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CTRI Number  CTRI/2024/08/072282 [Registered on: 09/08/2024] Trial Registered Prospectively
Last Modified On: 05/08/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Single Arm Study 
Public Title of Study   Success rate of IZCs  
Scientific Title of Study   Evaluation of Bone quality, Insertion angle and Maxillary sinus proximity for success and long-term stability of IZCs: A CBCT-Based Clinical Trial  
Trial Acronym  nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Alisha 
Designation  PG 2nd year student 
Affiliation  Subharti dental college 
Address  Room no.7 2nd floor department of orthodontics and dentofacial orthopaedics, subharti dental college, Subhartipuram, Meerut

Meerut
UTTAR PRADESH
250005
India 
Phone  9588787671  
Fax    
Email  alishabansal464@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr. Pradeep Raghav 
Designation  HOD and Professor, Department of Orthodontics and Dentofacial Orthopaedics 
Affiliation  Subharti dental college 
Address  Room no.7 2nd floor department of orthodontics and dentofacial orthopaedics, subharti dental college, Subhartipuram, Meerut

Meerut
UTTAR PRADESH
250005
India 
Phone  9837175914  
Fax    
Email  drpradeepraghav@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Alisha 
Designation  PG 2nd year student 
Affiliation  Subharti dental college 
Address  Room no.7 2nd floor department of orthodontics and dentofacial orthopaedics, subharti dental college, Subhartipuram, Meerut


UTTAR PRADESH
250005
India 
Phone  9588787671  
Fax    
Email  alishabansal464@gmail.com  
 
Source of Monetary or Material Support  
Room no.7 2nd floor department of orthodontics and dentofacial orthopaedics, subharti dental college, Subhartipuram, Meerut, 250005, India 
 
Primary Sponsor  
Name  Alisha 
Address  Subharti dental college, Subhartipuram, Meerut-250005,India 
Type of Sponsor  Other [Subharti dental college, Subhartipuram, Meerut-250005,India] 
 
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 
Dr Alisha  Subharti dental college and Hospital  Room no. 7, 2nd floor, Department of orthodontics and dentofacial orthopaedics, Subharti dental college, Subhartipuram, Meerut
Meerut
UTTAR PRADESH 
9588787671

alishabansal464@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
university ethics committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  adequate bone quantity at infrazygomatic crest region 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Infra zygomatic screw  It is a skeletal anchorage device which is inserted in infrazygomatic crest region to get absolute anchorage for fixed orthodontic mechanotherapy. 
Comparator Agent  not applicable  not applicable 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  30.00 Year(s)
Gender  Both 
Details  1.Patients with all erupted permanent maxillary permanent teeth (except third molars).
2.No systemic conditions or bone related pathologies.
3.No history of medication altering bone properties.
4.No radiographic signs of periodontal disease.
5.No severe crowding in the posterior arch.
6.No craniofacial anomaly.
 
 
ExclusionCriteria 
Details  1.Non-compliant patient, inability to maintain proper oral hygiene.
2.Patients undergone previous orthodontic treatment.
3.Mentally challenged patients
4.Subjects with any known systemic or endocrinological disorder
 
 
Method of Generating Random Sequence    
Method of Concealment    
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
stabilization of IZCs  Adequate bone quality, insertion angle 
 
Secondary Outcome  
Outcome  TimePoints 
Perforation of maxillary sinus  Penetration depth in to sinus 
 
Target Sample Size   Total Sample Size="15"
Sample Size from India="15" 
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 3/ Phase 4 
Date of First Enrollment (India)   16/08/2024 
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="8"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

 

An estimated 38% to 50% of patients in modern orthodontic practise have class II malocclusion, making it one of the most prevalent types of malocclusion. Class ll malocclusions can be skeletal, due to maxillary prognathism or mandibular retrognathism, as well as dentoalveolar due to maxillary upper teeth proclination or lower teeth retroclination. There are many clinically proven, effective therapeutic options for treating Class II malocclusion, including headgear, functional orthopaedic appliances, mandibular protraction, conventional fixed appliances with intermaxillary elastics, and a combination of these mechanics with tooth extractions. However, each of these options requires a significant amount of patient cooperation to achieve its true objectives. 

To overcome the factor of patient compliance, TADs were introduced which provide absolute anchorage.

Orthodontic Mini-screws (TADs – temporary anchorage devices) are often used for anchorage in various movements like distalization, retraction, or intrusion.

Various anatomical sites which are present for miniscrew insertion includes palate, infra zygomatic crest, retromolar area and buccal alveolar process of maxilla and mandible.

 Placement of miniscrews in the buccal interradicular region is one of the most common approaches used for distal tooth movement. Although the interradicular miniscrews may reduce complications related to soft tissue irritation, the limited interradicular space can obstruct tooth movement. Therefore, now-a-days, the IZCs (infrazygomatic crest screws) are more well used as they don’t interfere the path of  tooth movement due to their extra alveolar placement. These extra alveolar TADs  have anatomic advantages of the infrazygomatic crest region i.e. thick cortical bone  which contribute to better primary stability of miniscrews and provide the possibility for unobstructed tooth movement.

IZC is a bony crest in the maxilla extending from the buccal plate of the alveolar process. It runs lateral to the roots of the first and second maxillary molars and extends 2cms or more to the zygomaticomaxillary suture, superiorly. Clinically it is a palpable ridge running along the curvature between the alveolar and zygomatic process of the maxilla. However, the location of this crest of the cortical bone is said to vary among young and old subjects. In young subjects, it is said to be located between the maxillary second premolar and first molar and in adults, it is above the maxillary first molar.

The anatomic limits, biomechanical perspectives, and the side effects are of prime considerations to master this technique but because a lot of controversies exist in the literature specifically regarding the placement, clinical efficiency and failure rates of mini-implants placed in the IZC region.

The factors associated with the failure rate of IZCs are still unclear. Hardly any CBCT studies have been done to assess the rate and reasons for failure of IZCs.  Hence, the objective of this study is to do the evidence based clinical trial for evaluating the efficacy and efficiency as well as the factors responsible for failure of IZCs as orthodontic implants. Aim is to evaluate the bone quality, insertion angle, and proximity to maxillary sinus on the survival rates of infrazygomatic crest miniscrews by 3-dimensional(3D) CBCT images.


 
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