| CTRI Number |
CTRI/2024/11/076891 [Registered on: 18/11/2024] Trial Registered Prospectively |
| Last Modified On: |
13/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Impact of Rubber Dam Isolation on Failure Rates of Mandibular Fixed Orthodontic Retainers: A Comparative Study |
|
Scientific Title of Study
|
Comparative Evaluation of failures of mandibular fixed orthodontic retainers placed with or without rubber dam isolation: 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 |
MEGHA SARKAR |
| Designation |
POST GRADUATE RESIDENT |
| Affiliation |
Bharti Vidyapeeth Dental College and Hospital , |
| Address |
Dept of Orthodontics, First floor, Bharti Vidyapeeth Dental College and Hospital ,
Sector 7, CBD Belapur, Navi Mumbai, Maharashtra 400614
Thane
MAHARASHTRA
400614
India |
| Phone |
9108913818 |
| Fax |
|
| Email |
diasarkar14@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
HARSH MISHRA |
| Designation |
POST GRADUATE RESIDENT |
| Affiliation |
Bharti Vidyapeeth Dental College and Hospital , |
| Address |
Dept of Orthodontics, First floor, Bharti Vidyapeeth Dental College and Hospital ,
Sector 7, CBD Belapur, Navi Mumbai, Maharashtra 400614
Thane
MAHARASHTRA
400614
India |
| Phone |
8451840579 |
| Fax |
|
| Email |
dr.mishraharsh@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
MEGHA SARKAR |
| Designation |
POST GRADUATE RESIDENT |
| Affiliation |
Bharti Vidyapeeth Dental College and Hospital , |
| Address |
Dept of Orthodontics, Bharti Vidyapeeth Dental College and Hospital ,
Sector 7, CBD Belapur, Navi Mumbai, Maharashtra 400614
Thane
MAHARASHTRA
400614
India |
| Phone |
9108913818 |
| Fax |
|
| Email |
diasarkar14@gmail.com |
|
|
Source of Monetary or Material Support
|
| Bharti Vidyapeeth Dental College and Hospital,
Dept of Orthodontics,
Sector 7, CBD Belapur, Navi Mumbai, Maharashtra- 400614, INDIA |
|
|
Primary Sponsor
|
| Name |
BHARTI VIDYAPEETH DEPT OF ORTHODONTICS |
| Address |
Bharti Vidyapeeth Dental College and Hospital,
Dept of Orthodontics,
Sector 7, CBD Belapur, Navi Mumbai, Maharashtra- 400614, INDIA |
| Type of Sponsor |
Research institution and hospital |
|
|
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 MEGHA SARKAR |
Bharti Vidyapeeth Dental College and Hospital |
Department of Orthodontics, First floor, PG clinic, 23H3+6RQ, Sector 7, CBD Belapur, Navi Mumbai, Maharashtra 400614
Thane
MAHARASHTRA |
9108913818
diasarkar14@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ETHICS COMMITTEE FOR BIOMEDICAL AND HEALTH RESEARCH |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M263||Anomalies of tooth position of fully erupted tooth or teeth, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Orthodontic retainer with rubber dam |
Direct Bonding of the retainer: Complete Oral prophylaxis will be performed post which there will be Rubber dam placement. Lingual surfaces will be pumiced and etched with 37% phosphoric acid. Etchant will be applied on the lingual surfaces of the anteriors, will rinse it with three-way syringe and dry it with three-way syringe, followed by application of bonding agent and then light cure it for 10 seconds on each tooth. The mandibular fixed retainer will then be transferred from the plaster model to the dental arch, will be checked for proper adaptation followed by Composite application, followed by Light curing using a light-emitting diode curing light (3M,Elipar).
This shall be performed on the patient once at the first visit which would take about 30 mins and the effect shall be observed on subsequent follow up. |
| Comparator Agent |
Orthodontic retainer without rubber dam |
Complete Oral prophylaxis will be performed post which the Lingual surfaces will be pumiced and etched with 37% phosphoric acid.
Etchant will be applied on the lingual surfaces of the anteriors, will rinse it with three-way syringe and dry it with three-way syringe, followed by application of bonding agent and then light cure it for 10 seconds on each tooth.
The mandibular fixed retainer will then be transferred from the plaster model to the dental arch, will be checked for proper adaptation followed by Composite application, followed by Light curing using a light-emitting diode curing light (3M,Elipar).
This shall be performed on the patient once at the first visit which would take about 30 mins and the effect shall be observed on subsequent follow up. |
|
|
Inclusion Criteria
|
| Age From |
17.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
Patients with well finished, post orthodontic occlusion.
Patients with absence of any nail-biting, pencil/pen-biting habit, and absence of Tongue-thrusting habit.
Patients with extraction or non-extraction.
Absence of active caries, restorations, fractures and periodontal disease |
|
| ExclusionCriteria |
| Details |
Patient with claustrophobia
Patient with periodontally compromised dentition
Patients with presence of any abnormal morphology of teeth.
Patients with missing teeth.
Patients with inadequate hygiene
Patient in need for restorative or surgical treatment
Presence of fractures |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The outcome of this study will be to record frequency of failures (breakage or debonding of the mandibular fixed retainer) in the mandibular lingual fixed retainer post placement with and without rubber dam. |
The patients will be followed-up at approximately at an interval of 0,3, 6 months after bonding |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To compare the duration in placement of mandibular fixed orthodontic retainer in the group comprising the usage of rubber dam and in the group comprising without the usage of rubber dam isolation
To determine the changes in tooth position post placement of mandibular fixed orthodontic retainer in both the groups (with and without the usage of rubber dam) via Little’s Irregularity Index |
3 months and 6 months |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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
|
N/A |
|
Date of First Enrollment (India)
|
28/11/2024 |
| 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="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
|
Need for Research: Fixed Orthodontic retainer’s integrity is crucial in sustaining the successful orthodontic treatment results over a period of time. The placement procedure of fixed orthodontic retainers requires uttermost isolated intraoral environment from saliva in the presumption of best bonding and longevity of placement. The rubber dam isolation technique has been proven gold standard in intra oral restorative procedures however its potentials have not been explored in full in orthodontics due to cumbersome placement procedure and additional inventory. Considering role of intact fixed orthodontic retainer in preventing the side effect of ill-fitting or untimely dislodgment of fixed orthodontic retainer, it becomes imperative to ascertain the isolated environment by using rubber displacement of fixed orthodontic retainer to retain the finished orthodontic objectives. Hence the present study proposes to assess the comparative evaluation of failures of mandibular fixed orthodontic retainers placed with or without rubber dam isolation: A Randomized control trial. Comparative evaluation of failures of fixed mandibular orthodontic retainers placed with or without rubber dam isolation.
|