| CTRI Number |
CTRI/2025/02/081352 [Registered on: 27/02/2025] Trial Registered Prospectively |
| Last Modified On: |
20/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of two medicaments MTA and recombinant platelet derived growth factor(rh PDGF BB) in Deep caries management |
|
Scientific Title of Study
|
Efficacy of MTA and Recombinant human platelet derived growth factor(rh PDGF- BB) as pulp treatment agents - A randomized controlled 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 ANITHA T |
| Designation |
Post-graduate student |
| Affiliation |
KSR Institute of Dental Science and Research,Tiruchengode. |
| Address |
Department of Conservative Dentistry and Endodontics,
KSR Institute of Dental Science and Research,
Tiruchengode,
Namakkal Dt,
Tamilnadu.
Namakkal
TAMIL NADU
637215
India |
| Phone |
9486776806 |
| Fax |
|
| Email |
anitha12121997@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Karthick K |
| Designation |
Professor |
| Affiliation |
KSR Institute of Dental Science and Research,Tiruchengode |
| Address |
Department of Conservative dentistry and Endodontics,
KSR Institute of Dental Science and Research
Tiruchengode-637215.
Namakkal
TAMIL NADU
637215
India |
| Phone |
9843659053 |
| Fax |
|
| Email |
drkarthickendo@ksridsr.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Karthick K |
| Designation |
Professor |
| Affiliation |
KSR Institute of Dental Science and Research,Tiruchengode |
| Address |
Department of Conservative Dentistry and Endodontics,
KSR Institute of Dental Science and Research,
Tiruchengode-637215.
Namakkal
TAMIL NADU
637215
India |
| Phone |
9843659053 |
| Fax |
|
| Email |
drkarthickendo@ksridsr.edu.in |
|
|
Source of Monetary or Material Support
|
| KSR Institute of Dental Science and Research,
Tiruchengode-637215,
Namakkal Dt,
Tamilnadu. |
|
|
Primary Sponsor
|
| Name |
Dr ANITHA T |
| Address |
Department of Conservative Dentistry and Endodontics,
KSR Institute of Dental Science and Research,
Tiruchengode-637215,
Namakkal Dt,
Tamilnadu. |
| 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 |
| DrANITHA T |
KSR Institute of dental science and research |
Department of Conservative Dentistry and Endodontics,
room no :7
Namakkal
TAMIL NADU |
9486776806
anitha12121997@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| KSRIDSR INSTITUTIONAL ETHICS COMMITTEE |
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 |
Pulp capping treatment
|
Group1:Recombinant Platelet Derived Growth Factor-BB
IOPA will be taken after 1 month , 3 months and
after 6 months ,CBCT will be taken,Dentin bridge assessment will be done. |
| Comparator Agent |
Pulp capping treatment |
GROUP 2: MTA
IOPA will be taken after 1 month , 3 months
after 6 months ,CBCT will be taken. Dentin bridge assessment will be done.
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
Class 1 caries in maxillary and mandibular first and second molar with deep caries. Radiographs showing caries approximating pulp will be included. Asymptomatic patients with no tenderness to percussion, positive response to electric pulp testing, and cold test. Normal periodontal status clinically and radiographically will be included. |
|
| ExclusionCriteria |
| Details |
Patients with any Systemic disease will be excluded. History of spontaneous and nocturnal pain. Teeth showing negative response to electric pulp testing and cold test. Teeth with radiographic evidence of pulpal degeneration, resorption, and periapical changes. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
clinical success( no subjective symptoms,no top,mobility,no swelling)
Radiographic success- absence of pulpal and periapical pathologies |
6th month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Presence or absence of dentin bridge formation & volume of formed dentin bridge in cubic mm |
6th month |
|
|
Target Sample Size
|
Total Sample Size="24"
Sample Size from India="24"
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
20/03/2025 |
| 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
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study is mainly planned to compare the efficacy of recombinant platelet derived growth factor as pulp capping agent with MTA in dentin bridge formation |