| CTRI Number |
CTRI/2024/06/069096 [Registered on: 18/06/2024] Trial Registered Prospectively |
| Last Modified On: |
14/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of two Indian based chemical agents for caries removal |
|
Scientific Title of Study
|
Comparative evaluation of clinical effectiveness of
two indigenous papain based chemomechanical caries
removal agents – A randomized controlled trial |
| Trial Acronym |
CMCR- Chemo mechanical caries removal
RCT- randomized controlled trial |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Lakshmi Priya |
| Designation |
II Year Post graduate |
| Affiliation |
Meenakshi Ammal Dental College and Hospital |
| Address |
Room No -4, Second floor
Department of Public Health Dentistry
Meenakshi Ammal Dental College and Hospital, Chennai
Chennai
TAMIL NADU
600095
India |
| Phone |
9566072388 |
| Fax |
|
| Email |
lakshmipriyasrinivasan97@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shyam Sivasamy |
| Designation |
Professor |
| Affiliation |
Meenakshi Ammal Dental College and Hospital, |
| Address |
ROOM NO-4, SECOND FLOOR
DEPARTMENT OF PUBLIC HEALTH DENTISTRY,
Meenakshi Ammal Dental College and Hospital, Chennai
Chennai
TAMIL NADU
600095
India |
| Phone |
9884542249 |
| Fax |
|
| Email |
shyamsivyog@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shyam Sivasamy |
| Designation |
PROFESSOR |
| Affiliation |
Meenakshi Ammal Dental College and Hospital |
| Address |
Room No -4 , Second Floor, Department of Public Health Dentistry,,
Meenakshi Ammal Dental College and Hospital, Chennai
Chennai
TAMIL NADU
600095
India |
| Phone |
9884542249 |
| Fax |
|
| Email |
shyamsivyog@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Shyam Sivasamy |
| Address |
Meenakshi Ammal Dental College and Hospital,
Alapakkam main road ,
Maduravoyal, Chennai |
| 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 |
| Dr Lakshimipriya |
Meenakshi Ammal Dental College and Hospital |
Room No -4, Second floor,
Department of Public Health Dentistry,
Meenakshi Ammal Dental College and Hospital, Chennai
Chennai
TAMIL NADU |
9566072388
lakshmipriyasrinivasan97@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee of Meenakshi Ammal Dental College& Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
APPARENTLY HEALTHY HUMAN SUBJECTS WITH NO CONGENITAL OR SYSTEMIC ILLNESS HAVING DENTAL CARIES ON POSTERIOR TEETH WITH NO PULPAL INVOLVEMENT |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Indigenous papain based CMCR agent (Cariefix) |
The carious tooth selected will be treated with Cariefix and will be left for 1 minute then excess will be removed with a cotton piece and will be restored using GIC and the total duration of the procedure will be around 10 minutes |
| Intervention |
Indigenous papain based CMCR agent (V-CarieSolv)
|
The carious tooth selected will be treated with V-CarieSolv and will be left for 1 minute then excess will be removed with a cotton piece and will be restored using GIC
and the total duration of the procedure will be around 10 minutes |
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
9.00 Year(s) |
| Gender |
Both |
| Details |
Children with bilateral carious lesions not
extending beyond the inner one third of dentin in
radiograph
Children of parents who give consent for
participation in the study
Children who give assent |
|
| ExclusionCriteria |
| Details |
Children who have multiple deep caries lesions
which require pulp therapy or treatment under
general anesthesia
Children with special needs
|
|
|
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 Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To compare the clinical effectiveness of two indigenous
papain based chemomechanical caries removal agents
among Children |
baseline , 3 months, 6 months,9 months and 12 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Survival rates of restorative material placed after caries removal
Incidence of secondary caries |
3,6,9,12 months |
|
|
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)
|
17/07/2024 |
| 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
|
Patients of the required eligibility criteria will be selected and participants will be randomized and will be grouped into intervention and control groups and the outcomes will be assessed at the end of 3,6,9 and 12 months |