| CTRI Number |
CTRI/2022/11/047184 [Registered on: 10/11/2022] Trial Registered Prospectively |
| Last Modified On: |
04/11/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
PAIN AFTER ROOT CANALAFTER USING 2 DIFFERENT FILLING MATERIAL |
|
Scientific Title of Study
|
COMPARATIVE EVALUATION OF POST OPERATIVE PAIN AFTER ROOT CANAL OBTURATION USING RESIN BASED SEALER (AH PLUS) AND BIOCERAMIC SEALER (IROOT SP) IN ADULT MANDIBULAR MOLARS USING VISUAL ANALOG SCALE: A DOUBLE BLINDED RANDOMIZED CONTROLLED TRIAL |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
SHREYA SIVASAILAM |
| Designation |
Postgraduate student |
| Affiliation |
PG STUDENT |
| Address |
Room no 302 Department of conservative dentistry and endodontics
Bharati vidyapeeth dental college and hospital , sector 7 belpaada , Navi Mumbai
Bharati Vidyapeeth Dental college and hospital Navi Mumbai
Raigarh
MAHARASHTRA
400614
India |
| Phone |
|
| Fax |
|
| Email |
shreyasiva@ymail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ashish Jain |
| Designation |
PROFESSOR AND HOD |
| Affiliation |
Professor and Head of the department |
| Address |
Room no 302 , Department of conservative dentistry and Endodontics Bharati Vidyapeeth dental college and hospital, sector 7 , Belpada, Navi Mumbai
Department of conservative dentistry and Endodontics Bharati vidyapeeth dental college and hospital , Navi Mumbai
Raigarh
MAHARASHTRA
400614
India |
| Phone |
|
| Fax |
|
| Email |
drakjain5@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ashish Jain |
| Designation |
PROFESSOR AND Head of the Department |
| Affiliation |
PROFESSOR AND HOD |
| Address |
Room no 302 DEPARTMENT OF CONSERVATIVE DENTISTRY AND ENDODONTICS Bharati Vidyapeeth dental college and hospital, sector 7 , Belpada
Raigarh
MAHARASHTRA
400614
India |
| Phone |
|
| Fax |
|
| Email |
drakjain5@gmail.com |
|
|
Source of Monetary or Material Support
|
| DR SHREYA SIVASAILAM
BHARATI VIDYAPEETH Dental College and Hospital , sector 7 Belpada Navi Mumbai |
|
|
Primary Sponsor
|
| Name |
SHREYA SIVASAILAM |
| Address |
room no 302, Department of Conservative Dentistry and Endodontics , Bharati Vidyapeeth dental college and hospital , sector 7 , Belpada, Navi Mumbai |
| Type of Sponsor |
Other [SELF] |
|
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Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DR SHREYA SIVASAILAM |
BHARATI VIDYAPEETH DENTAL COLLEGE AND HOSPITAL |
Department of conservative dentistry and Endodontics Room no 302
Sector 7, CBD Belapur, Navi Mumbai, Maharashtra 400614
Raigarh
MAHARASHTRA |
8356882443
shreyasiva@ymail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| BIOMEDICAL ETHICS COMMITEE |
Approved |
|
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Regulatory Clearance Status from DCGI
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K040||Pulpitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Root canal obturation with AH Plus sealer |
The canals will be obturated with AH plus sealer along with gutta percha using a single cone technique.
Accessory cones will be passively placed in case of wide canals.
• Then, the teeth will be restored with a composite and the occlusion will be checked.
A final radiograph will be taken and obturation will be checked by the operator
Root canal was done in single visit .
Pain scores were measured after 24 hours, 48hours and 7days |
| Comparator Agent |
Root canal obturation with Bioceramic sealer (IROOT SP, Innovative BioCeramix, Inc) |
The canals will be obturated with bio ceramic sealer along with gutta percha using a single cone technique.
Accessory cones will be passively placed in case of wide canals.
Then, the teeth will be restored with a composite and the occlusion will be checked.
A final radiograph will be taken and obturation will be checked by the operator
Root canal was done in single visit . Pain scores were measured after 24 hours, 48hours and 7days |
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Subjects having a mandibular molar tooth with Chronic irreversible pulpitis with no signs of apical periodontitis needing primary endodontic treatment.
Cooperative health subjects who are willing to participate in the study and sign the consent form.
|
|
| ExclusionCriteria |
| Details |
- Subjects with uncontrolled systemic diseases or allergies.
- History of previous root canal treatment.
- Presence of swelling or sinus tracts.
- Presence of severe periodontal disease.
- Periapical radiolucency.
- Subjects who’ve taken analgesics within the last 3 days.
- Subjects allergic to local anesthesia.
- Subjects unwilling to sign the consent form.
|
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Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| POST OPERATIVE PAIN MEASUREMENT USING VISUAL ANALOG SCALE |
7 DAYS |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| ANALGESICS TAKEN IF ANY |
7 DAYS |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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 2 |
|
Date of First Enrollment (India)
|
14/11/2022 |
| 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="0"
Months="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Will be published after the study is completed |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
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Brief Summary
|
The aim of this study is to compare the occurrence and intensity of post-operative pain following root canal obturation using a Bioceramic (IROOT SP, Innovative BioCeramix, Inc) and a resin-based endodontic sealer (AH plus) using visual analog scale (VAS). Root canal treatment will be performed followed by obturation using 2 different sealers. The post operative pain will be assessed using visual analog scale in either groups .Also the number of analgesics taken in either groups will be noted. Double blinding will be done using manually generated sealed envelopes. |