| CTRI Number |
CTRI/2025/04/085154 [Registered on: 21/04/2025] Trial Registered Prospectively |
| Last Modified On: |
19/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Bacterial Colonization on Different Ceramic Braces: APC vs. Conventional |
|
Scientific Title of Study
|
A Comparative evaluation of Streptococcus mutans colony formation on APC ceramic and conventional ceramic bracket |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Nisha Pragya |
| Designation |
Post Graduate Student |
| Affiliation |
Inderprastha Dentaal College and Hospital |
| Address |
Room No-2, Third Floor,
Department of Orthodontics and Dentofacial Orthopaedics,
Inderprastha Dentaal College and Hospital, Site-4, Industrial area, Sahibabad
Ghaziabad
UTTAR PRADESH
201010
India |
| Phone |
9902654852 |
| Fax |
|
| Email |
nishapragya01@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Deepti Yadav |
| Designation |
Professor |
| Affiliation |
Inderprastha Dentaal College and Hospital |
| Address |
Room No-2, Third Floor,
Department of Orthodontics and Dentofacial Orthopaedics,
Inderprastha Dentaal College and Hospital, Site-4, Industrial area, Sahibabad
Ghaziabad
UTTAR PRADESH
201010
India |
| Phone |
9212794482 |
| Fax |
|
| Email |
deepti.yadav@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Nisha Pragya |
| Designation |
Post Graduate Student |
| Affiliation |
Inderprastha Dentaal College and Hospital |
| Address |
Room No-2, Third Floor,
Department of Orthodontics and Dentofacial Orthopaedics,
Inderprastha Dentaal College and Hospital, Site-4, Industrial area, Sahibabad
Ghaziabad
UTTAR PRADESH
201010
India |
| Phone |
9902654852 |
| Fax |
|
| Email |
nishapragya01@gmail.com |
|
|
Source of Monetary or Material Support
|
| Room No-2, Third Floor,
Department of Orthodontics and Dentofacial Orthopaedics,
Inderprastha Dentaal College and Hospital, Site-4, Industrial area, Sahibabad |
|
|
Primary Sponsor
|
| Name |
Nisha Pragya |
| Address |
Room No-2, Third Floor,
Department of Orthodontics and Dentofacial Orthopaedics,
Inderprastha Dentaal College and Hospital, Site-4, Industrial area, Sahibabad |
| 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 |
| nisha pragya |
Inderprastha Dental College and Hospital |
Room No-2, Third Floor,
Department of Orthodontics and Dentofacial Orthopaedics,
Inderprastha Dentaal College and Hospital, Site-4, Industrial area, Sahibabad
Ghaziabad
UTTAR PRADESH |
09902654852
nishapragya01@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
, (1) ICD-10 Condition: K038||Other specified diseases of hard tissues of teeth, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
APC Flash-Free adhesive-coated ceramic brackets (3M Unitek) bonded with Transbond Plus Self-etching Primer (3M Unitek)), |
The patients will have their brackets bonded using APC Flash-Free Bracket System with Self-Etching Primer (Transbond Plus Self Etching Primer (3M Unitek)) which will begin with cleaning the teeth, followed by drying. SEP will be applied directly to the enamel surface for 3 seconds18. The pre-coated brackets will be positioned with firm pressure, allowing the built-in nonwoven mat to absorb excess adhesive. Each bracket will then be cured for 10 seconds19 with Ivoclar Vivadent Bluephase LED Curing light at an Intensity of 1200mW/cm². |
| Comparator Agent |
Conventional ceramic bracket (3M Unitek gemini clear ceramic bracket) bonded with Transbond XT (3M Unitek). |
The patients will have conventional ceramic brackets bonded. The bonding procedure will begin with cleaning the teeth, followed by isolating them to maintain dryness. The enamel will then be etched with 37% phosphoric acid (Scotchbond, 3M ESPE) for 15 seconds20, followed by rinsing and drying. A frosted appearance will be checked before applying the adhesive. A primer (3M Unitek Transbond XT) will be applied and cured for 15 to 20 seconds21. A thin layer of adhesive (3M Unitek Transbond XT) will be coated on the base of the bracket then the bracket will be positioned precisely on the tooth and pressed firmly, with any excess adhesive removed. Each bracket will then be cured for 10 seconds19 with Ivoclar Vivadent Bluephase LED Curing light at an Intensity of 1200mW/cm². |
|
|
Inclusion Criteria
|
| Age From |
12.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
Patients with Angle’s Class I malocclusion
Tureskey Plaque Index Score Between 2-3.16• Indication for Fixed Orthodontic Treatment
Presence of All Mandibular Anterior Teeth
|
|
| ExclusionCriteria |
| Details |
Missing any permanent teeth with the exception of third molars
Use of Antimicrobial Mouth Rinses
Un co-operative Patient
Tureskey Plaque index above 4.16
Patients with Angle class II and class III malocclusion
• Syndromic Patient
• Cleft lip or cleft palate Patient
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Evaluate and compare the Streptococcus mutans colonization between APC and Conventional ceramic bracket ceramic to assess whether pre-coated adhesive technology reduces S. mutans accumulation over time. |
T0- Base Line
T1- 1 Months
T2- 6 Months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Evaluate & compare the Streptococcus mutans colonization between APC |
T0- Base line
T1- 1 Months
T2- 6 Months |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
12/05/2025 |
| 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 - 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 - Statistical Analysis Plan
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- 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 [nishapragya01@gmail.com].
- For how long will this data be available start date provided 10-03-2025 and end date provided 10-01-2025?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
| Aim of the study This study aims to evaluate and compare the Streptococcus mutans colonization between APC ceramic and conventional ceramic brackets to assess whether pre-coated adhesive technology reduces S. mutans accumulation over time. Objectives of the study · To evaluate the count of Streptococcus mutans bacterial colony after bonding with APC ceramic bracket. · To evaluate the count of Streptococcus mutans bacterial colony after bonding with conventional ceramic bracket. · Comparison of Streptococcus mutans colony counts on APC and conventional ceramic brackets. | Null hypothesis · There is no significant difference in the extent of Streptococcus mutans colony formation between different orthodontic bracket and adhesive types. | | |