| CTRI Number |
CTRI/2025/10/096286 [Registered on: 22/10/2025] Trial Registered Prospectively |
| Last Modified On: |
21/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparison of Probiotic, Ozonated Oil, and Conventional Calcium Hydroxide in Protecting Primary Teeth |
|
Scientific Title of Study
|
Comparative Evaluation of Probiotic-Calcium Hydroxide Mix, Ozonated Coconut Oil-calcium hydroxide mix, and Conventional Calcium Hydroxide as a base in Indirect Pulp Capping of Primary Teeth: A Randomized controlled study. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
Other |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
G YUKTA PRAGNYANI |
| Designation |
POST GRADUATE |
| Affiliation |
MNR DENTAL COLLEGE AND HOSPITAL |
| Address |
Room no :08,Department of Pedodontics and Preventive dentistry, MNR Nagar, Fasalwadi,Sangareddy
Medak
TELANGANA
502294
India |
| Phone |
9666220087 |
| Fax |
|
| Email |
yuktayukta9666@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr NASEEMOON SHAIK |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
MNR DENTAL COLLEGE AND HOSPITAL |
| Address |
Room no :08,Department of Pedodontics and Preventive dentistry, MNR Nagar, Fasalwadi,Sangareddy
Medak
TELANGANA
502294
India |
| Phone |
8105935678 |
| Fax |
|
| Email |
dr.naseemoonshaik@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr NASEEMOON SHAIK |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
MNR DENTAL COLLEGE AND HOSPITAL |
| Address |
Room no: 8,Department of Pedodontics and Preventive Dentistry, MNR Dental college and hospital, MNR Nagar, Fasalwadi,Sangareddy
Medak
TELANGANA
502294
India |
| Phone |
8105935678 |
| Fax |
|
| Email |
dr.naseemoonshaik@gmail.com |
|
|
Source of Monetary or Material Support
|
| MNR Dental college and hospital,Room no :08, Department of Pedodontics and Preventive dentistry,MNR Nagar, Fasalwadi, Sangareddy 502294 |
|
|
Primary Sponsor
|
| Name |
MNR DENTAL COLLEGE AND HOSPITAL |
| Address |
Room no :08, Department of Pedodontics and Preventive dentistry, MNR Nagar, Fasalwadi,Sangareddy, telangana 502294 |
| 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 |
| G YUKTA PRAGNYANI |
MNR DENTAL COLLEGE AND HOSPITAL |
Room no :08,Department of Pedodontics and Preventive dentistry,MNR Nagar,
Fasalwadi, Sangareddy, Telangana, 502294
Medak
TELANGANA |
09666220087
yuktayukta9666@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| MNR INSTITUTIONAL ETHICAL COMMITEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
HEALTHY |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Conventional Calcium Hydroxide |
In this group, calcium hydroxide is mixed with saline to obtain a thick consistency suitable for placement. The prepared mix is applied as a protective base and then covered with high strength GIC to achieve complete sealing. The cases are followed up clinically and radiographically at 3 6 9 and 12 months intervals for evaluation of treatment success. |
| Comparator Agent |
Ozonated Coconut Oil–Calcium Hydroxide mix |
In this group, one part of calcium hydroxide powder is mixed with ozonated coconut oil until a firm, moldable, ball like consistency is achieved. This mix is placed as a base over the prepared cavity and covered with high-strength GIC to provide an effective seal. Follow-up evaluations are performed at 3 6 9 and 12 months to assess clinical and radiographic outcomes. |
| Comparator Agent |
Probiotic–Calcium Hydroxide mix |
In this group, a 1:1 mixture of calcium hydroxide and probiotic powder is prepared. Saline is added dropwise to obtain a thick cohesive ball like consistency. The prepared mix is applied as a protective base over the prepared dentin surface followed by coverage with high-strength glass ionomer cement to ensure complete sealing. Clinical and radiographic evaluations are carried out at 3 6 9 and 12 months intervals. |
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
9.00 Year(s) |
| Gender |
Both |
| Details |
Children who are willing to participate in the study and informed consent was obtained from parents.
CLINICAL CRITERIA
Systemically healthy children of age 5-9 yrs with primary molars indicated for indirect pulp capping.
Teeth with deep caries but vital pulp .
RADIOLOGICAL CRITERIA:
No history of swelling sinus tract or abscess.
Intact periodontal ligament space.
No evidence of internal or external root resorption.
No periapical or furcal radiolucency
|
|
| ExclusionCriteria |
| Details |
Children who are not willing to participate in the study.
Teeth with spontaneous pain or signs of irreversible pulpitis.
Presence of swelling sinus tract or abscess.
Teeth with abnormal mobility unrelated to physiological exfoliation.
Systemic conditions affecting wound healing or immunity.
Presence of periapical or furcal radiolucency.
Internal or external resorption detected.
Presence of calcific degeneration or pulp obliteration.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Clinical and radiographic success of indirect pulp capping assessed by absence of pain, swelling, tenderness, mobility, and periapical/furcal radiolucency; evidence of dentin bridge formation. |
At follow-up visits — 3, 6, 9, and 12 months (CBCT at 12-month follow-up). |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Evaluation of dentin bridge formation by assessing pulp vitality using clinical and CBCT assessment. |
At follow-up visits — 3, 6, 9, and 12 months (CBCT at 12-month follow-up). |
|
|
Target Sample Size
|
Total Sample Size="105"
Sample Size from India="105"
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)
|
15/11/2025 |
| 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 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
|
Dental caries is one of the most prevalent oral diseases affecting children and poses a challenge in managing deep carious lesions while maintaining pulp vitality. Indirect Pulp Therapy (IPT) aims to preserve the pulp by removing infected dentin and promoting reparative dentin formation using suitable capping materials.
Calcium hydroxide has been a traditional material for IPT due to its antibacterial and healing properties. However, newer agents such as probiotics and ozonated oils have shown potential benefits. Probiotics help in modulating oral microflora and enhancing tissue healing, while ozonated coconut oil possesses strong antimicrobial and anti-inflammatory actions that can accelerate repair and reduce infection.
This study is designed to compare the clinical and radiographic effectiveness of three materials:
-
Probiotic-Calcium Hydroxide mix
-
Ozonated Coconut Oil-Calcium Hydroxide mix
-
Conventional Calcium Hydroxide
A randomized controlled trial will be conducted on 105 primary molars (5–9 years age group) divided equally into three groups. Clinical and radiographic evaluations will be performed at 3, 6, 9, and 12 months, with CBCT assessment at 12 months to evaluate dentin bridge formation.
The study aims to identify a more effective material for indirect pulp capping that enhances antibacterial activity, promotes dentinogenesis, reduces inflammation, and maintains pulp vitality in primary teeth.
The results may provide valuable insights into improving minimally invasive vital pulp therapy in pediatric dentistry using biologically active materials. |