| CTRI Number |
CTRI/2025/08/093577 [Registered on: 25/08/2025] Trial Registered Prospectively |
| Last Modified On: |
22/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Study in patients with braces to compare the effect of two types of glue on the development of white marks on teeth |
|
Scientific Title of Study
|
Comparison of bioactive and conventional adhesives on white spot lesion formation during fixed orthodontic treatment – a randomized clinical trial. |
| Trial Acronym |
NILL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Prerna |
| Designation |
Junior Resident |
| Affiliation |
AIIMS New Delhi |
| Address |
Room No. 416, 4th Floor, Department of Orthodontics and Dentofacial Deformities, CDER, AIIMS, New Delhi – 110029
South West
DELHI
110029
India |
| Phone |
8527520798 |
| Fax |
|
| Email |
prernav55@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vilas Samrit |
| Designation |
Additional Professor |
| Affiliation |
AIIMS New Delhi |
| Address |
Room No. 415, 4th Floor, Department of Orthodontics and Dentofacial Deformities, CDER, AIIMS, New Delhi – 110029
South West
DELHI
110029
India |
| Phone |
9899503560 |
| Fax |
|
| Email |
vilassamrit@live.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vilas Samrit |
| Designation |
Additional Professor |
| Affiliation |
AIIMS New Delhi |
| Address |
Room No. 415, 4th Floor, Department of Orthodontics and Dentofacial Deformities, CDER, AIIMS, New Delhi – 110029
South West
DELHI
110029
India |
| Phone |
9899503560 |
| Fax |
|
| Email |
vilassamrit@live.in |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
DR PRERNA |
| Address |
Room No. 416, 4th floor, Department of Orthodontics and Dentofacial Deformities, CDER, AIIMS, New Delhi-110029 |
| 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 Prerna |
CDER, AIIMS, New Delhi |
Room No. 416, 4th Floor, Department of Orthodontics and Dentofacial Deformities, CDER, AIIMS, New Delhi – 110029
South West
DELHI |
08527520798
prernav55@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee for Post Graduate Research |
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 |
BIOACTIVE ADHESIVE |
In the bioactive adhesive group, orthodontic brackets will be bonded using ACTIVA BioACTIVE Restorative, a light-cured, resin-modified bioactive material that releases and recharges calcium, phosphate, and fluoride ions. The adhesive will be applied once at the start of fixed orthodontic treatment, on one side of the dental arch (split-mouth design), following the manufacturers instructions. This intervention is designed to reduce enamel demineralization and prevent white spot lesion formation around brackets. The total duration of the intervention corresponds to the entire period of fixed appliance therapy, which is expected to last approximately 12 to 18 months, depending on the individual treatment plan. |
| Comparator Agent |
CONVENTIONAL ADHESIVE |
In the conventional adhesive group, orthodontic brackets will be bonded using Transbond XT, a widely used light-cured, resin-based adhesive. The adhesive will be applied once at the start of fixed orthodontic treatment, on the contralateral side of the dental arch (as part of the split-mouth design), following the manufacturer’s instructions. This group will serve as the control to evaluate and compare the incidence of white spot lesion formation around brackets. The intervention will continue for the entire duration of fixed appliance therapy, estimated to be approximately 12 to 18 months, based on individual treatment needs.
|
|
|
Inclusion Criteria
|
| Age From |
12.00 Year(s) |
| Age To |
25.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients aged 12–25 years irrespective of gender.
2.Fixed orthodontic treatment with extraction or non-extraction treatment plan.
|
|
| ExclusionCriteria |
| Details |
1.Patients with poor oral hygiene or systemic diseases affecting salivary flow.
2.Patients on medications affecting oral microbiota or calcium metabolism.
3.Patients not willing to participate in the study.
4.No pre-existing enamel lesions or restorations on labial surfaces of teeth. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The primary outcome of this study is to compare the two adhesives in minimizing the formation of white spot lesions during fixed orthodontic appliance therapy, evaluated over a 6-months and 12 months period. |
T0- Before treatment
T1- after 6 months
T2- After 12 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Secondary Outcomes include the severity and distribution of WSLs (mesial, distal, gingival, or occlusal to the bracket). These will be documented to assess lesion pattern distribution using Quantitative Light-induced Fluorescence (QLF). |
T0- Before treatment
T1- after 6 months
T2- After 12 months |
|
|
Target Sample Size
|
Total Sample Size="15"
Sample Size from India="15"
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 3 |
|
Date of First Enrollment (India)
|
15/09/2025 |
| 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="1"
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
|
This randomized split-mouth clinical trial aims to compare the effect of a bioactive adhesive and a conventional adhesive on the development of white spot lesions during fixed orthodontic treatment. Orthodontic brackets will be bonded using the bioactive adhesive on one side of the dental arch and the conventional adhesive on the opposite side in each patient. The occurrence of white spot lesions around brackets will be evaluated over time using standardized clinical methods to determine whether the bioactive material offers superior protection against enamel demineralization. |