| CTRI Number |
CTRI/2025/09/094873 [Registered on: 16/09/2025] Trial Registered Prospectively |
| Last Modified On: |
12/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Preservation of vitality of carious primary tooth using Dilute SDF, MTA AND Chitosan |
|
Scientific Title of Study
|
Clinical and Radiographic Evaluation of Effectiveness of Dilute Silver Diamine Fluoride,Chitosan and Mineral Trioxide Aggregate as Indirect Pulp Capping agents in Primary molars: A Randomized Clinical Trial |
| 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 Kodimela Jyoti Priiya |
| Designation |
PG Student |
| Affiliation |
Hitkarini Dental College and Hospital |
| Address |
2 135 5 choutapalli mattampalli mandal
Choutapalli
Room no 8 Ground floor Department of paediatric and preventive dentistry
Hitkarini dental college and Hospital
Jabalpur
Nalgonda
TELANGANA
508204
India |
| Phone |
06304014382 |
| Fax |
|
| Email |
kodimelajyotipriiya@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Saurabh Tiwari |
| Designation |
Reader |
| Affiliation |
Hitkarini Dental College and Hospital |
| Address |
101 102 matrchaya
Kantiroopam kantivilla
Kajarwara road Bilhari
Room no 8 Ground floor Department of paediatric and preventive dentistry
Hitkarini dental college and Hospital
Jabalpur
Jabalpur
MADHYA PRADESH
482020
India |
| Phone |
7742591007 |
| Fax |
|
| Email |
drsaurabhtiwari297@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Saurabh Tiwari |
| Designation |
Reader |
| Affiliation |
Hitkarini Dental College and Hospital |
| Address |
101 102 matrchaya
Kantiroopam kantivilla
Kajarwara road Bilhari
Room no 8 Ground floor Department of paediatric and preventive dentistry
Hitkarini dental college and Hospital
Jabalpur
Jabalpur
MADHYA PRADESH
482020
India |
| Phone |
7742591007 |
| Fax |
|
| Email |
drsaurabhtiwari297@gmail.com |
|
|
Source of Monetary or Material Support
|
| Hitkarini dental college and hospital |
|
|
Primary Sponsor
|
| Name |
Dr Kodimela Jyoti Priiya |
| Address |
Hitkarini Dental College and Hospital Hitkarini Hills dumna road Jabalpur 482005 |
| 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 Kodimela Jyoti Priiya |
Hitkarini Dental College and Hospital |
Room no 8 Ground floor Department of paediatric and preventive dentistry
Hitkarini dental college and Hospital
Jabalpur
Jabalpur
MADHYA PRADESH |
6304014382
kodimelajyotipriiya@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: 8||Other Procedures, (2) ICD-10 Condition: K029||Dental caries, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Chitosan |
Chitosan mixed with barium sulphate in a ratio 1:1 in distilled water |
| Comparator Agent |
MTA (Angelus) |
MTA mixed with distilled water |
| Intervention |
Silver Diamine Fluoride |
1 drop of SDF mixed in 9 drops of distilled water |
|
|
Inclusion Criteria
|
| Age From |
4.00 Year(s) |
| Age To |
8.00 Year(s) |
| Gender |
Both |
| Details |
1. Primary Molars with intact Periodontium and Lamina dura
2. Patient with asymptomatic carious lesion with distinct dentin involvement, verified by radiographic examination.
3. Carious lesion without any pulpal involvement.
4. Teeth with no radiographic signs of internal and external resorption.
5. No furcation radiolucency.
|
|
| ExclusionCriteria |
| Details |
1.Non-consent of parent to participate in the study.
2.Child with Definitely Negative behavior
3.Teeth with history of spontaneous pain.
4.Deep carious lesion with pulpal involvement.
5.Medically compromised children.
6.Tooth with restoration or fracture.
7.Widened Periodontal Ligament
8.Radiolucency in furcal area.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Formation of teritiary dentin on primary molars |
Baseline, 1 month,3 months,6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Better marginal adaptability and no microleakage |
1 month,3 months,6 months |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
24/09/2025 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
This study compares the effectiveness of Silver diamine fluoride (SDF), Chitosan and Mineral trioxide aggregate (MTA) as Indirect pulp capping agents in primary molars of children of age group 4 years to 8 years. Study is done as randomized clinical trial. |