| CTRI Number |
CTRI/2024/06/068313 [Registered on: 04/06/2024] Trial Registered Prospectively |
| Last Modified On: |
31/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Clinical Evaluation of resin- based calcium direct pulp capping materials. |
|
Scientific Title of Study
|
Evaluation Of Clinical Success of Three Resin Based Calcium Silicate Materials as Direct Pulp Capping Agents: A Randomized Clinical trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Yellapu Shenkari Indumathi |
| Designation |
Post Graduate Student |
| Affiliation |
Drs. Sudha & Nageswara Rao Siddhartha Institute of Dental Sciences |
| Address |
Drs. Sudha & Nageswara Rao Siddhartha Institute of Dental Sciences
Department of Conservative Dentistry and Endodontics
Room No. 7
Gannavaram 521286
Krishna
ANDHRA PRADESH
521286
India |
| Phone |
7032491930 |
| Fax |
|
| Email |
indumathi090@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Janga Ravi Kumar |
| Designation |
Professor |
| Affiliation |
Drs. Sudha & Nageswara Rao Siddhartha Institute of Dental Sciences |
| Address |
Drs. Sudha & Nageswara Rao Siddhartha Institute of Dental Sciences
Department of Conservative Dentistry and Endodontics
Room No. 7
Gannavaram 521286
NIL
Krishna
ANDHRA PRADESH
521286
India |
| Phone |
7032491930 |
| Fax |
|
| Email |
drkumarjanga@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Yellapu Shenkari Indumathi |
| Designation |
Post Graduate Student |
| Affiliation |
Drs. Sudha & Nageswara Rao Siddhartha Institute of Dental Sciences |
| Address |
Drs. Sudha & Nageswara Rao Siddhartha Institute of Dental Sciences
Department of Conservative Dentistry and Endodontics
Room No. 7
Gannavaram 521286
NIL
Krishna
ANDHRA PRADESH
521286
India |
| Phone |
7032491930 |
| Fax |
|
| Email |
indumathi090@gmail.com |
|
|
Source of Monetary or Material Support
|
| Yellapu Shenkari Indumathi
Post graduate student
Drs. Sudha & Nageswara Rao Siddhartha Institute of Dental Sciences
Department of Conservative Dentistry and Endodontics
Room No. 7
Gannavaram 521286
Chinnautpalli
Vijayawada
AndhraPradesh |
|
|
Primary Sponsor
|
| Name |
Yellapu Shenkari Indumathi |
| Address |
Drs. Sudha & Nageswara Rao Siddhartha Institute of Dental Sciences
Department of Conservative Dentistry and Endodontics
Room No. 7
Gannavaram 521286
Chinnaoutpalli
Vijayawada
AndhraPradesh |
| 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 |
| YELLAPU SHENKARI INDUMATHI |
DRS. SUDHA AND NAGESWARA RAO SIDDHARTHA INSTITUTE OF DENTAL SCIENCES |
DRS.SUDHA AND NAGESWARA RAO SIDDHRATHA INSTITUTE OF DENTAL SCIENCES, CHINAOUTPALLI, GANNAVRAM, VIJAYAWADA, KRISHNA DISTRICT, ANDHRA PRADESH, INDIA, 521286
ROOM NO 7
DEPARTMENT OF CONSERVATIVE DENTISTRY AND ENDODONTICS,
PG BLOCK.
Krishna
ANDHRA PRADESH |
7032491930
indumathi090@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Drs. Sudha & Nageswara Rao Siddhartha Institute of Dental Sciences Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K029||Dental caries, unspecified, (2) ICD-10 Condition: K029||Dental caries, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Mta Lc Dentigrate Dentact solutions private limited |
MTA LC Dentigrate is a resin based calcim silicate recently intoduced material designed for pulp protection like pulp capping and perforation repair material.MTA LC will be applied and lightcured immediately for 60 seconds |
| Comparator Agent |
Theracal Lc Bisco incorporations |
Theracal LC is a resin based calcium silicate paste specially designed to be used as a Pulp Capping Material for pulp protection and additition of resin improves fast setting can be cured in less than 30 seconds after appication. |
| Intervention |
Theracal PT Bisco incorporations |
Theracal PT is a pulp protection material specially designed for pulpotomy procedures and it can also be approved for other pulp therapies like direct pulp capping therapy and unlike theracal lc it is a dual cure resin-based material improving the handling properties and working time. Theracal PT material is applied, and light cured for 40 seconds |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
patients who are asymptomatic/symptomatic reversible pulpitis with deep dental caries in posterior teeth close to pulp chamber and bleeding easily controlled after pulp exposure |
|
| ExclusionCriteria |
| Details |
any h/o of spontaneous pain, periapical lesion and bleeding not controlled after pulp exposure |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| MORE THAN 75% OF PATIENTS RECIIEVING DIRECT PULP CAPPING BY THE MATERIALS USED IN THE STUDY WILL BE CAPABLE OF PRESERVING THE PULP VITALITY |
WITHIN 3 MONTHS |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| IN MORE THE 75% PATIENTS THE SIGNS AND SYMPTOMS OF PULPITIS SUCH AS TOOTH ACHE WILL BE CURED |
WITHIN 3 MONTHS |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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/ Phase 4 |
|
Date of First Enrollment (India)
|
15/06/2024 |
| 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="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
MY THESIS IS TO EVALUATE THE SUCCESS OF THREE LIGHT CURING PULP CAPPING MATERIALS USED IN CLINICAL DENTAL PRACTICE AND EVALUATE THEIR SUCCESS IN PRESERVING THE DENTAL PULP VITALITY AS PULP IS A SPECIAL CONNECTIVE TISSUE IN THE TOOTH REGULATING SERVAL FUNTIONS OF TOOTH LIKE BLOOD SUPPLY, NUTRIENT SUPPLY, CELLS AND FACTORS PARTICIPATING IN REPAIR AND REGENRATION AND IT IS THE ONLY TISSUE IN HUMAN TOOTH CAPABLE OF REGENERTAION AND THEREFORE PRESERVING THE DENTAL PULP CAN PRESERVE THE TOOTH IN A HEALTHY STATE IN THE ORAL CAVITY. MY STUDY HYPOTHESIS IS THERE WILL BE NO SIGNIFICANT DIFFERENCE IN THE CLINICAL SUCCESS AMONG THE THREE DIRECT PULP CAPPING MATERIALS 1. THERACAL LC 2. THERACAL PT 3. MTA LC DENTIGRATE. |