| CTRI Number |
CTRI/2024/02/063229 [Registered on: 28/02/2024] Trial Registered Prospectively |
| Last Modified On: |
22/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Pulp protecting agents for primary teeth |
|
Scientific Title of Study
|
A comparative assessment of clinical efficacy of various types of pulp capping agents in primary teeth- A prospective randomized clinical 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 |
Siddhi Kamble |
| Designation |
Post-Graduation Student |
| Affiliation |
M.A. Rangoonwala College of Dental Science and Research Center |
| Address |
406 Second floor
M A Rangoonwala College of Dental Science and Research Centre,Azam Campus 2390B, K.B, Hidayatulla Rd, Camp,Pune
Pune
MAHARASHTRA
411001
India |
| Phone |
7447431733 |
| Fax |
|
| Email |
siddhik8599@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Abhinav L. Talekar |
| Designation |
Post-Graduation Guide |
| Affiliation |
M.A. Rangoonwala College of Dental Science and Research Center |
| Address |
406 Second floor
M A Rangoonwala College of Dental Science and Research Centre,Azam Campus 2390B, K.B, Hidayatulla Rd, Camp,Pune
Pune
MAHARASHTRA
411001
India |
| Phone |
9503079151 |
| Fax |
|
| Email |
drabhinavtalekar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Siddhi Kamble |
| Designation |
Post-Graduation Student |
| Affiliation |
M.A. Rangoonwala College of Dental Science and Research Center |
| Address |
406 Second floor
M A Rangoonwala College of Dental Science and Research Centre,Azam Campus 2390B, K.B, Hidayatulla Rd, Camp,Pune
Pune
MAHARASHTRA
411001
India |
| Phone |
7447431733 |
| Fax |
|
| Email |
siddhik8599@gmail.com |
|
|
Source of Monetary or Material Support
|
| M A Rangoonwala College Of Dental Science & Research Centre,Azam Campus 2390B, K.B, Hidayatulla Rd, Camp, Pune, Maharashtra 411001 |
|
|
Primary Sponsor
|
| Name |
Siddhi Kamble |
| Address |
406 Second floor
M A Rangoonwala College of Dental Science and Research Centre,Azam Campus 2390B, K.B, Hidayatulla Rd, Camp,Pune |
| 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 Siddhi Kamble |
M A Rangoonwala College Of Dental Science & Research Centre |
406 Second floor
M A Rangoonwala College of Dental Science and Research Centre,Azam Campus 2390B, K.B, Hidayatulla Rd, Camp,Pune
Pune
MAHARASHTRA |
7447431733
siddhik8599@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethical Committe M.C.E. Society. |
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 |
Biodentine,Septodont(France) |
The material will be lined over the pulp chamber post caries excavation and will be covered with Glass ionomer cement and composite. |
| Intervention |
MTA Repair HP,Angelus(Londrina-PR,Brazil ) |
The material will be lined over the pulp chamber post caries excavation and will be covered with Glass ionomer cement and composite. |
| Comparator Agent |
NeoLINER LC,NuSmile(Texas,U.S.A) |
The material will be lined over the pulp chamber post caries excavation and will be covered with Glass ionomer cement and composite. |
| Comparator Agent |
NEOPUTTY,NuSmile(Texas,U.S.A) |
The material will be lined over the pulp chamber post caries excavation and will be covered with Glass ionomer cement and composite |
| Comparator Agent |
Theracal LC,Bisco,(Illinois, U.S.A.) |
The material will be lined over the pulp chamber post caries excavation and will be covered with Glass ionomer cement and composite |
|
|
Inclusion Criteria
|
| Age From |
3.00 Year(s) |
| Age To |
9.00 Year(s) |
| Gender |
Both |
| Details |
Children between 3 and 9 years
no history of spontaneous pain
International Caries Detection and Assessment System (ICDAS) 5+ criteria. |
|
| ExclusionCriteria |
| Details |
presence of
interradicula,periapical pathology
sinus,fistula, internal resorption
pathologic mobility
parents not willing to be part of study. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To assess the dentin bridge formation after the use of various types of pulp capping
agents in primary teeth. The dentin bridge formation will be assessed radiographically |
1 week, 3 months and 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
The presence of post operative pain, swelling will be evaluated after the application of various types of pulp capping
agents in primary teeth. These will be clinically evluated . |
1 week, 3 months & 6 months |
|
|
Target Sample Size
|
Total Sample Size="75"
Sample Size from India="75"
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
|
N/A |
|
Date of First Enrollment (India)
|
29/03/2024 |
| 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="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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 is a prospective randomized clinical study. 75 Teeth will be divided into four groups. Group A – Biodentin Group B – Neo MTA Group C- MTA- HP Group D – Theracal Group E - Neo Liner CLINICAL PROCEDURE -administration of local anesthesia. -Isolation of teeth using rubber dam. -Cavity preparation using diamond burs (330 SS white) at high speed with water coolant. -caries removal with a spoon excavator according to principles of minimally invasive dentistry (All of the caries will be excavated from cavity walls to ensure adequate bonding. The infected dentin will be excavated leaving behind a thin layer of affected dentin when the pulp is approximated. removal of all infected dentin is ensured for which Cavity disinfectant is used. -Then various Indirect pulp capping materials such as Biodentine, Neo MTA, MTA- HP, Theracal, Neo Liner will be placed in cavity according to the manufacturer’s instructions. -Followed by final restorative material. FOLLOW UP Follow up of the restorations will be set at 1 week, 3 months and 6 months. |