| CTRI Number |
CTRI/2024/07/071504 [Registered on: 29/07/2024] Trial Registered Prospectively |
| Last Modified On: |
01/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
 to know the impact of three orthodontic adhesive removal techniques and time on the release of bisphenol in saliva following debonding in orthodontic patients. |
|
Scientific Title of Study
|
ffect of three orthodontic adhesive removal techniques and time on
bisphenol in saliva after debonding in orthodontic patients- a
randomized controlled 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 |
Dr Suresh Kangane |
| Designation |
Principal, H.O.D and Professor |
| Affiliation |
Maharashtra Institute of Dental Sciences and Research (Dental College), Latur Maharashtra |
| Address |
Department of Orthodontics and Dentofacial Orthopedics MIDSR Dental College, Latur
Latur
MAHARASHTRA
413512
India |
| Phone |
9823567063 |
| Fax |
|
| Email |
drsureshkangane@rediffmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr.Suresh Kangane |
| Designation |
Principal , H.O.D. & Professor |
| Affiliation |
Maharashtra Institute of Dental Sciences and Research (Dental College), Maharashtra |
| Address |
Department of Orthodontics and Dentofacial Orthopedics MIDSR Dental College, Latur
Latur
MAHARASHTRA
413512
India |
| Phone |
9823267063 |
| Fax |
|
| Email |
drsureshkangane@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Aavesh Bhoir |
| Designation |
PG student |
| Affiliation |
MIDSR dental college latur |
| Address |
DEPARTMENT OF ORTHODONTICS AND DENTOFACIAL ORTHOPEDICS MIDSR DENTAL COLLEGE
Latur
MAHARASHTRA
413512
India |
| Phone |
9967268848 |
| Fax |
|
| Email |
bhoiraavesh123@gmail.com |
|
|
Source of Monetary or Material Support
|
| Self-supported by ( Dr. Trupti Shankar Nakhate and Dr. Suresh Kangane). Monetary support
from Maharashtra Institute of Dental Sciences and Research Dental College Latu |
|
|
Primary Sponsor
|
| Name |
MIDSR dental college latur |
| Address |
Room no 7 department of orthdontics , MIDSR DENTAL COLLEGE , Ambajogai road Latur Maharsashtra 413512 |
| 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 Aavesh Bhoir |
MIDSR dental college , latur |
ROOM NO 7 , department of orthodontic and dentofacial orthopedic MIDSR dental college latur Maharashtra 413512
Latur
MAHARASHTRA |
9967268848
bhoiraavesh123@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| institutional ethical committee MIDSRlatur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K117||Disturbances of salivary secretion, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
composite finishing bur |
it is used to remove residual adhesive after debonding
duration - 2 min
bur specifications- MANI TR-26EF |
| Comparator Agent |
control group |
Before debonding, the brackets, 1 mL unstimulated saliva will be collected from the buccal vestibule and sublingual area by a blinded clinician using calibrated pipettes. |
| Intervention |
tungsten carbide bur |
it is used for removal of residual adhesive on enamel surface.
duration - 2 minutes
bur specification - MANI TR15 |
| Intervention |
Ultrasonic scaler |
it is used to remove residual adhesive after debonding.
duration - 2 min
specifications - mini-piezon EMS |
|
|
Inclusion Criteria
|
| Age From |
12.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Both |
| Details |
Patients aged 12-35 years undergoing orthodontic treatment and are at the stage of completion or debonding
Patients who demonstrated good oral hygiene.
Comprehensive orthodontic treatment cases with minimum 16 brackets requiring debonding
|
|
| ExclusionCriteria |
| Details |
Patients consuming tobacco in any form (smoking or chewing)
Patients who have hepatic or renal diseases
Patients who are taking any medications containing phenolic compounds.
patients with composite resin restorations on their teeth.
Patients who are diagnosed with xerostomia
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To evaluate level of bisphenol in saliva after removal of residual adhesive with tungsten carbide bur.
To evaluate level of bisphenol in saliva after removal of residual adhesive with composite finishing bur.
To evaluate level of bisphenol in saliva after removal of residual adhesive with ultrasonic scaler.
|
1 YEAR |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To compare the level of bisphenol before debonding (control group) with three different residual adhesive removal techniques.
To compare level of bisphenol in saliva with respect to time required to remove residual adhesive from tooth surface.
|
1 YEAR |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "40"
Final Enrollment numbers achieved (India)="40" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
19/10/2024 |
| Date of Study Completion (India) |
19/12/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Bisphenol may released into orthodontic patients saliva during debonding process. finding debonding techniques that result in least amount of released bisphenol in saliva is crucial. according to researcher of this study there is presently research evaluating impact of various debondng techniques on amount of bisphenol released in saliva using rotary and ultrasonic procedures. so purpose of this study is to compare amount of bisphenol released in saliva after debonding and residual composite removal with tungstun carbide bur , composite finishing bur , ultrasinic scaler. |