| CTRI Number |
CTRI/2022/01/039721 [Registered on: 25/01/2022] Trial Registered Prospectively |
| Last Modified On: |
19/01/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Evaluation of pain in root canal treated teeth bu using two different type of sealers |
|
Scientific Title of Study
|
Comparing the incidence of postoperative pain with resin based sealer and calcium silicate based sealer.A prospective 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 |
Maheswari |
| Designation |
Postgraduate student |
| Affiliation |
Drs.sudha and nageswarao siddhartha institute of dental sciences |
| Address |
Drs.sudha and nageswarao siddhartha institute of dental sciences,
Department of conservative dentistry and endodontics,
Room no:7, chinoutpalli,gannavaram mandal.
Krishna
ANDHRA PRADESH
521286
India |
| Phone |
9100634596 |
| Fax |
|
| Email |
mahi123bds@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr j ravi kumar |
| Designation |
Professor |
| Affiliation |
Drs.sudha and nageswarao siddhartha institute of dental sciences |
| Address |
Drs.sudha and nageswarao siddhartha institute of dental sciences.Department of conservative dentistry and endodontics.room no. 7,chinoutpalli,gannavaram mandal.
Krishna
ANDHRA PRADESH
521286
India |
| Phone |
9440250244 |
| Fax |
|
| Email |
drkumarjanga@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr j ravi kumar |
| Designation |
professor |
| Affiliation |
Drs.sudha and nageswarao siddhartha institute of dental sciences |
| Address |
Drs.sudha and nageswarao siddhartha institute of dental sciences.Department of conservative dentistry and endodontics.room no. 7,chinoutpalli,gannavaram mandal.
Krishna
ANDHRA PRADESH
521286
India |
| Phone |
9440250244 |
| Fax |
|
| Email |
drkumarjanga@gmail.com |
|
|
Source of Monetary or Material Support
|
| Drs.sudha and nageswarao siddhartha institute of dental sciences.Department of conservative dentistry and endodontics.room no. 7,chinoutpalli,gannavaram mandal. |
|
|
Primary Sponsor
|
| Name |
Maheswari |
| Address |
Drs.sudha and nageswarao siddhartha institute of dental sciences.Department of conservative dentistry and endodontics.room no. 7,chinoutpalli,gannavaram mandal. |
| Type of Sponsor |
Other [Myself] |
|
|
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 |
| maheswari |
Drs.sudha and nageswarao institute of dental sciences. |
Drs.sudha and nageswarao siddhartha institute of dental sciences,
Department of conservative
dentistry and endodontics,
Room no.7, Chinoutpalli,
Gannavaram mandal.
Krishna
ANDHRA PRADESH |
9100634596
mahi123bds@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics comitte |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K044||Acute apical periodontitis of pulpal origin, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
ah plus |
root canal sealer |
| Intervention |
bio c sealer |
root canal sealer |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Prolonged positive response to cold test and electric pulp tester
Patients diagnosed with asymptomatic and symptomatic irreversible pulpitis caused by deep carious lesio |
|
| ExclusionCriteria |
| Details |
Patients who refuse to participate this study
Medically compromised patients
The presence of open apex, presence of calcification,
presence of resorption
Patients who had allergic sensitivity to local anaesthetic
Pregnant patients and patients in lactation period |
|
|
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 |
| postoperative pain |
At 6, 12, 24 and 48 hrs, and 3, 4, 5, 6 and 7 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| analgesic consumption |
one week |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "30"
Final Enrollment numbers achieved (India)="30" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
02/02/2022 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="1"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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 postoperative pain by using calcium silicate based sealer (bio c sealer )and epoxy resin based sealer (AH plus sealer) at 6, 12, 24 and 48 h, and 3, 4, 5, 6 and 7 days. the number of patients taking in this study are 30. |