| CTRI Number |
CTRI/2020/03/023962 [Registered on: 13/03/2020] Trial Registered Prospectively |
| Last Modified On: |
12/03/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Other |
|
Public Title of Study
|
To check treatment effects in comparison with usage of lower jaw repositioning appliance with Digital sensor timer |
|
Scientific Title of Study
|
Assessment of treatment efficacy in relation to wear time of Twin Block with Electronic timing device |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR NIKITA RAVINDRA BAHETI |
| Designation |
Post graduate student |
| Affiliation |
Government Dental College and Hospital, Nagpur |
| Address |
101, PG section, Department of Orthodontics and Dentofacial Orthopaedics, Government dental college and hospital, Medical campus, Medical square, Nagpur 101, PG section, Department of Orthodontics and Dentofacial Orthopaedics, Government dental college and hospital, Medical campus, Medical square, Nagpur Nagpur MAHARASHTRA 440003 India |
| Phone |
9422712340 |
| Fax |
|
| Email |
nikita.baheti3@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
DR NIKITA RAVINDRA BAHETI |
| Designation |
Post graduate student |
| Affiliation |
Government Dental College and Hospital, Nagpur |
| Address |
101, PG section, Department of Orthodontics and Dentofacial Orthopaedics, Government dental college and hospital, Medical campus, Medical square, Nagpur 101, PG section, Department of Orthodontics and Dentofacial Orthopaedics, Government dental college and hospital, Medical campus, Medical square, Nagpur Nagpur MAHARASHTRA 440003 India |
| Phone |
9422712340 |
| Fax |
|
| Email |
nikita.baheti3@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
DR WASUNDHARA BHAD |
| Designation |
Professor and Head of Department |
| Affiliation |
Government Dental College and Hospital, Nagpur |
| Address |
HOD Chamber, Department of Orthodontics and Dentofacial Orthopaedics, Government dental college and hospital, Medical campus, Medical square, Nagpur HOD Chamber, Department of Orthodontics and Dentofacial Orthopaedics, Government dental college and hospital, Medical campus, Medical square, Nagpur Nagpur MAHARASHTRA 440003 India |
| Phone |
9890227819 |
| Fax |
|
| Email |
wasundharabhad@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Orthodontics and Dentofacial Orthopaedics, Government dental college and hospital, Medical campus, Medical square, Nagpur- 440003 |
|
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Primary Sponsor
|
| Name |
Self Sponsor |
| Address |
Government Dental College and Hospital,Nagpur.
Medical campus, medical square, Nagpur 440003 |
| Type of Sponsor |
Other [Self Sponsor] |
|
|
Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Nikita Ravindra Baheti |
Government Dental College and Hospital, Nagpur |
101 PG section, Department of orthodontics, Government Dental College and Hospital, medical college premises, medical square, Nagpur- 440003 Nagpur MAHARASHTRA |
9422712340
nikita.baheti3@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethical committee,GDCH, Nagpur |
Approved |
|
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Regulatory Clearance Status from DCGI
|
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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 |
| Comparator Agent |
Twin Block appliance with Electronic timing device |
Wear time of Twin Block appliance placed inside the oral cavity close to prescribed wear time by Clark. Frequency of checking time of wearing appliance in mouth is per month for total duration of six months. |
| Intervention |
Twin Block with Electronic timing device |
Twin Block appliance placed inside the oral cavity is modified by placing electronic timing device within acrylic to assess wear time and wear time differs from prescribed wear time by Clark. Frequency of checking time of wearing appliance in mouth is per month for total duration of six months. |
|
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Inclusion Criteria
|
| Age From |
11.00 Year(s) |
| Age To |
14.00 Year(s) |
| Gender |
Both |
| Details |
Clinically:
1.No previous history of any orthodontic treatment.
2.Each subject with a full cusp class II or end-on molar relationship
bilaterally with convex facial profile.
3.The overjet should not be less than 5mm.
4.VTO improved with anterior positioning of mandible.
Radiographically:
1.ANB angle more than 4 degree with favorable functional analysis
and favorable growth pattern.
2.Subjects who are at accelerated phase of pubertal growth spurt
(CVMI stage-3, MP3-FG and MP3- G stage). |
|
| ExclusionCriteria |
| Details |
1) Class I due to TSALD (Tooth Size Arch Length Discrepancy)
2) Excess Lower anterior face height
3) Proclined mandibular incisors.
4) Nasal stenosis due to structural problems.
5) Non-growing individuals
6) Syndromic cases |
|
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Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The wear time affects/ does not affect treatment efficacy of twin block appliance |
6 months after Twin Block appliance delivery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The patient does/does not wear Twin Block appliance to recommended wear time |
Monthly till 6 months |
|
|
Target Sample Size
|
Total Sample Size="30" Sample Size from India="30"
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)
|
16/03/2020 |
| 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
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Class II malocclusion is one of the most prevalent orthodontic conditions throughout the world, and these deformities are mainly treated by using functional appliances in growing patients. The most popular myofunctional appliance used for correction of class II malocclusion is the versatile removable twin block appliance in growing patients. Twin block is designed for full time wear to take the advantage of all functional forces applied to dentition. The cooperation of children and adolescents plays a major role in achieving the desired treatment outcome with twin block appliance. Objective measurement of wear time has been demanded in orthodontics for a long time. In cases of failure or stagnating treatment it helps to find possible explanations. Studies show that patients sometimes are not very honest or unrealistic concerning their reported wear times. Therefore, different devices have been introduced to measure the objective wear time of removable appliances. Most of these devices consist of a thermal microsensor that is embedded in the appliances.4 But in the country like India where most of the time environmental temperature is more than mouth temperature, these thermal sensors will give a false result. So, need to design a low cost electronic timing device suitable for application in removable acrylic orthodontic appliances. In this study, pretested electronic timing device which uses sensor with a switch function to record wear time will be used. The aim of this study is to measure the wear time and to evaluate treatment efficacy in relation to wear time with twin block appliance. |