| CTRI Number |
CTRI/2021/08/035696 [Registered on: 16/08/2021] Trial Registered Prospectively |
| Last Modified On: |
21/11/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Use of chitin-based medicament for the treatment in milk teeth. |
|
Scientific Title of Study
|
Evaluation of chitosan as a pulpotomy agent in primary molars- an in vivo study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Nidhish Krishna R |
| Designation |
Post Graduate Student |
| Affiliation |
A B Shetty Memorial Institute of Dental Sciences |
| Address |
A B Shetty Memorial Institute of Dental Sciences, NITTE Deemed to be University, Deralakatte, Mangalore
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
9566219482 |
| Fax |
|
| Email |
nkris2007@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nikita Lolayekar |
| Designation |
Reader |
| Affiliation |
A B Shetty Memorial Institute of Dental Sciences |
| Address |
A B Shetty Memorial Institute of Dental Sciences, NITTE Deemed to be University, Deralakatte, Mangalore.
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
9886875769 |
| Fax |
|
| Email |
drnikitashanbhag@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Nidhish Krishna R |
| Designation |
Post Graduate Student |
| Affiliation |
A B Shetty Memorial Institute of Dental Sciences |
| Address |
A B Shetty Memorial Institute of Dental Sciences, NITTE Deemed to be University, Deralakatte, Mangalore
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
9566219482 |
| Fax |
|
| Email |
nkris2007@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Nidhish Krishna R |
| Address |
Department of Pediatric and Preventive Dentistry, 4th Floor, A B Shetty Memorial Institute of Dental Sciences, NITTE Deemed to be University, Deralakatte, Mangalore - 575018 |
| Type of Sponsor |
Other [Self support] |
|
|
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 |
| Nidhish Krishna R |
A B Shetty Memorial Institute of Dental Sciences |
Department of Pediatric and Preventive Dentistry, 4th Floor, Room no: 15
Dakshina Kannada
KARNATAKA |
9566219482
nkris2007@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Central Ethical Committee, NITTE University |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K040||Pulpitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Chitosan |
Axiostat which is the commercially available form of Chitosan will be used as a medicament for the pulpotomy procedure. |
| Comparator Agent |
Formocresol |
Formoa-cresol is used as the comparator agent in the control group for the pulpotomy procedure. |
|
|
Inclusion Criteria
|
| Age From |
4.00 Year(s) |
| Age To |
10.00 Year(s) |
| Gender |
Both |
| Details |
1.Large carious lesion in an otherwise restorable primary tooth 2.No spontaneous pain.
3.More than two-thirds of the root length is still present 4.No sign of internal or external root resorption 5.Hemorrhage from the amputated pulp site is controlled within 5 minutes.
|
|
| ExclusionCriteria |
| Details |
1.Not fulfilling the above-mentioned clinical or radiographic criteria.
2.Inability to achieve hemostasis within 5 minutes of pressure application with a moist cotton pellet.
3.Bright red bleeding at the amputated pulp site.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| This study aims to clinically and radiographically evaluate the success of Chitosan as a medicament for pulpotomy. |
6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Chitosan can be used as an alternative to formocresol for pulpotomy procedure. |
6 months |
|
|
Target Sample Size
|
Total Sample Size="46"
Sample Size from India="46"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="46" |
Phase of Trial
Modification(s)
|
Phase 3 |
|
Date of First Enrollment (India)
|
16/08/2021 |
| Date of Study Completion (India) |
21/08/2022 |
| 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
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The literature cites Chitosan’s hemostatic
capability by functioning as a scaffold for clot formation and providing a
strong primary closure at the wound site. Chitosan is said to have
anti-inflammatory properties help in tissue regeneration and the hemostatic
activity is attributed to its positively charged amino functional group causing
an electrostatic interaction with the negatively charged blood cell leading to
clot formation which in turn offers an antibacterial barrier.
Therefore, the goal of this study is to
assess the effectiveness of Chitosan as a pulpotomy medicament both clinically
and radiographically and if successful recommend its use for pulpotomy
procedures in the future. |