| CTRI Number |
CTRI/2024/07/069850 [Registered on: 03/07/2024] Trial Registered Prospectively |
| Last Modified On: |
02/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Evaluating outcome of two pukp capping agents in type 2 diabetic patients. |
|
Scientific Title of Study
|
Clinical And Radiographic Evaluation
Of Two Pulp Capping Agents In
Permanent Teeth Of Type II Diabetic
Patients With Carious Pulp Exposure-
A Randomized Control 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 |
Dr Narendra Babu E |
| Designation |
PG Resident |
| Affiliation |
K V G Dental College and Hospital |
| Address |
Room 6 Department of conservative dentistry and endodontics
K V G Dental College and Hospital
Kuringibhag Sullia
Dakshina Kannada
KARNATAKA
574327
India |
| Phone |
9964774139 |
| Fax |
|
| Email |
drnarendrababu07@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Moksha Nayak |
| Designation |
Professor and Principal |
| Affiliation |
KVG Dental College and Hospital |
| Address |
Room 6 Department of conservative Dentistry and endodontics
KVG DENTAL COLLEGE AND HOSPITAL
Kuranjibhag sullia
Dakshina Kannada
KARNATAKA
574327
India |
| Phone |
9448026828 |
| Fax |
|
| Email |
moksha.nayak@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Narendra Babu E |
| Designation |
PG Resident |
| Affiliation |
KVG Dental college and Hospital |
| Address |
Room 6
Department of conservative Dentistry and Endodontics
KVG Dental college and Hospital
Kuranjibhag Sullia
Dakshina Kannada
KARNATAKA
574327
India |
| Phone |
9964774139 |
| Fax |
|
| Email |
drnarendrababu07@gmail.com |
|
|
Source of Monetary or Material Support
|
| K V G Dental College and Hospital Kurinjibhag sullia Dakshin Kannada Karnatakan574327 |
|
|
Primary Sponsor
|
| Name |
Narendra Babu E |
| Address |
KVG Dental College and Hospital Kuranjibhag Sullia Dakshin Kannada Karnataka 574327 |
| Type of Sponsor |
Other [] |
|
|
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 Narendra Babu E |
KVG Dental College and Hospital |
Room no 6 Department of Conservative Dentistry and Endodontics
KURINJIBHAG SULLIA
Dakshina Kannada
KARNATAKA |
9964774139
drnarendrababu07@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE K V G Dental College and Hospital |
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 |
| Comparator Agent |
BIODENTIN AND PRF MIX |
BIODENTIN+PRF Will be used as pulp capping agent once based on size of pulp exposure |
| Intervention |
BIODENTINE |
BIODENTIN Will be used as pulp capping agent once based on size of pulp exposure |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
Patients under the following age group with pukp exposure on caries exposure |
|
| ExclusionCriteria |
| Details |
1 Pregnant and lactating mothers.
2 Teeth with cracks and defects.
3 Presence of signs and symptoms of irreversible pulpitis. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| It is assumed to improve clinical outcomes such as pain Sensitivity |
1 WEEK 1 MONTH 6 MONTHS |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| It is expected to Give Good Thickness of Dentin Bridge Formation With improved Clinical Outcomes after application of Biodentine & PRF |
1 week 1 month 6 months 1Year |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
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 4 |
|
Date of First Enrollment (India)
|
18/07/2024 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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
|
Basically this is randomised control trial comparing two different direct pulp capping agents in type 2 diabetes patients over a period of 6 months Aim-to know clinical outcomes and its effect on direct pulp capping To increase success of direct pulp capping using biological accepted membrane and material
|