| CTRI Number |
CTRI/2024/04/065159 [Registered on: 03/04/2024] Trial Registered Prospectively |
| Last Modified On: |
03/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of two types of fixed retainers placed on upper teeth for breakage in patients after completion of braces treatment |
|
Scientific Title of Study
|
Comparison of two types of fixed lingual retainers in maxillary arch for retainer failures in post-orthodontic patients – A 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 Chaulwar Chinmayee Sanjay |
| Designation |
PG Student |
| Affiliation |
Chhattisgarh dental college and research institute |
| Address |
Room no. 6, Department of Orthodontics and Dentofacial Orthopedics, Chhattisgarh dental college and research institute, Sundra, Rajnandgaon, Chhattisgarh, India. Pin code: 491441
Rajnandgaon
CHHATTISGARH
491441
India |
| Phone |
9730131867 |
| Fax |
|
| Email |
cchaulwar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Javed Sodawala |
| Designation |
Professor and Head of the department |
| Affiliation |
Chhattisgarh dental college and research institute |
| Address |
Room no. 6, Department of Orthodontics and Dentofacial Orthopedics, Chhattisgarh dental college and research institute, Sundra, Rajnandgaon, Chhattisgarh, India. Pin code: 491441
Rajnandgaon
CHHATTISGARH
491441
India |
| Phone |
7000858658 |
| Fax |
|
| Email |
drjavedazher@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Chaulwar Chinmayee Sanjay |
| Designation |
PG Student |
| Affiliation |
Chhattisgarh dental college and research institute |
| Address |
Room no. 6, Department of Orthodontics and Dentofacial Orthopedics, Chhattisgarh dental college and research institute, Sundra, Rajnandgaon, Chhattisgarh, India. Pin code: 491441
Rajnandgaon
CHHATTISGARH
491441
India |
| Phone |
9730131867 |
| Fax |
|
| Email |
cchaulwar@gmail.com |
|
|
Source of Monetary or Material Support
|
| Room no. 6, Department of Orthodontics and Dentofacial Orthopedics, Chhattisgarh dental college and research institute, Sundra, Rajnandgaon, Chhattisgarh, India. Pin code: 491441 |
|
|
Primary Sponsor
|
| Name |
Dr Chaulwar Chinmayee Sanjay |
| Address |
Room no. 6, Department of Orthodontics and Dentofacial Orthopedics, Chhattisgarh dental college and research institute, Sundra, Rajnandgaon, Chhattisgarh, India. Pin code: 491441 |
| 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 Chaulwar Chinmayee Sanjay |
Chhattisgarh dental college and research institute |
Room no. 6, Department of Orthodontics and Dentofacial Orthopedics, Chhattisgarh dental college and research institute, Sundra, Rajnandgaon, Chhattisgarh, India. Pin code: 491441
Rajnandgaon
CHHATTISGARH |
9730131867
cchaulwar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Chhattisgarh dental college and research institute |
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 |
Connected bonding pad fixed lingual retainer |
Placement of retainer on upper anterior teeth after completion of orthodontic treatment; and evaluation of post-treatment stability and retainer failure at different time intervals - immediately after placement (T0), one month after placement (T1), three months after placement (T3), and six months after placement(T6). |
| Comparator Agent |
Titanium wire fixed lingual retainer |
Placement of retainer on upper anterior teeth after completion of orthodontic treatment; and evaluation of post-treatment stability and retainer failures at different time intervals - immediately after placement (T0), one month after placement (T1), three months after placement (T3), and six months after placement(T6). |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients’ who have finished comprehensive fixed orthodontic treatment without the need of extraction.
2. Males and females between 18 to 30 years of age.
3. Patients willing to sign informed consent (self / parent / guardian) |
|
| ExclusionCriteria |
| Details |
1. Patients with systemic diseases or syndromes.
2. Pregnant women.
3. Patients who have been retreated following the relapse of previous orthodontic treatment.
4. Patients who need removable retainer in maxillary arch.
5. Individuals with special needs. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. To evaluate debonding rate and frequency of two types of bonded fixed lingual retainers in post-orthodontic patients.
2. To evaluate the posttreatment stability of two types of fixed lingual retainers in post-orthodontic patients. |
before placement of retainer (T0) and at designated stages (at one month: T1; at three months: T3; at six months: T6) after retainer placement |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To compare periodontal status in post-orthodontic patients bonded with two types of fixed lingual retainers.
2. To compare patient discomfort in post-orthodontic patients bonded with two different types of fixed lingual retainers. |
before placement of retainer (T0) and at designated stages (at one month: T1; at three months: T3; at six months: T6) after retainer placement |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
14/04/2024 |
| 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="1"
Months="0"
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
|
The purpose of our study is to evaluate and compare post-treatment stability and retainer failures of connected bonding pad retainers and titanium lingual wire retainers. Forty patients, reporting to the Department of Orthodontics and Dentofacial Orthopedics of Chhattisgarh Dental College and Research Institute, Rajnandgaon and indicated for fixed retainer after debonding of fixed orthodontic therapy will be selected (20 per group) as per inclusion and exclusion criteria. Twenty Patients will receive Connected bonding pad retainers in maxillary arch and twenty patients will receive Titanium lingual wire retainers in maxillary arch. After orthodontic treatment is completed; debonding will be done, followed by oral prophylaxis and cleaning of the tooth surface. Post-debond maxillary impressions will be made and good quality stone casts will be poured before placement of retainer (T0) and at designated stages (at one month: T1; at three months: T3; at six months: T6) after retainer placement. The six anterior teeth will be etched with 37% phosphoric acid for 15 sec, rinsed and air dried, followed by application of primer and curing for 5 seconds. Retainers adapted on the stone casts will then be positioned on the teeth and bonded to the six anterior teeth in a standard manner by bondable composite. Assessment would be done for failure rate, retainer stability, gingival and periodontal health and patient discomfort. |