| 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
|
|
|
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
|
|
|
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.
|