| CTRI Number |
CTRI/2025/12/099619 [Registered on: 22/12/2025] Trial Registered Prospectively |
| Last Modified On: |
21/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Other |
|
Public Title of Study
|
Comparison of amount of plaque and identification of bacteria in different aligners |
|
Scientific Title of Study
|
A comparative assessment of plaque retention and identification of retentive bacteria in different aligners – a descriptive 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 G Mridula |
| Designation |
Postgraduate |
| Affiliation |
KLE VK Institute of Dental Sciences |
| Address |
Departmnet of Orthodontics and Dentofacial Orthopedics, KLE VK Institute of Dental Sciences,JNMC Campus, Nehrunagar, Belagavi- 590010
Belgaum
KARNATAKA
590010
India |
| Phone |
8050270738 |
| Fax |
|
| Email |
25gmridula@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Trupti Sadhunavar |
| Designation |
Reader |
| Affiliation |
KLE VK Institute of Dental Sciences |
| Address |
Department of Orthodontics and Dentofacial Orthopedics, KLE VK Institute of Dental Sciences,JNMC Campus, Nehrunagar, Belagavi- 590010
Belgaum
KARNATAKA
590010
India |
| Phone |
9449815111 |
| Fax |
|
| Email |
sadhutrup@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr G Mridula |
| Designation |
Postgraduate |
| Affiliation |
KLE VK Institute of Dental Sciences |
| Address |
Department of Orthodontics and Dentofacial Orthopedics, KLE VK Institute of Dental Sciences,JNMC Campus, Nehrunagar, Belagavi- 590010
KARNATAKA
590010
India |
| Phone |
8050270738 |
| Fax |
|
| Email |
25gmridula@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr G Mridula |
| Address |
KLE VK Institute of Dental Sciences, JNMC Campus, Nehru nagar, Belagavi- 590010 |
| 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 G Mridula |
Department of Microbiology, JNMC,Belagavi |
JNMC, Nehrunagar, Belagavi
Belgaum
KARNATAKA |
8050270738
25gmridula@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Research and Ethics Committee, KLE VKIDS |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Patients with malocclusion undergoing clear aligner therapy |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Aligner |
Aligner |
|
|
Inclusion Criteria
|
| Age From |
12.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients undergoing aligner treatment
2.Patients above 12 years of age
3.Patients of either gender
4.Patients with good oral hygiene (with a score of 0-1.2 as per OHI-S)
5.Retention of plaque (as per plaque index)
|
|
| ExclusionCriteria |
| Details |
1.Patients undergoing fixed mechanotherapy
2.Patients with syndromes
3.Patients on medications that cause xerostomia
4.Patients with broken and missing aligners
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Total colony count on aligner surface |
After 14 days of wear |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Identification of the retentive bacteria |
After 14days of wear |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
01/01/2026 |
| 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
|
Aligners were introduced as they are more esthetic as compared to the conventional fixed appliances and they are better in terms of oral hygiene maintenance. However, plaque accumulation is still observed in aligners.This study is being done to assess if plaque retention is more in a certain group of aligners. It is also being done with the intention to identify the retentive bacteria in aligners. |