| CTRI Number |
CTRI/2025/03/081802 [Registered on: 06/03/2025] Trial Registered Prospectively |
| Last Modified On: |
03/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A comparison of calcium hydroxide and silver diamine fluoride as protective treatments for tooth decay in childrens molars |
|
Scientific Title of Study
|
COMPARATIVE EVALUATION OF CALCIUM HYDROXIDE AND SILVER
DIAMINE FLUORIDE AS INDIRECT PULP CAPPING AGENTS IN PRIMARY
MOLARS -A RANDOMIZED CONTROLLED 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 ATHIRA H |
| Designation |
POSTGRADUATE STUDENT |
| Affiliation |
PMS COLLEGE OF DENTAL SCIENCE AND RESEARCH |
| Address |
DEPARTMENT OF PEDIATRIC AND PREVENTIVE DENTISTRY
PMS COLLEGE OF DENTAL SCIENCE AND RESEARCH ,GOLDEN HILLS ,VATTAPARA ,VENKODE ,TRIVANDRUM
Thiruvananthapuram
KERALA
695028
India |
| Phone |
9400169378 |
| Fax |
|
| Email |
harikrishnan6391@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr SAJEENA GEORGE |
| Designation |
PROFESSOR AND HOD |
| Affiliation |
PMS COLLEGE OF DENTAL SCIENCE AND RESEARCH |
| Address |
PMS COLLEGE OF DENTAL SCIENCE AND RESEARCH ,GOLDEN HILLS ,VENKODE ,VATTAPARA ,TRIVANDRUM
Thiruvananthapuram
KERALA
695028
India |
| Phone |
9400169378 |
| Fax |
|
| Email |
drsajeenajosek@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr ATHIRA H |
| Designation |
POSTGRADUATE STUDENT |
| Affiliation |
PMS COLLEGE OF DENTAL SCIENCE AND RESEARCH |
| Address |
DEPARTMENT OF PEDIATRIC AND PREVENTIVE DENTISTRY
PMS COLLEGE OF DENTAL SCIENCE AND RESEARCH ,GOLDEN HILLS ,VENKODE ,VATTAPARA ,TRIVANDRUM
Thiruvananthapuram
KERALA
695028
India |
| Phone |
9400169378 |
| Fax |
|
| Email |
harikrishnan6391@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr ATHIRA H |
| Address |
East Velliyotillam ,Pulimath po karate ,Trivandrum |
| Type of Sponsor |
Other [funded by myself] |
|
|
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 ATHIRA H |
PMS COLLEGE OF DENTAL SCIENCE AND RESEARCH |
DEPARTMENT OF PEDIATRIC AND PREVENTIVE DENTISTRY
GOLDEN HILLS ,VENKODE ,VATTAPARA ,TRIVANDRUM
Thiruvananthapuram
KERALA |
9400169378
harikrishnan6391@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
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 |
| Comparator Agent |
CALCIUM HYDROXIDE |
considered the gold standard for pulp capping |
| Intervention |
SILVER DIAMINE FLOURIDE |
It is considered a promising treatment for managing caries in a noninvasive manner. |
|
|
Inclusion Criteria
|
| Age From |
4.00 Year(s) |
| Age To |
9.00 Year(s) |
| Gender |
Both |
| Details |
1) Primary molars with deep caries that are closer to a pulp with mild pain during mastication.
2) Primary molars showing positive transient response to thermal and electrical pulp testing
3) Primary molars with radiolucency, involving enamel and dentin with a Remaining Dentin Thickness (RDT) of 0.5-1.5 mm.
|
|
| ExclusionCriteria |
| Details |
Deep caries with a history of spontaneous pain, and night pain.
2) Primary molars, with tenderness on palpation and percussion
3) Abscesses, sinus tract, or gingival inflammation
4) Pathological mobility
5) Radio graphical changes with radiolucencies involving pulp, widening of the periodontal ligament, irregular lamina dura, and periapical radiolucencies
6) Any systemic disease
7) Known allergy to silver
|
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
|
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| clinical and radiographic evaluation |
ASSESSED AFTER 3 MONTHS AND 6 MONTHS |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| no outcomes |
no time points |
|
|
Target Sample Size
|
Total Sample Size="33"
Sample Size from India="33"
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)
|
25/03/2025 |
| 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="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
|
This randomized controlled trial compares calcium hydroxide and silver diamine fluoride (38% and 1:10%) as indirect pulp-capping agents in primary molars. A total of 33 teeth will be randomly assigned to three groups. Procedures include local anesthesia, rubber dam isolation , infected dentin removal, material application, and final restoration with a stainless steel crown. Patients will be reviewed at 3 and 6 months, and clinical and radiographic evaluations will be performed to assess success. Double blinding will be implemented and the outcomes will be based on pain,inflammation,mobility , restoration retention, and radiographic changes |