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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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.

 
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