| CTRI Number |
CTRI/2025/07/091593 [Registered on: 24/07/2025] Trial Registered Prospectively |
| Last Modified On: |
23/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Study evaluating the antimicorbial effect of Zinc Oxide (ZnO) Nanoparticle coated mini implant |
|
Scientific Title of Study
|
Comparative Assessment of Antimicrobial Effect of Zinc Oxide (ZnO) Nanoparticle Coated Titanium Mini Implants: A Split Mouth Randomized Controlled 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 Madhulika Singh |
| Designation |
Post graduate student |
| Affiliation |
MGM Dental College and Hospital Kamothe Navi Mumbai |
| Address |
Room no - 36, 6th floor, Department of Orthodontics,MGM Dental College and Hopital, Kamothe,Navi Mumbai
Mumbai (Suburban)
MAHARASHTRA
410209
India |
| Phone |
7058809595 |
| Fax |
|
| Email |
madhulikasingh600@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Anjali Gheware |
| Designation |
Professor |
| Affiliation |
MGM Dental College and Hospital Kamothe Navi Mumbai |
| Address |
Room no-36, 6th floor, Department of Orthodontics,MGM Dental College and Hospital, Kamothe
Mumbai (Suburban)
MAHARASHTRA
410209
India |
| Phone |
9619603566 |
| Fax |
|
| Email |
anjaligheware@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Madhulika Singh |
| Designation |
Post graduate student |
| Affiliation |
MGM Dental College and Hospital Kamothe Navi Mumbai |
| Address |
Room no-36,6th Floor, Department of Orthodontics, MGM Dental college and Hospital, Kamothe, Navi Mumbai
Mumbai (Suburban)
MAHARASHTRA
410209
India |
| Phone |
7058809595 |
| Fax |
|
| Email |
madhulikasingh600@gmail.com |
|
|
Source of Monetary or Material Support
|
| MGM Dental College and Hospital,Kamothe, Navi Mumbai- 410209 |
|
|
Primary Sponsor
|
| Name |
MGM Dental College and Hopsital, Navi Mumbai |
| Address |
MGM DENTAL COLLEGE AND HOSPITAL, KAMOTHE Junction of NH4 and Sion-Panvel express, Sector 18, Navi Mumbai, Maharashtra 410209 Raigarh MAHARASHTRA 410209 India |
| Type of Sponsor |
Private hospital/clinic |
|
|
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 Madhulika Singh |
MGM Dental College and Hospital, Kamothe |
Room no-36, 6th floor, Department of Othodontics
Raigarh
MAHARASHTRA |
7058809595
madhulikasing600@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics committee, MGM Dental College and Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K088||Other specified disorders of teethand supporting structures, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
uncoated titanium mini implant |
uncoated titanium mini implant will simultanoeusly be placed on the other side of the maxillary arch in premolar region and swab will be collected to check for the micorbial count on the day of implant insertion and will be repeated again after 4 weeks |
| Intervention |
ZnO nanoparticle coated Titanium mini implant |
Zinc oxide nanoparticle coating will be done on Titanium mini implants and it will be inserted between premolar region in maxillary arch and swabs will be collected to check for the micorbial count in the region of coated mini implant on the day of implant placement and again after 4 weeks of implant placement. Total intervention duration is 4 weeks |
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Both |
| Details |
1.Patient requiring mini implants placement in their course of orthodontic treatment
2. Site of mini implant placement Buccal placement in Maxillary arch between second
premolar and first molar
3. Self drilling type of Titanium Mini implants coated with ZnO nanoparticles
4. Age 16 to 35 years
5. Size Brand Design matched Vector TAS ORMCO1.4×8 mm size |
|
| ExclusionCriteria |
| Details |
1. Any other medical coating other than ZnO
2. Patients with systemic disease
3. Patients taking any antibiotics upto 3 month prior to mini implant placement
4. Patients taking any antibiotics and corticosteroids during the course of study
5. Patients with habit of smoking and alcohol consumption
6. Pregnant females
7. Periodontally compromised patients
8. Mini implants other than Vector TAS, ORMCO and size 1.4×8 mm |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Primary outcome is to evaluate the antimicorobial effectiveness of ZnO nanoparticle coated titanium mini implant |
Outcome will be assessed before insertion baseline and after 4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| retention of zinc oxide nanoparticle coating will be evaluated |
after 4 weeks |
|
|
Target Sample Size
|
Total Sample Size="15"
Sample Size from India="15"
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)
|
15/08/2025 |
| 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="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
|
The Study is a Split Mouth Randomized Controlled Study. Zno Nanoparticle has been used in dentistry in various fields such as Endodontics, Prosthodontics because of its antimicrobial activity. Recently ZnO nanoparticls have been introduced in Orthodontics for coating on orthodontic mini implants. In vitro studies have shown the antimicrobial activity of ZnO Nanoparticle. This study intends to evaluate the clinical efficiency of ZnO nanoparticle coated mini implants against the oral pathogen contributing in mini implant failure. For this study, patients coming to department of orthodontics will be selected as per Convenient, Consecutive, Consenting sampling for their participation in the study. A sample size of 15 patients will be taken (n=15). Two groups will be taken in each patient: Group A (ZnO coated Mini Implant) and Group B ( Uncoated mini implant). SEM and EDS tests will be done prior to placing
the mini implant in patients to check the surface characteristics of mini implant. Allocation of mini implants in patient’s mouth either on left or right side will be based on block randomization technique. Swab will be taken on both sides at implant and gingival interface before and after 1 month of insertion. The antimicrobial activity against oral pathogens- 1.Streptococcus mutans 2.Staphylococcus
aureus 3. Enterobacter aeruginosa will be checked by counting the colony forming unit per ml
for zinc oxide coated and uncoated mini implants sample at baseline (T0) and 4 weeks (T1)
intervals
. Results will be obtained in the form CFU/ml in tables |