| CTRI Number |
CTRI/2023/03/050392 [Registered on: 06/03/2023] Trial Registered Prospectively |
| Last Modified On: |
01/03/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Dentistry] |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
comparing the post-operative pain incidence after the single and multiple visit root canal therapy by using a calcium silicate based sealer- A Randomised clinical trial |
|
Scientific Title of Study
|
Comapring The Incidence Of Post-operative pain after single visit and multiple vist root canal therapy with calcium silicate based sealer- A Randomised Clinical Trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Pravallika Reddibathini |
| Designation |
Postgraduate student |
| Affiliation |
drs sudha and nageswara rao siddhartha institute of dental sciences |
| Address |
DRS Sudha and nageswararao siddhartha institute of dental sciences
Department of conservative dentistry and endodontics
chinaoutpalli
gannavaram mandal
Department of conservative dentistry and endodontics
chinaoutpalli
gannavaram mandal
Krishna
ANDHRA PRADESH
521286
India |
| Phone |
9704234700 |
| Fax |
|
| Email |
pravallikapappu17@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrJRavi Kumar |
| Designation |
Professor |
| Affiliation |
drs sudha and nageswara rao siddhartha institute of dental sciences |
| Address |
DRS Sudha and nageswararao siddhartha institute of dental sciences
Department of conservative dentistry and endodontics
chinaoutpalli
gannavaram mandal
Department of conservative dentistry and endodontics
chinaoutpalli
gannavaram mandal
Krishna
ANDHRA PRADESH
521286
India |
| Phone |
9440250244 |
| Fax |
|
| Email |
drkumarjanga@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DrJRavi Kumar |
| Designation |
Professor |
| Affiliation |
drs sudha and nageswara rao siddhartha institute of dental sciences |
| Address |
DRS Sudha and nageswararao siddhartha institute of dental sciences
Department of conservative dentistry and endodontics
chinaoutpalli
gannavaram mandal
Department of conservative dentistry and endodontics
chinaoutpalli
gannavaram mandal
Krishna
ANDHRA PRADESH
521286
India |
| Phone |
9440250244 |
| Fax |
|
| Email |
drkumarjanga@gmail.com |
|
|
Source of Monetary or Material Support
|
| Drs SUDHA AND NAGESWARA RAO SIDDHARTHA INSTITUTE OF DENTAL SCIENCES DEPARTMENT OF CONSERVATIVE DENTISTRY AND ENDODONTICS CHINOUTAPALLI GANNAVARAM MANDAL KRISHNA DISTRICT ANDHRA PRADESH |
|
|
Primary Sponsor
|
| Name |
Pravallika Reddibathini |
| Address |
DRS.Sudha and nageswararao siddhartha institute of dental sciences
Gnnavaram |
| Type of Sponsor |
Other [myelf] |
|
|
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 |
| Pravallika Reddibathini |
drs sudha and nageswararo siddhartha institute of dental sciences |
Drs SUDHA AND NAGESWARA RAO SIDDHARTHA INSTITUTE OF DENTAL SCIENCES DEPARTMENT OF CONSERVATIVE DENTISTRY AND ENDODONTICS CHINOUTAPALLI GANNAVARAM MANDAL KRISHNA DISTRICT ANDHRA PRADES
Krishna
ANDHRA PRADESH |
9704234700
pravallikapappu17@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethical conmmittee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Acute apical periodontitis of pulpal origin |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
ceraseal root canal sealer |
single vist and multiple visit root canal therapy |
| Comparator Agent |
single visit root canal therapy |
multiple visit root canal therapy |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients requiring endodontic treatment
Teeth with completely formed apices
Teeth with symptomatic irreversible pulpitis |
|
| ExclusionCriteria |
| Details |
Pregnant or lactating females
Medically compromised patients
Patients with open apex,calcification,resorption
Patients allergic to materials used in the study |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Post operative pain |
at 6,12,24,48,72hrs and 1 week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Analgesic consumption |
at 6,12,24,48,72hrs and 1 week |
|
|
Target Sample Size
|
Total Sample Size="44"
Sample Size from India="44"
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)
|
07/03/2023 |
| 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="0"
Months="1"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
not yet started |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
In this study, Comparing the incidence of post-operative pain after single visit and multiple visit root canal therapy with a calcium silicate based sealer at 6,12,24,48,72hrs and 1 week time interval Number of patients taking in this study are 44 |