| CTRI Number |
CTRI/2023/07/054607 [Registered on: 03/07/2023] Trial Registered Prospectively |
| Last Modified On: |
28/06/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Estimating the effectiveness of star pen anesthetic system versus routine anesthetic systems on pain sensation of the patients |
|
Scientific Title of Study
|
Evaluation of the efficacy of star pen electronic anesthetic delivery system versus traditional injection systems on the pain perception of the patient |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
RUDRAPAKA SIRISHA |
| Designation |
POST GRADUATE STUDENT |
| Affiliation |
ST JOSEPH DENTAL COLLEGE |
| Address |
DEPARTMENT OF CONSERVATIVE DENTISTRY AND ENDODONTICS, ST JOSEPH DENTAL COLLEGE AND HOSPITAL, DUGGIRALA, ELURU
DEPARTMENT OF CONSERVATIVE DENTISTRY AND ENDODONTICS, ST JOSEPH DENTAL COLLEGE AND HOSPITAL, DUGGIRALA, ELURU
West Godavari
ANDHRA PRADESH
534003
India |
| Phone |
9441833437 |
| Fax |
|
| Email |
siri.rudrapaka.96@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr V B Srinidhi |
| Designation |
PROFESSOR |
| Affiliation |
ST JOSEPH DENTAL COLLEGE AND HOSPITAL |
| Address |
DEPARTMENT OF CONSERVATIVE DENTISTRY AND ENDODONTICS, ST JOSEPH DENTAL COLLEGE AND HOSPITAL, DUGGIRALA, ELURU
DEPARTMENT OF CONSERVATIVE DENTISTRY AND ENDODONTICS, ST JOSEPH DENTAL COLLEGE AND HOSPITAL, DUGGIRALA, ELURU
West Godavari
ANDHRA PRADESH
534003
India |
| Phone |
9030504693 |
| Fax |
|
| Email |
vbnidhi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr V B Srinidhi |
| Designation |
Professor |
| Affiliation |
ST JOSEPH DENTAL COLLEGE AND HOSPITAL |
| Address |
DEPARTMENT OF CONSERVATIVE DENTISTRY AND ENDODONTICS, ST JOSEPH DENTAL COLLEGE AND HOSPITAL, DUGGIRALA, ELURU
DEPARTMENT OF CONSERVATIVE DENTISTRY AND ENDODONTICS, ST JOSEPH DENTAL COLLEGE AND HOSPITAL, DUGGIRALA, ELURU
West Godavari
ANDHRA PRADESH
534003
India |
| Phone |
9030504693 |
| Fax |
|
| Email |
vbnidhi@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Conservative dentistry and Endodontics,St Joseph Dental College and Hospital,Duggirala, Eluru |
|
|
Primary Sponsor
|
| Name |
Rudrapaka Sirisha |
| Address |
Department of Conservative dentistry and Endodontics,St Joseph Dental College and Hospital,Duggirala, Eluru, pincode:534003 |
| Type of Sponsor |
Other [SELF] |
|
|
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 |
| Rudrapaka Sirisha |
ST JOSEPH DENTAL COLLEGE |
Room no:5,
Department of Conservative dentistry and Endodontics,St Joseph Dental College and Hospital,Duggirala, Eluru
West Godavari
ANDHRA PRADESH |
9441833437
siri.rudrapaka.96@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| St Joseph Dental College institutional ethical committee |
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 |
not applicable |
not applicable |
| Intervention |
septodont metallic self-aspirating syringe |
to determine efficacy on pain perception |
| Intervention |
star pen electronic anesthesia |
efficacy of star pen electronic anesthesia system on pain perception |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Inclusion criteria include mandibular molars with symptomatic irreversible pulpitis showing a positive response to EPT and cold tests, both male and female patients of age group 18-65 years |
|
| ExclusionCriteria |
| Details |
The specific exclusion criteria include radiographs with periapical changes, patients showing positive aspiration during local anesthesia administration, medically compromised patients. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| efficacy of star pen anesthetic delivery system |
one year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| not applicable |
not applicable |
|
|
Target Sample Size
|
Total Sample Size="45"
Sample Size from India="45"
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
|
N/A |
|
Date of First Enrollment (India)
|
10/07/2023 |
| 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 Applicable |
| 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
|
The aim of the study is to compare the anesthesia efficiency of inferior alveolar nerve block performed using Star pen electronic anesthetic delivery system, Septodont syringe, and conventional syringe. Patients coming to the OPD of the Department of Conservative Dentistry and Endodontics of St. Joseph Dental College, Duggirala, Eluru will be taken for the study. Signed informed consent forms will be taken from all the patients. Patients diagnosed with symptomatic irreversible pulpitis confirmed with EPT and cold tests will be selected. Inclusion criteria include mandibular molars with symptomatic irreversible pulpitis, both male and female patients of age 18-65 years. The specific exclusion criteria include radiographs with periapical changes, patients showing positive aspiration during local anesthesia administration, and medically compromised patients who will be excluded from the study. In this controlled trial, the pain perception of the patients will be assessed using the visual analogue scale during needle insertion, during local anesthesia administration and during the treatment. The results will be statistically analyzed . |