| CTRI Number |
CTRI/2022/05/042631 [Registered on: 18/05/2022] Trial Registered Prospectively |
| Last Modified On: |
13/05/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Evaluation of pain during two different anesthetic techniques in dentistry |
|
Scientific Title of Study
|
Comparison of Efficacy of Conventional and Modified Intrapulpal Supplementary Anesthetic Techniques in Patients with Symptomatic Irreversible Pulpitis: A Randomized Clinical Trail. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Rambabu Tanikonda |
| Designation |
Professor, HOD |
| Affiliation |
Drs Sudha and Nageswara Rao Siddhartha Institute Of Dental Sciences |
| Address |
Drs Sudha and Nageswara Rao Siddhartha Institute Of Dental Sciences, Chinoutpalli, Gannavaram Mandal
Krishna
ANDHRA PRADESH
521286
India |
| Phone |
9440364064 |
| Fax |
|
| Email |
rambabumds@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Rambabu Tanikonda |
| Designation |
Professor, HOD |
| Affiliation |
Drs Sudha and Nageswara Rao Siddhartha Institute Of Dental Sciences |
| Address |
Drs Sudha and Nageswara Rao Siddhartha Institute Of Dental Sciences, Chinoutpalli, Gannavaram Mandal
ANDHRA PRADESH
521286
India |
| Phone |
9440364064 |
| Fax |
|
| Email |
rambabumds@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Rambabu Tanikonda |
| Designation |
Professor, HOD |
| Affiliation |
Drs Sudha and Nageswara Rao Siddhartha Institute Of Dental Sciences |
| Address |
Drs Sudha and Nageswara Rao Siddhartha Institute Of Dental Sciences, Chinoutpalli, Gannavaram Mandal
ANDHRA PRADESH
521286
India |
| Phone |
9440364064 |
| Fax |
|
| Email |
rambabumds@gmail.com |
|
|
Source of Monetary or Material Support
|
| Drs Sudha and Nageswara Rao Siddhartha institute of dental sciences |
|
|
Primary Sponsor
|
| Name |
Rambabu Tanikonda |
| Address |
Drs Sudha and Nageswara Rao Siddhartha Institute Of Dental Sciences,Room no 7, Chinoutpalli, Gannavaram Mandal, Andhra Pradesh |
| 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 |
| Rambabu Tanikonada |
Drs Sudha and Nageswara rao Siddhartha Institute of Dental Sciences |
Department of Conservative Dentistry and Endodontics, Room no 7, Chinoutpalli, Gannavaram mandalam
Krishna
ANDHRA PRADESH |
9440364064
rambabumds@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: K040||Pulpitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Conventional Technique |
Intrapulpal anesthesia is given through the syringe directly to the pulp for 10 - 20 seconds.the anesthetic effect is evaluated for one hour. |
| Intervention |
Modified Technique |
During intrapupal anesthesia the syringe needle is placed in the pulp chamber through a small opening created during access preparation and cavity is sealed with composite temporarily without etching and bonding so that positive pressure can be created during release of the anesthetic agent into the pulp chamber for 10 - 20 seconds.the anesthetic effect is evaluated for one hour. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients with symptomatic irreversible pulpitis |
|
| ExclusionCriteria |
| Details |
Pregnant patients
patients with Bleeding disorders, severe systemic complications and
allergic to materials used in this study |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Effectiveness of pulpal anesthesia |
During treatment |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Patients pain perception |
During Treatment |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
25/05/2022 |
| 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
|
none yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Sixty patients with symptomatic irreversible pulpitis after achieving the classic signs of Inferior alveolar nerve block(IANB) and where the block is not effective on exposed pulp tissue are taken in this study. The patients are anaesthetised with Inferior Alveolar Nerve block before starting the Root canal procedure. During access opening, if the IANB is not effective on the exposed pulp tissue, patient complaints of pain where there will be a requirement for intrapulpal supplementary anaesthesia. In the intervention group (n=30), the modified technique will be used. Here during intrapupal anaesthesia, the syringe needle will be placed in the pulp chamber through a small opening created during access preparation and the cavity is sealed with composite temporarily, without etching and bonding so that positive pressure can be created thereby the anaesthetic agent will be penetrated effectively into the pulp tissue, resulting in a painless condition. In the comparator group (n=30), the conventional intrapulpal technique will be used. In this group, Intrapulpal anaesthesia will be given through the syringe directly to the pulp. The time required to anaesthetise the pulpal tissue effectively and the number of times the supplementary intrapulpal anaesthesia is required to achieve the required anaesthetic effect will be compared between both groups. |