| CTRI Number |
CTRI/2023/08/056863 [Registered on: 24/08/2023] Trial Registered Prospectively |
| Last Modified On: |
22/08/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized Factorial Trial |
|
Public Title of Study
|
Evaluating the adhesive performance of various orthodontic brackets on teeth affected by fluorosis using two different orthodontic adhesives that exhibit color alteration. |
|
Scientific Title of Study
|
Comparative evaluation of shear bond strength of different orthodontic brackets bonded with two different colour change orthodontic adhesives on fluorosed teeth. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Monjeet Goswami |
| Designation |
PG student |
| Affiliation |
Kalka Dental College and Hospital |
| Address |
Department of Orthodontics Kalka Dental College and Hospital Partapur Bypass Road Meerut
Meerut
UTTAR PRADESH
250103
India |
| Phone |
8584039338 |
| Fax |
|
| Email |
monu.gos36@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Shipra Nagar |
| Designation |
Professor and HOD |
| Affiliation |
Kalka Dental College and Hospital |
| Address |
Department of Orthodontics Kalka Dental College and Hospital Partapur Bypass Road Meerut
Meerut
UTTAR PRADESH
250103
India |
| Phone |
9971822949 |
| Fax |
|
| Email |
shipray@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr. Shipra Nagar |
| Designation |
Professor and HOD |
| Affiliation |
Kalka Dental College and Hospital |
| Address |
Department of Orthodontics Kalka Dental College and Hospital Partapur Bypass Road Meerut
Meerut
UTTAR PRADESH
250103
India |
| Phone |
9971822949 |
| Fax |
|
| Email |
shipray@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Kalka Dental College and Hospital Partapur Bypass Road Meerut UP 250306 |
|
|
Primary Sponsor
|
| Name |
Kalka Dental College and Hospital |
| Address |
Partapur Bypass Road Meerut Uttar Pradesh 250103 |
| Type of Sponsor |
Private medical college |
|
|
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 Monjeet Goswami |
Kalka Dental College And Hospital |
Department of Orthodontics Kalka Dental College And Hospital Partapur Bypass Road
Meerut
UTTAR PRADESH |
8584039338
monu.gos36@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee Kalka Dental College Meerut |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy extracted tooth |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Conventional and self ligating brackets |
Bond strength comparison between metal and ceramic conventional and self ligating brackets |
| Comparator Agent |
Metal and ceramic brackets |
Bond strength comparison between metal and ceramic brackets |
| Comparator Agent |
Two different colour change adhesives |
Bond strength comparison between metal and ceramic conventional and self ligating brackets using two different colour change adhesives |
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Extracted premolar for orthodontic treatment
2.Mild to moderate fluorosis
3.4 different brackets are used for checking the bond strength
4.LED Light cure unit
|
|
| ExclusionCriteria |
| Details |
1.Excessive caries
2.Excessive attritted teeth
3.Fractured tooth
4.Teeth with abnormal morphology.
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the shear bond strength of self-ligating brackets (metal & ceramic) & conventional bracket (metal & ceramic) which are bonded on fluorosed teeth |
8 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare the shear bond strength of self-ligating brackets (metal & ceramic) & conventional bracket (metal & ceramic) which are bonded on fluorosed teeth |
4 weeks |
|
|
Target Sample Size
|
Total Sample Size="44"
Sample Size from India="44"
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
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
04/09/2023 |
| 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="5"
Days="30" |
|
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 - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response - Proposals should be directed to [drmonjeetgoswami@gmail.com].
- For how long will this data be available start date provided 10-07-2023 and end date provided 10-01-3000?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
The success of orthodontic
treatment relies on the bonding of brackets to enamel. However, bracket bonding
failure is a common issue, especially when bonding on fluorosed enamel, which
is more porous and hypomineralized. Fluorosed enamel contains acid-resistant
crystals and a higher protein content, compromising bonding. Alternative
treatments are proposed to improve bracket retention, such as intraoral sandblasting
to increase surface roughness or deproteinization using sodium hypochlorite
(NaOCl) to remove organic elements. The conversion of resin cement into a
polymer is also important for successful bonding.
AIM AND OBJECTIVES
AIM
The aim of this
study is to compare the shear bond strength of self-ligating brackets (metal
& ceramic) and conventional bracket (metal & ceramic) which are bonded
on fluorosed teeth.
OBJECTIVES
To investigate the effect of fluorosis on shear bond strength,
etching time, adhesive remnant index score (ARI) when bonding different
orthodontic brackets on fluorosed enamel.
METHODOLOGY ·
The sample consisted of 44
human fluorosed extracted for orthodontic purposes. Teeth were stored in
formalin until bonding procedures. ·
The sample size (n = 44) was
estimated with power analysis to provide statistical significance alpha = 0.05
at an 80% power. ·
44 fluorosed teeth were divided
into 4 groups of 11 each and bonded with different brackets. ·
Before bonding, the facial
surfaces of the teeth were cleaned with a mixture of water and pumice. ·
The teeth were rinsed
thoroughly with water and dried with compressed air. ·
Each tooth is etched with 37%
phosphoric acid gel for 30 seconds. Then, all teeth will be rinsed with
water/spray combination for 30 seconds and dried. ·
Polymerization of the bonding
agent will be performed with a conventional LED curing light for 15 seconds for
ceramic brackets and 20 seconds for metal brackets. ·
Before determining the shear
bond strength and subsequent debonding,
bonded teeth are stored in distilled water for 24 hours. ·
The shear bond strength tests
will be performed at a crosshead speed of 1 mm/min during debonding. The
shearing debonding force is directed occluso-gingivally and recorded in MPa.
Bond strengths were compared by ANOVA test. ·
A stereomicroscope at a
magnification of 20x will be used to assess the amount of adhesive remaining on
the teeth and the brackets after debonding and will be scored according to the
adhesive remnant index (ARI).
·
If deemed, necessary changes
will be made in the best interest of the study. |