| CTRI Number |
CTRI/2024/06/068620 [Registered on: 10/06/2024] Trial Registered Prospectively |
| Last Modified On: |
07/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Clinical evaluation of zinc oxide nanoparticles - containing cavity cleaning agent used in molar milk teeth of children. |
|
Scientific Title of Study
|
Clinical evaluation of the effectiveness of Zinc Oxide nanoparticles-containing cavity disinfectant on the retention of restorations in carious primary molars |
| 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. Abhinaya Ananthakumar |
| Designation |
First year post graduate student |
| Affiliation |
JSS Dental College and Hospital |
| Address |
Room no 5, Department of Pediatric and Preventive Dentistry, JSS Dental College and Hospital, JSSAHER, Bannimantap, Mysuru , Karnataka
Mysore KARNATAKA 570015 India |
| Phone |
8903402142 |
| Fax |
|
| Email |
abhinaya17.ananth@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
DR Seema Deshmukh |
| Designation |
Reader |
| Affiliation |
JSS Dental College and Hospital |
| Address |
Room no 05, Department of Pediatric And Preventive Dentistry, JSS Dental College and Hospital, Bannimantap, Mysuru, Karnataka 570015
Mysore KARNATAKA 570015 India |
| Phone |
|
| Fax |
|
| Email |
seema.pedo@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr. Abhinaya Ananthakumar |
| Designation |
First year post graduate student |
| Affiliation |
JSS Dental College and Hospital |
| Address |
Room no 5, Department of Pediatric and Preventive Dentistry, JSS Dental College and Hospital, Bannimantap, Mysuru, Karnataka 570015
Mysore KARNATAKA 570015 India |
| Phone |
8903402142 |
| Fax |
|
| Email |
abhinaya17.ananth@gmail.com |
|
|
Source of Monetary or Material Support
|
| JSS Dental College and Hospital, Bannimantap, Mysuru, Karnataka 570015 |
|
|
Primary Sponsor
|
| Name |
JSS Dental College and Hospital |
| Address |
Mysuru, Karnataka, India 570015 |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Abhinaya Ananthakumar |
JSS Dental College and Hospital, Mysuru, Karnataka 570015 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Abhinaya Ananthakumar |
JSS Dental College and Hospital |
Room no 5, Department of Pediatric and Preventive Dentistry, JSS Dental College and Hospital, Bannimantap Mysore KARNATAKA |
8903402142
abhinaya17.ananth@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| JSS DENTAL COLLEGE AND HOSPITAL INSTITUTIONAL COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K025||Dental caries on pit and fissure surface, (2) ICD-10 Condition: A488||Other specified bacterial diseases, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Chlorexidine gel |
positive control
used as cavity disinfectant topical application of the solution onto the floor of the cavity for 60 seconds and will be washed and dried. |
| Comparator Agent |
saline |
negative control
used as cavity disinfectant topical application of the solution onto the floor of the cavity for 60 seconds and will be washed and dried. |
| Intervention |
Zinc oxide Nanoparticles |
Cavity disinfectant topical application of the solution onto the floor of the cavity for 60 seconds and will be washed and dried. |
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
9.00 Year(s) |
| Gender |
Both |
| Details |
Children included-
1.within age of 6-9 years with presence of caries in any primary 1st and 2nd molar
2. moderately deep cavities (ICDAS II caries score 4,5,6) limited to single-surface occlusal lesions
3.systemically healthy and cooperative children (Frankl scale 3 and 4)
Radiographic criteria:
1.Children with caries involving enamel, dentin and with at least remaining dentin thickness of at least 0.5mm
|
|
| ExclusionCriteria |
| Details |
Children with-
1.intellectual disability
2.systemic illness and on long term medication
3.presence of root stumps in oral cavity
4.presence of open carious lesions in oral cavity
5.with any known allergy
6.buccal/lingual extension
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To evaluate and compare the effect of zinc oxide nanoparticles containing cavity disinfectant with that of commercially available chlorhexidine gel on retention of the restorations using FDI clinical scoring criteria
|
assessed at baseline, 3 months, and 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.To evaluate & compare the antimicrobial activity of zinc oxide nanoparticles with that of commercially available chlorhexidine gel as a cavity disinfectant in the prepared cavity by using microbial plating.
2.To evaluate & compare the ultrastructure of dentin tubules after disinfection with a zinc oxide-incorporated disinfectant & chlorhexidine on sectioned teeth through scanning electron microscopy (in vitro).
|
at baseline, 3 months, 6 months |
|
|
Target Sample Size
|
Total Sample Size="96" Sample Size from India="96"
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 3/ Phase 4 |
|
Date of First Enrollment (India)
|
20/06/2024 |
| 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="7" 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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol Response - Clinical Study Report
- Who will be able to view these files?
Response - Anyone
- 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 [abhinaya17.ananth@gmail.com].
- For how long will this data be available start date provided 11-06-2024 and end date provided 30-03-2026?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Dental caries is a common oral health problem in children characterized
by the destruction of tooth structures at various levels. With the advent of
minimally invasive techniques, bacteria in the affected carious tissue are
still left behind after removing infected tissue. Microgaps around
the restorations can form at margins due to polymerization shrinkage and
chewing pressures. This could promote bacterial growth, particularly
S. mutans, under the restoration, causing secondary caries and reducing longevity
of the restoration. Thus, to overcome this, the concept of cavity disinfectants
was introduced. Disinfecting the cavity after caries removal helps prevent
recurrent caries, post-procedure sensitivity, and restoration failure. Several
studies have reported using chlorhexidine, sodium hypochlorite, and silver,
zinc, and titanium nanoparticles as cavity disinfectants. Nanoparticles are
small size particles ranging from 1 to 100 nm. They exhibit efficient
antibacterial properties, protect adhesives from degradation, prevent caries,
inhibit biofilm formation and maturation, and promote remineralization. Among
various metals that are being modified and incorporated in combination with
oxide, zinc is known for its biocompatibility antibacterial effects. According
to US-FDA, zinc oxide is considered as generally recognized as safe (GRAS) substance. Zinc oxide nanoparticles (ZnONPs) are chosen for their minimal
cytotoxicity in human cells and as antibacterial even at low concentrations. In
vitro studies confirm that ZnO NP cavity disinfectants outperform alternatives
in antibacterial efficacy without compromising restoration bonding strength. The purpose of the study is to evaluate the efficacy of the zinc oxide nanoparticles - containing cavity disinfectant as an alternative to commercially available ones, with effective antimicrobial activity and unpertubed retention of the restorations placed over the cavity. |