| CTRI Number |
CTRI/2025/07/090570 [Registered on: 09/07/2025] Trial Registered Prospectively |
| Last Modified On: |
08/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
COMPARITIVE EVALUATION OF MICROBILOGICALPROPERTIES OF
BEGGS RETAINERS V/S 3D PRINTED RETAINERS
|
|
Scientific Title of Study
|
COMPARATIVE MICROBIOLOGICAL
EVALUATION OF BIOFILM ON
BEGG’S RETAINERS V/S 3D PRINTED
RETAINERS:
AN IN VIVO 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 |
Ishu Dangi |
| Designation |
PG student (orthodontics) |
| Affiliation |
Sudha Rustagi College of Dental Sciences and Research |
| Address |
Department of Orthodontics and Dentofacial Orthopaedics
Sudha Rustagi College of Dental Sciences and Research sector 89 Faridabad
HARYANA
121002
India
Faridabad
HARYANA
121002
India |
| Phone |
7027058532 |
| Fax |
|
| Email |
dangi.ishu29@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Gurkeerat Singh |
| Designation |
Professor and head of department (orthodontics) |
| Affiliation |
Sudha Rustagi College of Dental Sciences and Research |
| Address |
ROOM NO 4, DEPARTMENT OF ORTHODONTICS, Sudha Rustagi College of Dental Sciences and Research sector 89 Faridabad
HARYANA
121002
India
Faridabad
HARYANA
121002
India |
| Phone |
9811063930 |
| Fax |
|
| Email |
drgurkeeratsingh@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Ishu Dangi |
| Designation |
PG Student (orthodontics) |
| Affiliation |
Sudha Rustagi College of Dental Sciences and Research |
| Address |
ROOM NO 4, DEPARTMENT OF ORTHODONTICS, Sudha Rustagi College of Dental Sciences and Research sector 89 Faridabad
HARYANA
121002
India
Faridabad
HARYANA
121002
India |
| Phone |
07027058532 |
| Fax |
|
| Email |
dangi.ishu29@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Ishu Dangi |
| Address |
Sudha Rustagi College of Dental Sciences and Research sector 89 Faridabad
HARYANA
121002
India |
| 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 |
| Ishu Dangi |
Sudha rustagi college of dental sciences and research, faridabad |
department of orthodontics room number 4 sector 89
121002
faridabad
haryana
Faridabad
HARYANA |
07027058532
dangi.ishu29@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| srcdsr institutional ethical committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
FINISHED ORTHODONTIC TREATMENT PATIENTS |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Both |
| Details |
Patients whose orthodontic treatment is completed.
Wear the retainer for 20-22hr.
Wear the retainer for more than 3 months, except when eating.
Nonsmoker.
Without any medication that reduces saliva flow.
Patient compliance |
|
| ExclusionCriteria |
| Details |
Documented poor oral hygiene
Patients currently on antibiotics or having taken antibiotics 1 month prior to participating
in the study
Patients on chronic NSAIDs or chronic steroids |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| to determine which material have less microbiological colonies |
3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="14"
Sample Size from India="14"
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)
|
28/07/2025 |
| 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 aim of the study is to compare the microbiological colonies of conventional BEGGS RETAINER and 3D PRINTED RETAINER at different intervals of time during clinical wear. The main objective of the study is to evaluate the microbiological colonies present in the retainer before delivering, after 3 months the beggs retainer & 3D printed retainer and between the groups.Patients will be divided into 2 randomized groups.Patients of GROUP1 will be wearing conventional [ PMMA] retainer and GROUP 2 will be wearing 3D printed [TC85DAC] retainer. For each type test will be carried out before delivering and after 3 months of use.. Section of the POSTERIOR SURFACE of the upper right side will be taken before delivering and after 3 months and will be used for study .BRAIN HEART INFUSION BROTH will be used as transport media to transfer the section to laboratory and incubated for 24 hrs. Different Cultured medias prepared for different microorganisms –BLOOD AGAR for Total colony count,MITIS SALIVARIS AGAR for Streptococci bacteria,SABOURAUD DEXTROSE AGAR for Candida. Total colony forming count[CFU] will be calculated for each bacteria .All the data collected at before delivering and after 3rd months of investigation will be used to evaluate and compare the microbial colonies of the 2 different retainer.. Statistical analysis will be used for the same by ANOVA.
|