| CTRI Number |
CTRI/2022/02/040040 [Registered on: 04/02/2022] Trial Registered Prospectively |
| Last Modified On: |
03/02/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Management of Deep Carious teeth with lesser invasive treatment procedure |
|
Scientific Title of Study
|
Comparison of pulp capping and Pulpotomy for deep Caries management-Clinical study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Melvin Gabriel E |
| Designation |
MDS 2ND Year |
| Affiliation |
CSI College Of Dental Sciences And Research |
| Address |
Department Of Conservative Dentistry And Endodontics,
Room Number:6,
129,CMH Compound,
Old kuvayarpalayam road,
East veli street
Madurai
TAMIL NADU
625001
India |
| Phone |
9994016951 |
| Fax |
|
| Email |
melvingabriel24@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Melvin Gabriel E |
| Designation |
MDS 2ND Year |
| Affiliation |
CSI College Of Dental Sciences And Research |
| Address |
Department Of Conservative Dentistry And Endodontics,
Room Number:6,
129,CMH Compound,
Old kuvayarpalayam road,
East veli street
Madurai
TAMIL NADU
625001
India |
| Phone |
9994016951 |
| Fax |
|
| Email |
melvingabriel24@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr I Anand Sherwood |
| Designation |
Professor And Head Of The Department |
| Affiliation |
CSI College Of Dental Sciences And Research |
| Address |
Department Of Conservative Dentistry And Endodontics,
Room Number:6,
129,CMH Compound,
Old kuvayarpalayam road,
East veli street
Madurai
TAMIL NADU
625001
India |
| Phone |
9443805150 |
| Fax |
|
| Email |
anand.sherwood@gmail.com |
|
|
Source of Monetary or Material Support
|
| CSI College Of Dental Sciences And Research,129 CMH Compound ,East Veli Street,MADURAI,TAMILNADU 625001 |
|
|
Primary Sponsor
|
| Name |
CSI College Of Dental Sciences And Research |
| Address |
129,CMH Compound,Old Kuvayarpalayam Road,East Veli Street,MADURAI |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Melvin Gabriel E |
CSI College Of Dental Sciences And Research |
Room number:6
Department Of Conservative Dentistry And Endodontics
Madurai
TAMIL NADU |
9994016951
melvingabriel24@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICAL COMMITTEE AND INSTITUTIONAL REVIEW BOARD |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K029||Dental caries, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
BIODENTINE |
Tricalcium Silicate Cement Placed Over Root Canal Orifices Upto 2-3mm Thickness Placed For Entire Period Of Treatment-18months |
| Comparator Agent |
DYCAL |
Calcium Hydroxide Cement Placed Over Pulpal And Axial Walls Upto 1mm Thickness Placed For Entire Period Of Treatment-18months |
|
|
Inclusion Criteria
|
| Age From |
14.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
ONLY PROXIMAL DEEP CARIES MAXILLARY AND MANDIBULAR FIRST AND SECOND MOLAR TEETH WITH HISTORY OF OCCASIONAL SENSITIVITY/PAIN (OR)PAIN/SENSITIVITY EVIDENT ON MASTICATION AND COLD SENSIBLITY TEST RESPONSE OF EXAGGERATED SENSITIVITY OR MILD PAIN WHICH SUBSIDES IMMEDIATELY |
|
| ExclusionCriteria |
| Details |
SYMPTOMATIC IRREVERSIBLE PULPITIS,TEETH WITH NECROTIC PULP AND PATIENTS WITH HISTORY OF ANALGESIC PREMEDICATION FOR PAIN RELIEF |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To observe the difference in clinical and radiographic assessment between pulpotomy and indirect pulp capping procedures in management of symptomatic deep proximal caries in molar teeth |
18 MONTHS |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To access the influence of clinical pulp exposure on the treatment outcome between pulpotomy and pulp capping procedure and to access the survival between pulpotomy and pulp capping procedure |
18 MONTHS |
|
|
Target Sample Size
|
Total Sample Size="220"
Sample Size from India="220"
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
|
N/A |
|
Date of First Enrollment (India)
|
14/02/2022 |
| 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="1"
Months="3"
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
|
Treatment comparison between pulp capping and pulpotomy procedure for symptomatic proximal deep caries molar teeth using calcium hydroxide dycal paste and biodentine
|