| CTRI Number |
CTRI/2022/06/043125 [Registered on: 09/06/2022] Trial Registered Prospectively |
| Last Modified On: |
|
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
An evaluation of the efficacy of labial versus lingual bonded retainers: An in-vivo study. |
|
Scientific Title of Study
|
An evaluation of the efficacy of labial versus lingual bonded retainers: An in-vivo study. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Rinchin Yangzom |
| Designation |
2nd Year Post Graduate Student |
| Affiliation |
Subharti Dental College and Hospital |
| Address |
Department of Orthodontics and Dentofacial Orthopaedics, Subharti Dental College and Hospital, Swami Vivekanand Subharti University, NH-58, Delhi-Haridwar Bypass Road
Meerut
UTTAR PRADESH
250005
India |
| Phone |
7409272987 |
| Fax |
|
| Email |
rinchinyangzom@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
C Munish Reddy |
| Designation |
Professor, Department of Orthodontics and Dentofacial Orthopaedics |
| Affiliation |
Subharti Dental College and Hospital |
| Address |
Department of Orthodontics and Dentofacial Orthopaedics, Subharti Dental College and Hospital, Swami Vivekanand Subharti University, NH-58, Delhi-Haridwar Bypass Road
Meerut
UTTAR PRADESH
250005
India |
| Phone |
7533866667 |
| Fax |
|
| Email |
drmunishreddy@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rinchin Yangzom |
| Designation |
2nd Year Post Graduate Student |
| Affiliation |
Subharti Dental College and Hospital |
| Address |
Department of Orthodontics and Dentofacial Orthopaedics, Subharti Dental College and Hospital, Swami Vivekanand Subharti University, NH-58, Delhi-Haridwar Bypass Road
Meerut
UTTAR PRADESH
250005
India |
| Phone |
7409272987 |
| Fax |
|
| Email |
rinchinyangzom@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Orthodontics and Dentofacial Orthopaedics, Subharti Dental College and Hospital, Swami Vivekanand Subharti University, NH-58, Delhi-Haridwar Bypass Road |
|
|
Primary Sponsor
|
| Name |
Dr Rinchin Yangzom |
| Address |
Department of Orthodontics and Dentofacial Orthopaedics, Subharti Dental College and Hospital, Swami Vivekanand Subharti University, NH-58, Delhi-Haridwar Bypass Road |
| 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 Rinchin Yangzom |
Subharti Dental College and Hospital |
Department of Orthodontics and Dentofacial Orthopaedics,Room No. 7 2nd floor Subharti Dental College and Hospital, Swami Vivekanand Subharti University, NH-58, Delhi-Haridwar Bypass Road
Meerut
UTTAR PRADESH |
7409272987
rinchinyangzom@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institution of Ethical Committee, Subharti Dental College |
Approved |
|
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Regulatory Clearance Status from DCGI
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Patients requiring retainers after completion of fixed orthodontic treatment. |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Labial bonded retainer with teflon-coated ligature wire |
After completion of fixed orthodontic treatment, the participants will receive labial bonded retainers after debonding. They will be recalled for follow-up every 3 months for a period of 9 months. |
| Comparator Agent |
Lingual bonded retainer with a twisted 0.010" stainless steel ligature wire |
After completion of fixed orthodontic treatment, the participants will receive lingual bonded retainers after debonding. They will be recalled every 3 months for a period of 9 months |
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Both |
| Details |
1.Subjects’ willingness to participate.
2.Age between 15-30 years.
3.Completion of fixed orthodontic treatment.
4.Both extraction and non-extraction cases.
5.No mutilated and congenitally missing teeth.
6.Absence of prosthesis (crowns, bridges, implants) and restorations.
7.Absence of parafunctional habits.
8.Absence of periodontal or gingival problems.
9.Presence of normal bite.
|
|
| ExclusionCriteria |
| Details |
1.Patients with mutilated and congenitally missing teeth.
2.Presence of prosthesis and restorations.
3.Presence of periodontal or gingival disease.
4.Patients with history of parafunctional habits.
5.Presence of deep bite.
6.Patients with poor oral hygiene.
7.Patients prone to caries.
|
|
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Method of Generating Random Sequence
|
Permuted block randomization, fixed |
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Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To compare and evaluate the efficacy of Labial versus Lingual surface bonded retainers
|
9 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To evaluate the effects of both labial and lingual surface bonded retainers on the periodontal health and oral hygiene status of the patients.
|
9 months |
To evaluate the labial surface bonded retainers’ esthetic perception by general public.
|
9 months |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
13/06/2022 |
| 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="9"
Days="7" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
None |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Retention after treatment remains one of the greatest challenges in orthodontics. It is one of the controversies of modern orthodontics, with uncertainty being the only certainty. Angle stated that "the problem involved in retention is so great as to test the utmost skill of the most competent orthodontist, often being greater than the difficulties being encountered in the treatment of the case up to this point. ’’ The etiology of orthodontic relapse is complex and multifactorial. The identified related factors include tension from the periodontal fibers, the final occlusion, pressure from the soft tissues, growth, and age advancement. The risk of relapse is unpredictable and concerns a high proportion of post-orthodontic patients. There is evidence that during the post-retention period, 70-90% of the cases show some relapse in the lower arch; the upper arch is also affected but to a lesser extent. Many appliance types have been used for the retention of post-treatment tooth position. The first appliances proposed were based on banded fixed appliances, then removable retainers were advocated. After this, the use of bonded fixed retainers had been introduced. The advent of acid-etch technique heralded a new era in dentistry, however, it was some time before acid etching of enamel was applied in orthodontics. Newman first reported direct bonding of orthodontic attachments to tooth surfaces in 1965. Kneirim published the first report of the use of this technique to construct bonded fixed retainers. Early bonded fixed retainers were made with plain round or rectangular orthodontic wires, but Zachrisson proposed the potential advantages of the use of a multistrand wire for the construction of a canine-to-canine bonded fixed retainer. In this retainer the wire was bonded to the canine teeth only. In 1983 Zachrisson again reported the use of a multistrand wire in a bonded fixed retainer in which the wire was bonded to all the teeth in the labial segment. Currently, the flexible multistranded wire bonded to each anterior tooth is considered the gold standard. The preference to this retainer is attributed to the assumed extra mechanical retention to the composite resin due to the strands, and the wire’s flexibility that permits physiological tooth mobility and reduced tension in the composite. Now ideally, the choice of appropriate retainer for each individual patient should be made considering not only the clinical effectiveness, but also the patient’s ability to, and willingness to comply with the retention plan. Nowadays, a majority of the patients, being adolescents, are concerned about esthetics and do not favour a metallic wire being displayed whenever they speak or smile. So, the lingually-bonded retainers, being invisible, are preferred by most patients. However, it has certain drawbacks. If broken at some sites, it goes unnoticed by the patient for a long time and finally relapse occurs. Moreover, there are more chances of plaque and calculus retention in this type of retainers. Hence, keeping these points in mind, we can say that the labially-bonded retainers surpass the disadvantages of lingually-bonded retainers. However, many patients still do not prefer this due to unaesthetic reasons. Therefore, the purpose of this study is to evaluate the efficacy of labial versus lingual bonded retainers and also to evaluate the periodontal and oral hygiene status along with bond failures associated with both the retainers. |