CTRI Number |
CTRI/2020/06/025952 [Registered on: 17/06/2020] Trial Registered Prospectively |
Last Modified On: |
15/02/2022 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Dentistry |
Study Design |
Randomized, Parallel Group Trial |
Public Title of Study
|
Assessment of orthodontic tooth movement using bone screws |
Scientific Title of Study
|
Evaluation of Infra Zygomatic Crest Bone Screw aided En Masse Orthodontic Movement of Teeth : A Three Dimensional Clinical Study |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Hasini G |
Designation |
Post Graduate student |
Affiliation |
SCB Dental College And Hospital |
Address |
Post Graduate Department of Orthodontics & Dentofacial Orthopedics, SCB Dental College And Hospital, Mangalabag
Cuttack ORISSA 753007 India |
Phone |
9940386176 |
Fax |
|
Email |
hasinig94@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr Surya Kanta Das |
Designation |
Professor & Head of the Department |
Affiliation |
SCB Dental College And Hospital |
Address |
Post Graduate Department of Orthodontics & Dentofacial Orthopedics, SCB Dental College And Hospital, Mangalabag
Cuttack ORISSA 753007 India |
Phone |
9861099237 |
Fax |
|
Email |
orthosuryakantadas@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Hasini G |
Designation |
Post Graduate student |
Affiliation |
SCB Dental College And Hospital |
Address |
Post Graduate Department of Orthodontics & Dentofacial Orthopedics, SCB Dental College And Hospital, Mangalabag
Cuttack ORISSA 753007 India |
Phone |
9940386176 |
Fax |
|
Email |
hasinig94@gmail.com |
|
Source of Monetary or Material Support
|
SCB Dental college and hospital mangalabag cuttack 753007 odisha |
|
Primary Sponsor
|
Name |
Dr Hasini G |
Address |
Post Graduate Department of Orthodontics & Dentofacial Orthopedics, SCB Dental College And Hospital, Mangalabag, Cuttack, Orissa 753007 India |
Type of Sponsor |
Other [Post Graduate student] |
|
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 |
Hasini G |
SCB Dental College And Hospital |
Post Graduate Department of Orthodontics & Dentofacial Orthopedics, SCB Dental College And Hospital, Mangalabag 753007 India Cuttack ORISSA |
9940386176
hasinig94@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Institutional Ethics Committee, SCB Dental college and hospital |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition: M264||Malocclusion, unspecified, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Intervention |
Group I (12-18years) |
All the patients in the study will be treated with Pre- Adjusted Edgewise appliance system (MBT prescription, slot: 0.018 x 0.025 in).After alignment & levelling, Infrazygomatic bone screws of size (2x14mm) will be placed on both right and left sides.Records such as study models,photographs and CBCT maxilla are taken.Then retraction is done with 16 x 22 Stainless steel archwire. Patient will be recalled for follow up every 4weeks. Stability of the bone screw at the time of placement,soft tissue thickness at the site of placement and soft tissue response are assessed.The same records will be obtained after the completion of orthodontic retraction. |
Comparator Agent |
Group II (19-25years) |
All the patients in the study will be treated with Pre- Adjusted Edgewise appliance system (MBT prescription, slot: 0.018 x 0.025 in).After alignment & levelling, Infrazygomatic bone screws of size (2x14mm) will be placed on both right and left sides.Records such as study models,photographs and CBCT maxilla are taken.Then retraction is done with 16 x 22 Stainless steel archwire. Patient will be recalled for follow up every 4weeks. Stability of the bone screw at the time of placement,soft tissue thickness at the site of placement and soft tissue response are assessed.The same records will be obtained after the completion of orthodontic retraction. |
|
Inclusion Criteria
|
Age From |
12.00 Year(s) |
Age To |
25.00 Year(s) |
Gender |
Both |
Details |
cases requiring,
-en masse retraction (class II div I, class I bimaxilary protrusion )
patients with normal or average growth pattern.
|
|
ExclusionCriteria |
Details |
Medically compromised patients
long term corticosteroid therapy or other medication such as Bisphosphonates,
NSAIDs
Active periodontal disease.
Ankylosed teeth |
|
Method of Generating Random Sequence
|
Computer generated randomization |
Method of Concealment
|
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
Primary Outcome
|
Outcome |
TimePoints |
To evaluate and compare the stability and success rates of Infra zygomatic Crest bone screws between study groups. |
6months |
|
Secondary Outcome
|
Outcome |
TimePoints |
To evaluate the soft tissue response and intra bony and extra bony position of the Infra zygomatic Crest bone screws.
To evaluate and compare the en masse retraction of teeth in all three planes |
6 months |
|
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 1 |
Date of First Enrollment (India)
|
22/06/2020 |
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="0" Months="6" Days="0" |
Recruitment Status of Trial (Global)
|
Not Applicable |
Recruitment Status of Trial (India) |
Not Yet Recruiting |
Publication Details
Modification(s)
|
not yet |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
Orthodontic anchorage control is a fundamental part of treatment planning and subsequent treatment delivery. There are many different sources of orthodontic anchorage. The need to eliminate the adverse effects and to maximize the anchorage led to the development of Temporary Anchorage Devices (TADs) utilizing mini screws and mini plates.The infrazygomatic crest , a bony ridge running along the curvature between the alveolar and zygomatic processes of the maxilla is located between the first and second molars. Due to the relatively long distance from the root region, the risk of contact of an infrazygomatic implant with the natural tooth root is reduced thereby allowing an unobstructed tooth movement.Application of Cone Beam Computed Tomography (CBCT) in dentistry has given promising results in assessing the treatment outcomes in all the three planes as well as to visualize changes in three dimension. The purpose of the study is to evaluate the infra zygomatic crest implant aided enmasse movement of teeth.This prospective clinical study will be conducted in the Department Of Orthodontics And Dentofacial Orthopaedics, S C B Dental College And Hospital, Cuttack, Odisha, India.All the patients in the study will be treated with Pre- Adjusted Edgewise appliance system (MBT prescription, slot: 0.018 x 0.025 in).After alignment & levelling, Infrazygomatic bone screws of size (2x14mm) will be placed on both right and left sides.Records such as study models,photographs and CBCT maxilla are taken.Then retraction is done with 16 x 22’’ Stainless steel archwire. Patient will be recalled for follow up every 4weeks. Stability of the bone screw at the time of placement,soft tissue thickness at the site of placement and soft tissue response are assessed.The same records will be obtained after the completion of orthodontic retraction.Then the data will be subjected to statistical analysis using SPSS software. |