| CTRI Number |
CTRI/2025/03/082145 [Registered on: 11/03/2025] Trial Registered Prospectively |
| Last Modified On: |
28/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparative Evaluation of Nanohydroxyapatite & EGCG mix versus Biodentine for Indirect Pulp Therapy in Young Permanent Teeth |
|
Scientific Title of Study
|
Comparative Evaluation Of Indirect Pulp Therapy In Young Permanent Teeth Using Nanohydroxyapatite And Epigallocatechin-3-Gallate (EGCG) Mix Versus Biodentine: 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 Etisha Sharma |
| Designation |
Post Graduate Student |
| Affiliation |
ITS Dental College, Hospital and Research Centre |
| Address |
Room number 9, Department of Paediatric and Preventive Dentistry, ITS Dental College, Hospital and Research Centre, 47, Knowledge Park-III Greater Noida
Gautam Buddha Nagar
UTTAR PRADESH
201310
India |
| Phone |
8447241594 |
| Fax |
|
| Email |
etisha2010@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mousumi Goswami |
| Designation |
Prof and Head Department of Paediatric and Preventive Dentistry |
| Affiliation |
ITS Dental College, Hospital and Research Centre |
| Address |
ITS Dental College, Hospital and Research Centre, 47, Knowledge Park-III Greater Noida
Gautam Buddha Nagar
UTTAR PRADESH
201310
India |
| Phone |
8588854190 |
| Fax |
|
| Email |
mousumi87goswami@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mousumi Goswami |
| Designation |
Prof and Head Department of Paediatric and Preventive Dentistry |
| Affiliation |
ITS Dental College, Hospital and Research Centre |
| Address |
ITS Dental College, Hospital and Research Centre, 47, Knowledge Park-III Greater Noida
UTTAR PRADESH
201310
India |
| Phone |
8588854190 |
| Fax |
|
| Email |
mousumi87goswami@gmail.com |
|
|
Source of Monetary or Material Support
|
| ITS Dental College, Hospital and Research Centre, 47 Knowledge park III, Greater Noida, India, 201310 |
|
|
Primary Sponsor
|
| Name |
ITS Dental College, Hospital and Research Centre |
| Address |
Room number 9, Department of Paediatric and Preventive Dentistry, ITS Dental College, Hospital and Research Centre, 47, Knowledge Park-III Greater Noida-201310, Uttar Pradesh |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Etisha Sharma |
ITS Dental College, Hospital and Research Centre |
Room number 9, Department of Paediatric and Preventive Dentistry, ITS Dental College, Hospital and Research Centre, 47, Knowledge Park-III Greater Noida
Gautam Buddha Nagar
UTTAR PRADESH |
8447241594
etisha2010@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| I.T.S Dental College, Hospital and Research Centre 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 |
Biodentine |
as an Indirect Pulp Therapy agent |
| Intervention |
Nanohydroxyapatite And Epigallocatechin-3-Gallate (EGCG) Mix |
as an Indirect Pulp Therapy Agent for 6 months |
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
15.00 Year(s) |
| Gender |
Both |
| Details |
1- Age Group- 6 to 15 years
2- Clinical: Young permanent posterior teeth with deep dentinal caries (ICDAS 5 & 6).
3- Radiographic: Teeth with carious lesion and open apices with no radiographic evidence of involvement of pulp.
|
|
| ExclusionCriteria |
| Details |
1- Children with systemic disease and special healthcare needs.
2- Clinical: History of spontaneous pain and swelling, presence of abscess, pain with percussion, pathologic mobility.
3- Radiographic: Carious lesion involving pulp, periapical radiolucency, interrupted lamina dura, thickening of PDL space, internal/external root resorption and presence of pulp calcification. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Post Operative Pain +/-, Tenderness on Percussion +/-, Abscess +/- |
At Baseline, 1 Month, 3 Months, 6 Months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Continued root development, PDL widening, Periapial pathology |
at baseline, 1 month, 3 months, 6 months |
|
|
Target Sample Size
|
Total Sample Size="44"
Sample Size from India="44"
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 |
|
Date of First Enrollment (India)
|
27/04/2025 |
| 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
|
Indirect Pulp Therapy (IPT) is a conservative treatment approach that preserves the vitality of pulp and promotes continued root development in young permanent teeth. Biodentine, a tricalcium silicate-based material, is currently the gold standard for IPT due to its biocompatibility, anti-inflammatory properties, and ability to induce dentin formation. However, there is growing interest in natural alternatives that enhance tissue healing and remineralization. Nanohydroxyapatite (nanoHA) closely resembles dentin’s natural composition, promoting calcium and phosphate deposition, while Epigallocatechin-3-gallate (EGCG), a green tea polyphenol, provides antioxidant, antibacterial, and anti-inflammatory benefits. The combination of nanoHA and EGCG offers a novel approach for pulp healing and dentin regeneration by reducing bacterial activity, preserving dentin bond strength, and minimizing nanoleakage. This study aims to evaluate the in vivo effectiveness of the nanoHA and EGCG mix as an IPT agent in young permanent teeth and compare its performance with Biodentine, the current superior bioactive material. |