| CTRI Number |
CTRI/2025/06/089645 [Registered on: 26/06/2025] Trial Registered Prospectively |
| Last Modified On: |
25/06/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
Assessment of Adhesive Remnant using disclosing solution on enamel surfaces after orthodontic debonding |
|
Scientific Title of Study
|
Assessment of remnant adhesive after orthodontic debonding with and without the use of a disclosing solution- A Non Randomized clinical 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 Shobha Sundareswaran |
| Designation |
Professor |
| Affiliation |
KMCT Dental College |
| Address |
KMCT Dental College
Department of Orthodontics, 5th floor, Manassery, Mukkom
Kozhikode
Kozhikode
KERALA
673602
India |
| Phone |
9447067245 |
| Fax |
|
| Email |
dr.shobha@kmctdentalcollege.org |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shobha Sundareswaran |
| Designation |
Professor |
| Affiliation |
KMCT Dental College |
| Address |
KMCT Dental College
Department of Orthodontics, 5th floor,
Manassery,Mukkom
Kozhikode
Kozhikode
KERALA
673602
India |
| Phone |
9447067245 |
| Fax |
|
| Email |
dr.shobha@kmctdentalcollege.org |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shobha Sundareswaran |
| Designation |
Professor |
| Affiliation |
KMCT Dental College |
| Address |
KMCT Dental College
Deoartment of Orthodontics, 5thfloor, Manassery,Mukkom
Kozhikode
Kozhikode
KERALA
673602
India |
| Phone |
9447067245 |
| Fax |
|
| Email |
dr.shobha@kmctdentalcollege.org |
|
|
Source of Monetary or Material Support
|
| KMCT Dental College
Department of Orthodontics, 5th floor
Manassery,Mukkom
Kozhikode 673602 |
|
|
Primary Sponsor
|
| Name |
KMCT Dental College |
| Address |
Department of Orthodontics, 5th floor, Manassery
Mukkom.Kozhikode-673602,Kerala,India |
| 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 Shobha Kumar |
KMCT Dental College |
Department of Orthodontics,5th floor, KMCT Dental College, Manassery,Mukkom.
Kozhikode
KERALA |
09447067245
dr.shobha@kmctdentalcollege.org |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee,KMCT Dental College |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K089||Disorder of teeth and supporting structures, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Adhesive remnant assessment with disclosing solution |
Assessment of remaining adhesive on enamel surface using ARI score with disclosing solution |
| Comparator Agent |
Adhesive remnant assessment without disclosing solution for 2 months |
Assessment of remaining adhesive on enamel surface using ARI index for 2 months |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Both |
| Details |
1 Upper anterior teeth including the four incisors and two canines (total 6)
2 Intact enamel surface |
|
| ExclusionCriteria |
| Details |
Teeth with caries, restoration, enamel cracks, stains, demineralization, severe pitting or atypical intrinsic stains. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Amount of adhesive remaining on the enamel surface after debonding |
3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Time taken for assesssing the adhesive remaining on the enamel surface after debonding |
3 months |
|
|
Target Sample Size
|
Total Sample Size="41"
Sample Size from India="41"
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
|
Phase 2 |
|
Date of First Enrollment (India)
|
30/07/2025 |
| 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="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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 goal of debonding in Orthodontics is to remove the bracket and resin adhesive with as little damage as possible to the enamel. This is not an easy task as orthodontic adhesives are tooth coloured making it very difficult to distinguish the resin remnants from the enamel surface.Differentiation of remaining adhesive resin under direct visualization is needed in a clinical setting. Therefore, this study aims to asses and compare the amount of resin detected on the enamel surface following debonding with and without the use of a disclosing solution in a clinically useful scenario and also to compare the time taken to identify above remnant resin with and without the use of a disclosing solution. |