| CTRI Number |
CTRI/2026/02/104391 [Registered on: 20/02/2026] Trial Registered Prospectively |
| Last Modified On: |
20/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Different Calcium Hydroxide Based Fillings For Treating Baby Teeth - A Clinical and X Ray study |
|
Scientific Title of Study
|
Comparison Of Clinical and Radiographic Outcomes of Calcium Hydroxide Based Obturating Material In Primary Teeth - An In Vivo 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 |
Dr KVasudha |
| Designation |
1st year post graduate |
| Affiliation |
Sibar Institute of Dental Sciences |
| Address |
Room no 7 Room no 7 , department of pediatric and preventive dentistry, Sibar Institute of Dental Sciences ,Takkelapadu
Guntur
ANDHRA PRADESH
522509
India |
| Phone |
8978957621 |
| Fax |
|
| Email |
konkivasudha@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr KVasudha |
| Designation |
1st year post graduate |
| Affiliation |
Sibar Institute of Dental Sciences |
| Address |
Room no 7 , Department of Pediatric and Preventive dentistry, Sibar Institute of Dental Sciences ,Takkelapadu
ANDHRA PRADESH
522509
India |
| Phone |
8978957621 |
| Fax |
|
| Email |
konkivasudha@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr KVasudha |
| Designation |
1st year post graduate |
| Affiliation |
Sibar Institute of Dental Sciences |
| Address |
Room no 7 , Department of Pediatric and Preventive Dentistry, Sibar Institute of Dental Sciences ,Takkelapadu
ANDHRA PRADESH
522509
India |
| Phone |
8978957621 |
| Fax |
|
| Email |
konkivasudha@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sibar institute of dental sciences, Takkellapadu, Guntur, Andhra Pradesh , India 522509 |
|
|
Primary Sponsor
|
| Name |
Dr KVasudha |
| Address |
Room no 7 , Department of Pediatric and Preventive Dentistry, Sibar Institute of Dental Sciences ,Takkelapadu |
| 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 |
| DrKVasudha |
Sibar institute of dental sciences |
Room no 7 , department of pediatric and preventive dentistry, sibar institute of dental sciences ,takkelapadu, Guntur.
Guntur
ANDHRA PRADESH |
8978957621
konkivasudha@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| institutional ethics committee sibar institute of dental sciences |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K040||Pulpitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
1. Calcium hydroxide-iodoform combination |
The sample will be divided into 4 groups with 20 sample in each group and different calcium hydroxide combination will be used as the obturating material with the help of the instrument, ensure that the paste is evenly covering the exposed pulp chamber. |
| Comparator Agent |
1.calcium hydroxide alone |
The sample will be divided into 4 groups with 20 sample in each group and different calcium hydroxide combination will be used as the obturating material with the help of the instrument, ensure that the paste is evenly covering the exposed pulp chamber. |
| Intervention |
2. Calicum hydroxide-propolis combination |
The sample will be divided into 4 groups with 20 sample in each group and different calcium hydroxide combination will be used as the obturating material with the help of the instrument, ensure that the paste is evenly covering the exposed pulp chamber. |
| Intervention |
3. Calcium hydroxide-curcumin combination |
The sample will be divided into 4 groups with 20 sample in each group and different calcium hydroxide combination will be used as the obturating material with the help of the instrument, ensure that the paste is evenly covering the exposed pulp chamber |
|
|
Inclusion Criteria
|
| Age From |
4.00 Year(s) |
| Age To |
8.00 Year(s) |
| Gender |
Both |
| Details |
1.Primary molars with irreversible pulpitis or nonvital pulp.
2.Teeth with adequate root structure.
3.Absence of periapical pathology. |
|
| ExclusionCriteria |
| Details |
1.Teeth with grossly destructed crown structures.
2.Presence of internal or external resorption beyond repairable limits.
3.Non restorable teeth requiring extraction.
4.History of previous endodontic treatment
|
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Clinical outcome – pain Mobility Gingival swelling Sinus opening
Radiological outcome – resorption Radiolucency |
3 month and 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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)
|
11/03/2026 |
| 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
|
Pediatric
dentistry emphasizes the preservation of primary teeth until their natural
exfoliation, and pulpectomy is the treatment of choice for primary teeth with
irreversibly inflamed or necrotic pulp. Zinc oxide eugenol (ZOE), though commonly used, fails
to meet these criteria due to its limited antimicrobial activity and delayed
resorption. Calcium hydroxide, widely used in pediatric endodontics, possesses
a high alkaline pH, sustained ion release, biocompatibility, aiding in halting
internal resorption and neutralizing acidic environments; however, its use as a
sole obturating material is limited by poor sealing ability, high solubility,
inadequate resorption, and restricted antimicrobial efficacy.
To overcome these limitations,
combination pastes have been introduced. Iodoform exhibits strong antibacterial
activity, particularly against anaerobes, resorbs faster, reduces tissue
irritation, and allows easy placement in tortuous canals, while providing
synergistic antimicrobial action when combined with calcium hydroxide. Natural
additives such as curcumin and propolis further enhance the properties of
calcium hydroxide |