| CTRI Number |
CTRI/2024/12/078547 [Registered on: 24/12/2024] Trial Registered Prospectively |
| Last Modified On: |
19/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A0 study examining how often four different light-cured adhesives fail when used to attach orthodontic retainers to the inner surfaces of teeth. |
|
Scientific Title of Study
|
Comparison of failure rates of orthodontic fixed lingual retainers bonded with four light cured adhesives A prospective in vivo study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
PRIYANKA ANN KURUVILLA |
| Designation |
PG student |
| Affiliation |
KVG dental college and hospital sullia |
| Address |
Room no 7 Department of orthodontic and dentofacial orthopaedics KVG Dental College and Hospital Kurunjibhag Sullia D K Karnataka India Pincode 574327
Dakshina Kannada
KARNATAKA
574327
India |
| Phone |
09447564536 |
| Fax |
|
| Email |
priyankaann91@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mahesh kumar y |
| Designation |
Proffessor |
| Affiliation |
KVG dental college and hospital sullia |
| Address |
Room no 7 Department of orthodontic and dentofacial orthopaedics KVG Dental College and Hospital Kurunjibhag Sullia D K Karnataka India Pincode 574327
Dakshina Kannada
KARNATAKA
574327
India |
| Phone |
9448128842 |
| Fax |
|
| Email |
ymahesh2000@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mahesh kumar y |
| Designation |
Proffessor |
| Affiliation |
KVG dental college and hospital sullia |
| Address |
Room no 7 Department of orthodontic and dentofacial orthopaedics KVG Dental College and Hospital Kurunjibhag Sullia D K Karnataka India Pincode 574327
Dakshina Kannada
KARNATAKA
574327
India |
| Phone |
9448128842 |
| Fax |
|
| Email |
ymahesh2000@yahoo.com |
|
|
Source of Monetary or Material Support
|
| KVG Dental college and hospital Sullia DK Karnataka 574327 |
|
|
Primary Sponsor
|
| Name |
PRIYANKA ANN KURUVILLA |
| Address |
Room no 7 Department of orthodontic and dentofacial orthopaedics KVG Dental College and Hospital Kurunjibhag Sullia D K Karnataka India Pincode 574327 |
| 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 Priyanka Ann Kuruvilla |
KVG dental college and hospital sullia |
Room no 7 Department of orthodontic and dentofacial orthopaedics KVG Dental College and Hospital Kurunjibhag Sullia D K Karnataka India Pincode 574327
Dakshina Kannada
KARNATAKA |
9447564536
priyankaann91@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee kvg dental college and hospital |
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 |
Enlight (ormco) |
Enlight Bonding System Highly filled light-cure adhesive. Bis-GMA resin for superb handling characteristics, easy cleaning. Highly active initiater system supports reduced cure times.
Total Duration:1 year |
| Comparator Agent |
filtek supreme (3M Espe) flowable composite |
filtek supreme flowable composites provided satisfactory Shearbond strenght and wire pullout values, comparable to a standard orthodontic resin, and therefore can be used as an alternative for direct bonding of lingual retainers.
Total Duration:1 year |
| Intervention |
Tetric N flow (ivoclar vivadent) |
Tetric N-Flow is a light-curing, radiopaque flowable nano-hybrid composite based on nano-optimized technology. Tetric N-Flow is based on 10 years of tradition and the clinical performance of Tetric Flow. Because of the material’s outstanding wetting ability even in areas that are hard to reach, it is particularly suitable for use as a cavity liner and for small cavities of any kind. At the same time, the material offers outstanding stability and is thus ideal for Class V restorations.
Total Duration:1 year |
| Comparator Agent |
Transbond XT(3Munitek) |
Transbond XT light cure adhesive bonds metal and ceramic brackets to tooth surfaces providing dentists with additional working time for accurate bracket placement. Trans bond XT adhesive’s quick cure provides for immediate arch wire tie-in so patients and staffs can experience shorter bonding appoinments
Total Duration:1 year |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Both |
| Details |
Patients who have recently undergone comprehensive orthodontic treatment and requiring lingual bonded retainers.
Have no missing canines or incisors
No dental caries or restorations on the anterior tooth
No past history of retention devices
|
|
| ExclusionCriteria |
| Details |
Anterior crossbite
Serial extraction procedures
Patients who refuse to use a fixed retainer
High caries prevalence
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the in vivo failure rates of both maxillary and mandibular fixed lingual retainers bonded with four light cured adhesive materials. |
2 4 6 8 10 12 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To evaluate the failure rate of lingual bonded retainer bonded with Enlight (ormco) adhesive.
To evaulate the failure rate of lingual bonded retainer bonded with transbond XT (3M unitek) adhesive.
To evaluate the failure rate of lingual bonded retainer bonded with Filtek Supreme (3M Espe) flowable composite.
To evaluate the failure rate of lingual bonded retainer bonded with TetricR N Flow (ivoclar vivadent) composite.
To compare the failure rate of lingual bonded retainer with different adhesives.
|
2 4 6 8 10 12 months |
|
|
Target Sample Size
|
Total Sample Size="72"
Sample Size from India="72"
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)
|
10/01/2025 |
| 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="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
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
Modification(s)
|
Retention is an important phase after the completion of orthodontic treatment.In some cases,it is necessory to keep th lingual retainer in place for a long time to prevent teeth from shifting back to their original positions.All factors priorly researched and found to affect the in vivo stability or survival of fixed lingual retainers includind the usage of liquis resin,the type of different wire used,and the adhesive’s polymerisation technique throughout the time of bonding procedure.Relapse is frequently the result of failure of retainer or loss.Retainer failure can happen with wire fracture,at the enamel-composite contact,or at the composite-wire interface.The enamel-composite contact has been the source of the majority of recorded failures,and wire fracture are known to be directly correlates with the retainer’s age;the longer it remains in place,the risk of breakage wiil be higher.There are two types of fixed lingual retainer failure;partial and complete.The partial failure is indicated by attachement loss from one or more teeth,wherein full failure is indicated by completly falling of the teeth.complete failure is prefereable from a clinical standpoint to partial failure since the latter may be neglected by patient and lead to a return of the teeth back to their pretreatment state.This sudy is proposed to be conducted to compare bond strength of fixed lingual retainer with four different adhesive’s that is Tertic N flow(ivoclar),3M (Espe supreme flowable composite).Enlight ormco,Transbond XT light cured composite. |