| CTRI Number |
CTRI/2018/05/013932 [Registered on: 17/05/2018] Trial Registered Retrospectively |
| Last Modified On: |
09/04/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Evaluation of pain after endodontic obturation with three different rootcanal sealers:A randomized control trail |
|
Scientific Title of Study
|
Evaluation of postobturation pain in endodontically treated teeth with three sealers: A radomized control trail |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
AMBIKA SIGADAM |
| Designation |
post graduate student |
| Affiliation |
VISHNU DENTAL COLLEGE |
| Address |
Department of Conservative Dentistry and Endodontics,
Vishnu Dental College,
Bhimavaram
Department of Conservative Dentistry and Endodontics,
Vishnu Dental College,
Bhimavaram
West Godavari
ANDHRA PRADESH
534202
India |
| Phone |
9100808662 |
| Fax |
8816250894 |
| Email |
ambika.sigadam@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
KALYAN SATISH R |
| Designation |
PROFESSOR |
| Affiliation |
VISHNU DENTAL COLLEGE |
| Address |
Department of Conservative Dentistry and Endodontics,
Vishnu Dental College,
Bhimavaram
Department of Conservative Dentistry and Endodontics,
Vishnu Dental College,
Bhimavaram
West Godavari
ANDHRA PRADESH
534202
India |
| Phone |
9848717815 |
| Fax |
8816250894 |
| Email |
rkalyansatish@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
AMBIKA SIGADAM |
| Designation |
post graduate student |
| Affiliation |
VISHNU DENTAL COLLEGE |
| Address |
Department of Conservative Dentistry and Endodontics,
Vishnu Dental College,
Bhimavaram
Department of Conservative Dentistry and Endodontics,
Vishnu Dental College,
Bhimavaram
West Godavari
ANDHRA PRADESH
534202
India |
| Phone |
9848717815 |
| Fax |
8816250894 |
| Email |
ambika.sigadam@gmail.com |
|
|
Source of Monetary or Material Support
|
| VISHNU DENTAL COLLEGE, VISHNU EDUCATIONAL SOCIETY, VISHNUPUR,BHIMAVARAM 534201 |
|
|
Primary Sponsor
|
| Name |
ambika sigadam |
| Address |
post graduate student, department of conservative dentistry and endodontics, vishnu dental college, bhimavaram. |
| Type of Sponsor |
Other [self funded] |
|
|
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 |
| ambika sigadam |
department of conservative dentistry and endodontics |
room number 7, Department of conservative dentistry and endodontics, vishnu dental college, bhimavaram
West Godavari
ANDHRA PRADESH |
9100808662
ambika.sigadam@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICAL COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Patients advised for root canal therapy, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
AH PLUS ROOT CANAL SEALER |
AH PLUS SEALER: it is epoxy resin based sealer
|
| Intervention |
ENDOSEQUENCE BC SEALER |
ENDOSEQUENCE BC SEALWER is a bioaggregate sealer |
| Intervention |
MTA sealer |
MTA SEALER is a mta based sealer |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
patients above 18 years old who require endodontic treatment, without systemic diseases or allergic reaction |
|
| ExclusionCriteria |
| Details |
severe periodontal disease or resorption in related tooth
teeth with periapical radiolucencies
teeth planned for the single visit endodontics |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess postobturation pain using VAS on 1st day of obturation |
To assess postobturation pain using VAS on 1st day of obturation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| to assess post obturation pain on 3rd , 5th and 7th day after obturation |
3rd, 5th and 7th day after obturation |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
Final Enrollment numbers achieved (Total)= "90"
Final Enrollment numbers achieved (India)="90" |
|
Phase of Trial
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
18/01/2018 |
| Date of Study Completion (India) |
30/03/2018 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="4"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
not yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
pain control before and after root canal treatment is important. post endodontic pain is multifactorial, this study was designed to determine the effect of sealers used during obturation on post endodontic pain and evaluate them using vas scale. There is very less literature available in evaluating the relationship between the newer endodontic sealers and post obturation pain hence this study is designed to obtain the association between different endodontic sealers and post endodontic pain using VAS |