| CTRI Number |
CTRI/2024/10/076071 [Registered on: 30/10/2024] Trial Registered Prospectively |
| Last Modified On: |
15/10/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Assessment of clinical and radiological effectiveness of inert collagen sponge saturated by Proanthocyanidin and Polyamidoamine calcium phosphate nanoparticles as a biomaterial on indirect pulp capping compared with MTA in Primary teeth: A Randomized Clinical Trial |
|
Scientific Title of Study
|
Assessment of clinical and radiological effectiveness of inert collagen sponge saturated by Proanthocyanidin and Polyamidoamine calcium phosphate nanoparticles as a biomaterial on indirect pulp capping compared with MTA in Primary teeth: 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 Punit Fulzele |
| Designation |
professor |
| Affiliation |
Sharad Pawar Dental college and Hospital, DMIHER |
| Address |
PG Clinic, Dpartment of pediatric and Preventive Dentistry Sharad Pawar Dental college and Hospital, DMIHER, sawangi, wardha 442107
Wardha
MAHARASHTRA
442107
India |
| Phone |
9890417646 |
| Fax |
|
| Email |
punitr007@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Punit Fulzele |
| Designation |
professor |
| Affiliation |
Sharad Pawar Dental college and Hospital, DMIHER |
| Address |
PG Clinic, Dpartment of pediatric and Preventive Dentistry Sharad Pawar Dental college and Hospital, DMIHER, sawangi, wardha 442107
Wardha
MAHARASHTRA
442107
India |
| Phone |
9890417646 |
| Fax |
|
| Email |
punitr007@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Punit Fulzele |
| Designation |
professor |
| Affiliation |
Sharad Pawar Dental college and Hospital, DMIHER |
| Address |
PG Clinic, Dpartment of pediatric and Preventive Dentistry Sharad Pawar Dental college and Hospital, DMIHER, sawangi, wardha 442107
Wardha
MAHARASHTRA
442107
India |
| Phone |
9890417646 |
| Fax |
|
| Email |
punitr007@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Pediatric and Preventive Dentistry, Sharad Pawar Dental College and hospital, Datta Meghe Institution of Higher education and Research, Sawangi, wardha 442107 |
|
|
Primary Sponsor
|
| Name |
Selfsponsored |
| Address |
Department of Pediatric and Preventive Dentistry, Sharad Pawar Dental College and hospital, Datta Meghe Institution of Higher education and Research, Sawangi, wardha 442107 |
| Type of Sponsor |
Other [self funded ] |
|
|
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 Punit Fulzele |
sharad pawar dental college and hospital |
PG Clinic, Dpartment of pediatric and Preventive Dentistry Sharad Pawar Dental college and Hospital, DMIHER, sawangi, wardha 442107
Wardha
MAHARASHTRA |
9890417646
punitr007@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Datta Meghe Institute of Higher Education and Research 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, (2) ICD-10 Condition: K029||Dental caries, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
MTA as indirect pulp capping biomaterial |
assessment of clinical and radiological effectiveness of MTA compared with nanoparticles as biomaterial on indirect pulp capping in primary teeth
total duration is 1.5 hrs |
| Intervention |
proanthocyanidin with polyamidoamine calcium phosphate nanoparticles as indirect pulp capping biomaterial |
assessment of clinical and radiological effectiveness of inert collagen sponge saturated by proanthocyanidin and polyamidoamine calcium phosphate nanoparticles as biomaterial on indirect pulp capping in primary teeth
total duration is 1.5 hrs |
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
9.00 Year(s) |
| Gender |
Both |
| Details |
1.Teeth with active deep caries on the occlusal or proximal surfaces with a history of dull, reversible pain, or mild discomfort on chewing were included in the study.
2. On radiographic interpretation, caries depth should be greater than two‑third of dentin thickness approaching pulp with no radiolucency in the periapical or furcation area of the teeth are included in the study
|
|
| ExclusionCriteria |
| Details |
1.Patients with systemic diseases
2.uncooperative child
3. Teeth exhibiting signs of irreversible pulpitis such as spontaneous pain, pain on percussion, mobility, sinus tract, abscess, widened periodontal spaces, interrupted lamina dura, pulp involvement, or radiographic evidence of periapical or furcational radiolucency.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The primary outcome of the trial is to assess the clinical success (absence of pain, infection, or symptoms) and radiological success (no radiolucency, root resorption, or abnormal development) of an inert collagen sponge saturated with Proanthocyanidin and Polyamidoamine calcium phosphate nanoparticles compared to MTA for indirect pulp capping in primary teeth. |
baseline,3 months, 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
The secondary outcomes of the trial include evaluating pulp vitality, dentin bridge formation, and the survival rate of treated teeth, along with any inflammatory response and patient-reported outcomes such as discomfort or satisfaction.
|
baseline,3 months, 6 months |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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 1 |
|
Date of First Enrollment (India)
|
01/12/2025 |
| 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="0"
Months="9"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Open to Recruitment |
| 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 - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [chaya.chhabra@gmail.com].
- For how long will this data be available start date provided 01-12-2024 and end date provided 01-10-2025?
Response - Beginning 9 months and ending 36 months following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
this randomized clinical study comparing the clinical and radiological effectiveness of an inert collagen sponge saturated with Proanthocyanidin and Polyamidoamine calcium phosphate nanoparticles versus MTA for indirect pulp capping in primary teeth. The primary aim is to assess the success in terms of symptom relief and radiological outcomes, such as the absence of infection or resorption. Secondary outcomes include pulp vitality, dentin bridge formation, tooth survival rates, inflammatory response, and patient-reported satisfaction. The trial seeks to evaluate the potential of Proanthocyanidin and plyamidoamine calcium phosphate nanoparticle as a biomaterial alternative for preserving pulp health in pediatric dental care. |