| CTRI Number |
CTRI/2023/02/049703 [Registered on: 14/02/2023] Trial Registered Prospectively |
| Last Modified On: |
27/01/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Clinical And Radiological Comparison of Pro Root MTA, TheraCal LC, TheraCal PT As Direct Pulp Capping Agent |
|
Scientific Title of Study
|
Clinical And Radiological Comparative Evaluation Of Different Calcium Silicate Based Materials Pro Root MTA, TheraCal LC And TheraCal PT As Direct Pulp Capping Agent In Carious Permanent Tooth: 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 |
Dr Radhika Charhate |
| Designation |
Post Graduate Student |
| Affiliation |
Swargiya Dadasaheb Kalmegh Smruti Dental College And Hospital Nagpur |
| Address |
2nd floor Room no.206 Department of Conservative Dentistry And Endodontics, Swargiya Dadasaheb Kalmegh Smruti Dental College And Hospital Nagpur.
Nagpur
MAHARASHTRA
441110
India |
| Phone |
9588469297 |
| Fax |
|
| Email |
radhikacharhate445@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vandana Gade |
| Designation |
Professor |
| Affiliation |
Swargiya Dadasaheb Kalmegh Smruti Dental College And Hospital Nagpur |
| Address |
2nd floor Room no.206 Department of Conservative Dentistry And Endodontics, Swargiya Dadasaheb Kalmegh Smruti Dental College And Hospital Nagpur.
Nagpur
MAHARASHTRA
441110
India |
| Phone |
9370327036 |
| Fax |
|
| Email |
gade.vandana@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vandana Gade |
| Designation |
Professor |
| Affiliation |
Swargiya Dadasaheb Kalmegh Smruti Dental College And Hospital Nagpur |
| Address |
2nd floor Room no.206 Department of Conservative Dentistry And Endodontics, Swargiya Dadasaheb Kalmegh Smruti Dental College And Hospital Nagpur.
Nagpur
MAHARASHTRA
441110
India |
| Phone |
9370327036 |
| Fax |
|
| Email |
gade.vandana@gmail.com |
|
|
Source of Monetary or Material Support
|
| Swargiya Dadasaheb Kalmegh Smruti Dental College And Hospital, Wanadongri, Nagpur |
|
|
Primary Sponsor
|
| Name |
Dr Radhika Charhate |
| Address |
2nd floor, room no 206, Department of Conservative Dentistry And Endodontics, Swargiya Dadasaheb Kalmegh Smruti Dental College Nagpur,441110 |
| Type of Sponsor |
Other [Self] |
|
|
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 |
| Dr Radhika Charhate |
Swargiya dadasaheb kalmegh smruti dental college and hospital nagpur |
2nd floor, Room no 206, Swargiya Dadasaheb Kalmegh Smruti Dental College And Hospital,Wanadongri, Nagpur
Nagpur
MAHARASHTRA |
9588469297
radhikacharhate445@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 |
(1) ICD-10 Condition: K025||Dental caries on pit and fissure surface, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
PRO-ROOT MTA |
TheraCal LC, TheraCal PT as a Direct Pulp Capping Agent |
| Comparator Agent |
TheraCal LC, TheraCal PT |
TheraCal LC, TheraCal PT as a Direct Pulp Capping Agent |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
deep carious lesion, healthy co-operative patient, caries to the occlusal surface, Positive response to thermal and electric pulp tests,Sensitivity to cold food,.No radiographic evidence of periapical pathology
|
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To evaluate and compare clinically Pro Root MTA, Theracal LC and Theracal PT as a direct
pulp capping agent in carious permanent teeth after 1st,6th
,12th month interval. |
To evaluate and compare clinically Pro Root MTA, Theracal LC and Theracal PT as a direct
pulp capping agent in carious permanent teeth after 1st,6th
,12th month interval. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To evaluate and compare radiologically Pro Root MTA, Theracal LC and Theracal PT as a direct pulp capping agent in carious permanent tooth after 1st,6th,12th month interval. |
To evaluate and compare radiologically Pro Root MTA, Theracal LC and Theracal PT as a direct pulp capping agent in carious permanent tooth after 1st,6th,12th month interval. |
|
|
Target Sample Size
|
Total Sample Size="36"
Sample Size from India="36"
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)
|
05/03/2023 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Direct pulp capping (DPC) is a clinical procedure involving the placement of a biomaterial which aims to maintain dental pulp vitality by stimulating the formation of tertiary dentin as a hard-tissue barrier protector. Although many previous studies have done on Pro Root MTA and TheraCal LC as a direct pulp capping agent, but there is limited data available regarding MTA, TheraCal LC and TheraCal PT as a direct pulp capping agent. Group A (Pro Root MTA group)- MTA will be mixed according to manufacturer’s instructions (i.e., 1:3 water / powder ratio) and applied over an exposed site with a sterile carrier. Cotton pellet soaked in normal saline will be placed over MTA and the cavity will be sealed temperorily with intermediate restorative material Orafil G (prevest denpro, jammu and kashmir, india), after 24 hours the setting of MTA will be evaluated and direct composite restoration tetric n-ceram and tetric n-bond self-etch, (ivoclar vivadent, india) will be placed. Group B (TheraCal LC) -TheraCal LC will be delivered at the exposure site according to the manufacturer’s instructions. Resin Modified Glass Ionomer Cement (RMGIC) will be placed and patient will be recall after 3 days for permanent restoration with Composite (Tetric n-ceram, Ivoclar Vivadent, India) restoration. Group C (TheraCal PT) -TheraCal PT will be delivered at the exposure site according to the manufacturer’s instructions. Resin Modified Glass Ionomer Cement (RMGIC) will be placed and patient will be recall after 3 days for permanent restoration with Composite (Tetric n-ceram, Ivoclar Vivadent, India) restoration. The patients will be recall for Clinical and Radiological evaluation after 1,6,12 months intervals. Clinical evaluation will be perfomed at 1st,6th and 12th months after DPC for history of spontaneous pain, sensibility status of teeth, discoloration of teeth, restoration status, surface texture, anatomic form, secondary caries, post-operative sensitivity, marginal discoloration and marginal integrity. Radiographic evaluation will be perfomed at 1st,6th and 12th months. After 1 st,6 th and 12th months of direct pulp capping, digital periapical radiographs will be taken and submitted to image analysis CoralDRAW X7 Software (coral corporation, Ontario, Canada) 1 st - and 6 th -month radiographs will be overlapped. Radiographs will be adjusted in the software to fit in the measurement of 41 mm ×31mm.Qualitative assessment of the radiograph will be done to find whether the reparative dentin is visible or not. |