| CTRI Number |
CTRI/2025/03/083677 [Registered on: 28/03/2025] Trial Registered Prospectively |
| Last Modified On: |
25/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Other |
|
Public Title of Study
|
Comparing Oral Bacteria Around Zinc Oxide-Coated and Uncoated Mini-Implants: A Split-Mouth Study |
|
Scientific Title of Study
|
Comparative evaluation of oral microbiome around zinc oxide nanoparticle coated mini implants a split mouth 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 |
Jerome Thomas |
| Designation |
Post Graduate Resident |
| Affiliation |
Sri Ramachandra Institute of Higher Education and Research |
| Address |
II nd year Postgraduate Department of Orthodontics and Dentofacial Orthopedics, Sri Ramachandra Dental College, Sri Ramachandra Institute of Higher Education and Research, Porur, Chennai
Chennai
TAMIL NADU
600116
India |
| Phone |
7907736321 |
| Fax |
|
| Email |
d0422003@sriher.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sridevi Padmanabhan |
| Designation |
Professor |
| Affiliation |
Sri Ramachandra Institute of Higher Education and Research |
| Address |
Department of Orthodontics and dentofacial orthopedics. Faculty of dental sciences, Sri Ramachandra University, Porur, Chennai, Tamil Nadu, India - 600116
Chennai
TAMIL NADU
600116
India |
| Phone |
9600077428 |
| Fax |
|
| Email |
sridevipadu@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sridevi Padmanabhan |
| Designation |
Professor |
| Affiliation |
Sri Ramachandra Institute of Higher Education and Research |
| Address |
Department of Orthodontics and dentofacial orthopedics. Faculty of dental sciences, Sri Ramachandra University, Porur, Chennai, Tamil Nadu, India - 600116
Chennai
TAMIL NADU
600116
India |
| Phone |
9600077428 |
| Fax |
|
| Email |
sridevipadu@gmail.com |
|
|
Source of Monetary or Material Support
|
| Post Graduate Resident Stipend Sri Ramachandra Institute of Higher Education and Research, Porur, Chennai - 600116 |
|
|
Primary Sponsor
|
| Name |
Post Graduate Resident Stipend |
| Address |
Sri Ramachandra Institute of Higher Education and Research, Porur, Chennai - 600116 |
| 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 |
| Dr Jerome Thomas |
Sri Ramachandra Faculty of Dental Sciences |
Sri Ramachandra Institute of Higher Education and Research, Department of Orthodontics and Dentofacial Orthopedics, room no 9, No.1, Ramachandra Nagar, Porur, Chennai - 600116
Chennai TAMIL NADU
Chennai
TAMIL NADU |
7907736321
d0422003@sriher.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Sri Ramachandra Institute of Higher Education and Research, porur, Chennai |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: 8||Other Procedures, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Uncoated mini implants |
Patients undergoing orthodontic treatment requiring absolute anchorage in the maxillary arch, uncoated mini implants will be placed. Plaque sample will be collected around the nanocoated mini implants and the microbial changes will be evaluated.Total duration of the intervention is 6 months |
| Intervention |
Zinc oxide nanoparticle coated mini implants |
Patients undergoing orthodontic treatment requiring absolute anchorage in the maxillary arch,Zinc oxide nanoparticle coated mini implants will be placed. Plaque sample will be collected around the nanocoated mini implants and the microbial changes will be evaluated.Total duration of the intervention is 6 months |
|
|
Inclusion Criteria
|
| Age From |
14.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients undergoing Orthodontic treatment requiring absolute anchorage in the maxillary arch.
2.Patients with an oral hygiene index of less than or equal to 3
3.patients with no relavant medical history
4.patients with permanent dentition with full compliment of teeth |
|
| ExclusionCriteria |
| Details |
1.patients with poor oral hygiene
2.patients with extensive dental caries
3.patients with no history of illness or allergies
4.patients with periodontitis and bone loss.
5.patients undertaking medications such as antibiotics or anti-inflammatory drugs. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the microbiome around zinc oxide nanocoated orthodontic mini implants and to compare the above with an uncoated orthodontic mini implants |
(T1) 6 months after mini implant placement |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To evaluate the stability of zinc oxide nanoparticle coated mini implants with uncoated mini implants. |
(T1) 6 months after mini implant placement |
|
|
Target Sample Size
|
Total Sample Size="11"
Sample Size from India="11"
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 4 |
|
Date of First Enrollment (India)
|
19/04/2025 |
| 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="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
|
Orthodontic mini implants play an important role in orthodontic treatment as they render absolute skeletal anchorage especially in challenging cases that require high forces such as expansion,distalization,intrusion.Despite high success rate of orthodontic mini implants about a 30 percent of failure rate of mini implants are due to microbial infections and bone inflammation.Generally orthodontic mini implants are additional sites for microorganisms to bind and colonize due to accumulation of dental plaque. Nanoparticle such as silver,copper,gold, or metal oxides such as titanium oxide , copper oxide, zinc oxide have been researched for antibacterial properties.Among these Zinc oxide has attained considerable attention owing to its anti microbial properties, low cost and stability. certain studies have evaluated the anti bacterial efficacy of various nanoparticle coated orthodontic mini implants which are mostly in-vitro studies. There is paucity of in-vivo studies comparing the efficacy of nanoparticle coated orthodontic mini implant.therefore these study was designated to evaluate the changes in microbial colonization around zinc oxide nanoparticle orthodontic mini implants. Patients requiring absolute anchorage and requiring bilateral mini implants will be recruiting for the study.
the following will be group categorization group 1) zinc oxide nanoparticle coated mini implants group 2) uncoated orthodontic mini implants In each group peri mini implants crevicular fluid will be collected using paper points at the end of 6 months to evaluate microbial concentration
|