| CTRI Number |
CTRI/2023/11/060218 [Registered on: 23/11/2023] Trial Registered Prospectively |
| Last Modified On: |
26/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A CLINICAL TRIAL TO STUDY TO THE EFFECTS OF MTA PUUTY AND BIOCERAMIC PUTTY IN DECIDUOUS MOLARS OF CHILDREN AGED 4-9 YEARS AS INDIRECT PULP CAPPING AGENTS |
|
Scientific Title of Study
|
“EVALUATION AND COMPARISON OF EFFICACY OF MINERAL TRIOXIDE AGGREGATE (MTA) PUTTY AND
BIOCERAMIC PUTTY AS INDIRECT PULP CAPPING AGENTS IN DECIDUOUS MOLARS – AN IN-VIVO STUDY†|
| 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 PARUL GARG |
| Designation |
MDS IST YEAR |
| Affiliation |
SUDHA RUSTAGI COLLEGE OF DENTAL SCIENCES AND RESEARCH |
| Address |
ROOM NO. 6, DEPARTMENT OF PEDODONTICS, SUDHA RUSTAGI DENTAL COLLEGE, FARIDABAD
Faridabad
HARYANA
121002
India |
| Phone |
9306242526 |
| Fax |
|
| Email |
PARULGARG281998@GMAIL.COM |
|
Details of Contact Person
Scientific Query
|
| Name |
DR NEHA SHEORAN |
| Designation |
PROFESSOR |
| Affiliation |
SUDHA RUSTAGI COLLEGE OF DENTAL SCIENCES AND RESEARCH |
| Address |
ROOM NO. 6, DEPARTMENT OF PEDODONTICS, SUDHA RUSTAGI DENTAL COLLEGE, FARIDABAD
Faridabad
HARYANA
121002
India |
| Phone |
9306242526 |
| Fax |
|
| Email |
SHEORAN.NEHA@YAHOO.CO.IN |
|
Details of Contact Person
Public Query
|
| Name |
DR PARUL GARG |
| Designation |
MDS IST YEAR |
| Affiliation |
SUDHA RUSTAGI COLLEGE OF DENTAL SCIENCES AND RESEARCH |
| Address |
ROOM NO. 6, DEPARTMENT OF PEDODONTICS, SUDHA RUSTAGI DENTAL COLLEGE, FARIDABAD
Faridabad
HARYANA
121002
India |
| Phone |
9306242526 |
| Fax |
|
| Email |
PARULGARG281998@GMAIL.COM |
|
|
Source of Monetary or Material Support
|
| SUDHA RUSTAGI COLLEGE OF DENTAL SCIENCES AND RESEARCH, FARIDABAD, HARYANA, 121002 |
|
|
Primary Sponsor
|
| Name |
DR PARUL GARG |
| Address |
WARD NO. 3, PECH COLONY, OPPOSITE AGGARWAL DHARAMSHALA, HODAL, PALWAL |
| Type of Sponsor |
Other [SELF] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| DR PARUL GARG |
C-1/10, SECTOR 85, FARIDABAD |
| NIL |
NIL |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DR PARUL GARG |
SUDHA RUSTAGI DENTAL COLLEGE |
SUDHA RUSTAGI COLLEGE OF DENTAL SCIENCES AND RESEARCH, FARIDABAD
Faridabad
HARYANA |
9306242526
parulgarg281998@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SRCDSR-IEC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
presence of dental caries |
| Patients |
(1) ICD-10 Condition: K029||Dental caries, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
BIOCERAMIC PUTTY |
A NEW MATERIAL FOR IPC, THE INTERVENTION WILL TAKE ABOUT 9 MONTHS FOLLOW UP |
| Comparator Agent |
MTA PUTTY |
GOLD STANDARD, 9 MONTHS FOLLOW UP IS REQUIRED |
|
|
Inclusion Criteria
|
| Age From |
4.00 Year(s) |
| Age To |
9.00 Year(s) |
| Gender |
Both |
| Details |
It will be comprised of subjects willing to participate in the study.
ï‚· Deciduous molars with occlusal lesion, removal of which likely to expose the
pulp.
ï‚· Mild discomfort from chemical and thermal stimuli.
ï‚· Dentinal lesions involving only 3/4th of dentin thickness with no pulp
involvement (confirmed by radiograph)
|
|
| ExclusionCriteria |
| Details |
The medically compromised patients and patients on antibiotics within three
months will be excluded from the study.
ï‚· Presence of signs such as prolonged or spontaneous pain, pathological
mobility, sensitivity to percussion.
ï‚· Presence of infectious symptoms like abscess, sinus or fistula and
discoloration of tooth |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| clinical & radiographic efficacy of bioceramic putty & MTA putty at baseline, 3 months, 6 months and 9 months |
clinical & radiographic efficacy of bioceramic putty & MTA putty at baseline, 3 months, 6 months, and 9 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| amount of dentin thickness |
dentin thickness after application of material at baseline, 3 months, 6 months and 9 months |
|
|
Target Sample Size
|
Total Sample Size="82"
Sample Size from India="82"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="82" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
02/12/2023 |
| Date of Study Completion (India) |
19/12/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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 aims to evaluate and compare the clinical and radiographic efficacy of MTA putty and Bioceramic putty as IPC agents in deciduous molars. this study describe whether bioceramic putty or mta putty can achive good results as only calcium hydroxide has been used till now. |