| CTRI Number |
CTRI/2019/05/019072 [Registered on: 13/05/2019] Trial Registered Prospectively |
| Last Modified On: |
10/05/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of tooth movement between techniques that use braces fixed in front surface of teeth and braces fixed on the back surface of teeth |
|
Scientific Title of Study
|
Three dimensional evaluation of Labial & Lingual orthodontic technique for en masse maxillary anterior teeth retraction using microimplant-lever arm mechanics - A Comparative clinical trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Abirami R |
| Designation |
Postgraduate student |
| Affiliation |
S.C.B Dental College & Hospital |
| Address |
Postgraduate Department of Orthodontics & dentofacial orthopedics, S.C.B Dental College & Hospital, Mangalabag, Cuttack.
Cuttack
ORISSA
753007
India |
| Phone |
7598187497 |
| Fax |
|
| Email |
abiramiortho@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Surya Kanta Das |
| Designation |
Professor and Head of the Department |
| Affiliation |
S.C.B Dental College & Hospital |
| Address |
Postgraduate department of Orthodontics & dentofacial orthopedics, S.C.B Dental College & Hospital, Managalabag, Cuttack.
Cuttack
ORISSA
753007
India |
| Phone |
9861099237 |
| Fax |
|
| Email |
orthosuryakantadas@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Abirami R |
| Designation |
Postgraduate Student |
| Affiliation |
S.C.B Dental College & Hospital |
| Address |
Postgraduate department of Orthodontics & dentofacial orthopedics, S.C.B Dental College & Hospital, Managalabag, Cuttack.
Cuttack
ORISSA
753007
India |
| Phone |
7598187497 |
| Fax |
|
| Email |
abiramiortho@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
DrAbirami R |
| Address |
Postgraduate department of Orthodontics & dentofacial orthopedics, S.C.B Dental College & Hospital, Managalabag, Cuttack. |
| Type of Sponsor |
Other [Self funded] |
|
|
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 Abirami R |
S.C.B Dental College & Hospital |
Postgraduate department of Orthodontics & dentofacial orthopedics, S.C.B Dental College & Hospital, Managalabag, Cuttack.
Cuttack
ORISSA |
7598187497
abiramiortho@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, SCB Dental College & Hospital, Cuttack, Odisha |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
malocclusion diagnosis of Angles Class I (bidentoalveolar protrusion) or Class II division 1 with the treatment plan of extraction of maxillary 1st premolars required with maximum anchorage |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Labial Orthodontic technique |
Enmasse retraction of maxillary anterior teeth with microimplant-lever arm mechanics in Pre-adjusted edgewise system (MBT presription)
Force delivery :250gm caliberated with Ni-Ti coil spring using dontrix gauge.
Frequency : every 30days |
| Intervention |
Lingual Orthodontic technique |
Enmasse retraction of maxillary anterior teeth with microimplant-lever arm mechanics in customised Lingual orthodontic technique.
Force delivery :250gm caliberated with Ni-Ti coil spring using dontrix gauge.
Frequency : every 30days |
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
33.00 Year(s) |
| Gender |
Both |
| Details |
Malocclusion diagnosis : Angle’s Class I bidentoalveolar protrusion/Class II division 1; Treatment plan : extraction of maxillary first premolars required with maximum anchorage for en-masse retraction of anterior teeth.
Normal growth pattern
No active periodontal lesions
Not under chronic medication like NSAIDs, steroids, bisphosphonates, etc., that alter bone metabolism.
No Craniofacial anomalies
|
|
| ExclusionCriteria |
| Details |
H/O Systemic illness.
H/O Previous orthodontic treatment
Missing teeth except for third molars
Presence of ankylosed teeth |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate and compare the position of maxillary anteriors in sagittal plane (Y-axis) between labial and lingual orthodontic technique with en-masse retraction. |
Pre retraction, Post-retraction |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To evaluate and compare the position of maxillary anteriors in vertical (Z-axis) & transverse plane (X-axis) between labial and lingual orthodontic technique with en-masse retraction.
To evaluate and compare rate of tooth movement & treatment duration between labial and lingual orthodontic technique with en-masse retraction. |
Pre-retraction, Post-retraction |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
20/05/2019 |
| 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="7"
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
|
Lingual Orthodontic technique, a novel innovation towards an aesthetic-focused approach, attracts the attention to be an unparalleled ideology as a complete truly invisible technique. In Premolar extraction cases, En-masse anterior teeth retraction is preferred over two-step retraction because of aesthetic and mechanical considerations. The Challenge posed during retraction may be attributed to the moment generated in the maxillary anteriors, making the torque control during retraction a tougher challenge in Lingual orthodontics than labial. The Efficient and most predictable way to effectively retract maxillary anteriors is by biomechanically optimizing the retraction force vector. Micro-implants, apart from anchorage reinforcement can help to optimize the force vector. The Micro-implant–Lever arm designs a mechanical plan based on Class-1 lever mechanics of Physics; can circumvent the limitations of adverse moment to force ratio and offer a goal oriented treatment planning. Though many clinical studies have been done to assess Micro-implant-Lever arm mechanics in labial orthodontics, information and researches on lingual orthodontics are still deficient and are fastened at the level of finite element analysis and few case reports. Thus clinical trials on this topic are needed to explore & record the method. |