sgtuniversity.org |
|
Details of Contact Person
Public Query
|
| Name |
DR MAMTA SINGLA |
| Designation |
PROFESSOR |
| Affiliation |
SGT DENTAL COLLEGE HOSPITAL AND RESEARCH INSTITUTE,SGT UNIVERSITY |
| Address |
Room no-204, Department of conservative dentistry and endodontics, SGT University, Gurgaon, Badli road Chandu Bhudera,Gurugram
Gurgaon
HARYANA
122505
India |
| Phone |
9891381349 |
| Fax |
|
| Email |
mamta.singla@sgtuniversity.org |
|
|
Source of Monetary or Material Support
|
| SGT Dental College, Hospital and Research Institute, Gurugram, Haryana-122505 |
|
|
Primary Sponsor
|
| Name |
SGT UNIVERSITY |
| Address |
Department of Conservative Dentistry and Endodontics, SGT Dental
College, Hospital and Research Institute, Gurugram,
Haryana-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 NIMISHA JAIN |
SGT Dental College hospital and research institute,SGT University |
Department of Conservative Dentistry and Endodontics, SGT Dental College, Hospital and Research Institute, Gurugram, Haryana-122505
Gurgaon
HARYANA |
07497075504
drnimishajain517@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SGT UNIVERSITY ETHICAL COMMITTEE |
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 |
ARTICAINE |
Articaine will be given as buccal infiltration with the dose of 0.9mL solution to evaluate the success rate and effectivity of anesthesia |
| Intervention |
BUPIVACAINE |
Bupivacaine will be given in IANB nerve block with the dose of 1.8 mL to evaluate the success rate end effectivity of anesthesia |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
Systemically healthy patients.
Mature permanent mandibular posteriors with symptomatic irreversible pulpitis with no periapical radiolucency
Teeth having sufficient tooth structure for adequate isolation.
A vital coronal pulp on access opening
No history of previous endodontic therapy.
No history of trauma to the involved tooth.
|
|
| ExclusionCriteria |
|
|
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 Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Pain Control and Effectivity with Bupivacaine and Articaine |
Before administration of local anesthesia, 15 minutes after administration of anesthesia, during instrumentation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
29/11/2024 |
| 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="2"
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
|
Following the clinical examination and diagnosis of symptomatic irreversible pulpitis, patients will be randomly assigned to one of two groups. The procedure will be explained to the patients, and informed consent will be obtained. Anesthesia will be administered by a postgraduate student, followed by root canal treatment performed by another postgraduate student. Pain evaluation will be done before the administration of local anesthesia, 15 minutes post-administration, and during access cavity preparation to assess the effectiveness and success of the local anesthesia using various techniques. |