| CTRI Number |
CTRI/2020/10/028640 [Registered on: 26/10/2020] Trial Registered Prospectively |
| Last Modified On: |
22/10/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Diagnostic |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Root Canal Treatment |
|
Scientific Title of Study
|
Partial versus full pulpotomy in the treatment of teeth with signs and symptoms indicative of irreversible pulpitis and the predictive value of pulpal biomarkers in determining outcome- A 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 |
Vasudev Ballal |
| Designation |
Professor |
| Affiliation |
Manipal College of Dental Sciences |
| Address |
Department of Conservative Dentistry and Endodontics Manipal College of Dental Sciences Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
09880626167 |
| Fax |
|
| Email |
drballal@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Vasudev Ballal |
| Designation |
Professor |
| Affiliation |
Manipal College of Dental Sciences |
| Address |
Department of Conservative Dentistry and Endodontics Manipal College of Dental Sciences Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
09880626167 |
| Fax |
|
| Email |
drballal@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Vasudev Ballal |
| Designation |
Professor |
| Affiliation |
Manipal College of Dental Sciences |
| Address |
Department of Conservative Dentistry and Endodontics Manipal College of Dental Sciences Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
09880626167 |
| Fax |
|
| Email |
drballal@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Manipal College of Dental Sciences Manipal |
|
|
Primary Sponsor
|
| Name |
Manipal College of Dental Sciences |
| Address |
Manipal College of Dental Sciences Manipal |
| Type of Sponsor |
Research institution |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| University of Dublin |
Trinity College Dublin Ireland |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Vasudev Ballal |
Manipal College of Dental Sciences |
Department of Conservative Dentistry and Endodontics
Udupi
KARNATAKA |
09880626167
drballal@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I95-I99||Other and unspecified disorders of the circulatory system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Full pulpotomy |
Complete coronal pulp tissue is removed |
| Intervention |
Partial pulpotomy |
Partial pulp tissue is removed |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
deep or extremely deep carious lesion radiographically on posterior teeth reaching close to the pulp (inner quarter of dentine i.e. >75%) and signs and symptoms indicative of irreversible pulpitis. |
|
| ExclusionCriteria |
| Details |
Lack of availability for follow up (e.g. moving away), periodontal probing > 5 mm on tooth in question, mild symptoms indicative or reversible pulpitis, bleeding cannot be arrested after 10 minutes. |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| A composite measure, which requires absence of pain, absence of apical periodontitis and absence of internal root resorption to be confirmed by history, clinical examination and radiographic assessment at 1 year. |
1 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Absence of pain (3 & 7 days post-operatively), structural integrity of tooth, no further interventions during 12 month follow up period, no adverse events. MMP9 and IL 6 levels to be correlated with failed cases.
|
1 year |
|
|
Target Sample Size
|
Total Sample Size="114"
Sample Size from India="114"
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 3 |
|
Date of First Enrollment (India)
|
30/10/2020 |
| 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="4"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
In this project, partial pulpotomy versus full pulpotomy will be compared for their clinical success. Post operative pain level will be evaluated at day 3 and 7 after the pulpotomy treatment. MMP 9 and IL 6 will be correlated with the failed cases. |