| CTRI Number |
CTRI/2017/07/009108 [Registered on: 26/07/2017] Trial Registered Retrospectively |
| Last Modified On: |
13/05/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A clinical study to check the effect of two materials for pulp treatment in milk teeth. |
|
Scientific Title of Study
|
Clinical and Radiographic evaluation of Mineral Trioxide Aggregate and Amniotic Membrane pulpotomy in primary molars: A Randomized Clinical Trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ellana Jermiah Joseph |
| Designation |
Post graduate student |
| Affiliation |
Manipal College of Dental Sciences |
| Address |
Manipal College Of Dental Sciences,Department of paedodontics and preventive dentistry, room no.5,
Light House Hill Road, Mangalore - 575001
Dakshina Kannada
KARNATAKA
575001
India |
| Phone |
9833862978 |
| Fax |
|
| Email |
ellana_j@hotmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Arathi Rao |
| Designation |
HOD and Guide |
| Affiliation |
Manipal College of Dental Sciences |
| Address |
Manipal College Of Dental Sciences,Paedontics and preventive Dentistry, room no.5,Light House Hill Road, Mangalore - 575001
Dakshina Kannada
KARNATAKA
575001
India |
| Phone |
9833862978 |
| Fax |
|
| Email |
arathi.rao@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Ellana Jermiah Joseph |
| Designation |
Post graduate student |
| Affiliation |
Manipal College of Dental Sciences |
| Address |
Manipal College Of Dental Sciences,Department of Paedodontics and Prventive Dentistry,Room no 5,
Light House Hill Road, Mangalore - 575001
Dakshina Kannada
KARNATAKA
575001
India |
| Phone |
9833862978 |
| Fax |
|
| Email |
ellana_j@hotmail.com |
|
|
Source of Monetary or Material Support
|
| Manipal College of Dental Sciences,Light House Hill Road, Mangalore - 575001 |
|
|
Primary Sponsor
|
| Name |
NA |
| Address |
NA |
| Type of Sponsor |
Other [NA] |
|
|
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 |
| Ellana Jermiah Joseph |
Manipal College of Dental Sciences |
Light House Hill Road,,Department of Pedodontics and Preventive Dentistry, room no 5. Mangalore - 575001
Dakshina Kannada
KARNATAKA |
9833862978
ellana_j@hotmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee,MCODS Mangalore |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Teeth indicated for pulpotomy, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Amniotic Membrane |
Amniotic membrane will be purchased from TATA memorial hospital,Mumbai |
| Comparator Agent |
Mineral Trioxide Aggregate (MTA) |
MTA (MTA Angelus) |
|
|
Inclusion Criteria
|
| Age From |
4.00 Year(s) |
| Age To |
11.00 Year(s) |
| Gender |
Both |
| Details |
1.Deciduous tooth indicated for pulpotomy
2.Children of parents who have signed the informed Consent form
3.Co-operative and motivated patients |
|
| ExclusionCriteria |
| Details |
1.Tooth with physiologic mobility
2.Uncoperative child |
|
|
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 sucess |
1month, 3months, 6months, 12months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Clinical and Radiographic |
1month, 3months, 6months, 12months |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="20" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
21/12/2016 |
| Date of Study Completion (India) |
13/09/2018 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
none |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The purpose of this study is to compare and evaluate clinical and radiographic outcome of MTA and Amniotic Membrane when used as pulpotomy agents. The objectives are- 1)To evaluate the clinical response following MTA and Amniotic Membrane pulpotomy at 1month, 3months, 6months and 12months. 2)To evaluate the radiographic changes following MTA and Amniotic Membrane pulpotomy at 1month, 3months, 6months and 12months. 3)To compare the clinical response and radiographic changes between MTA and Amniotic Membrane pulpotomy. |