| CTRI Number |
CTRI/2024/05/067144 [Registered on: 10/05/2024] Trial Registered Prospectively |
| Last Modified On: |
08/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Evaluating Bone Quality by using X-ray Imaging technique and software models for the placement of mini screws in upper jaw |
|
Scientific Title of Study
|
Evaluating Bone Quality for Optimizing the Interradicular Mini Implant Placement in Maxilla: A Comparative Study Utilizing Cone Beam Computed Tomography And Digital Models |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Mohammad Ameena Mehanaz Ali |
| Designation |
First year Post Graduate |
| Affiliation |
Vishnu Dental College |
| Address |
Room number 6, Second floor, Department of Orthodontics, block III, Vishnupur, Bhimavaram
West Godavari
ANDHRA PRADESH
534202
India |
| Phone |
7780699601 |
| Fax |
|
| Email |
ameena.m@vdc.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr D Praveen kumar Varma |
| Designation |
Professor |
| Affiliation |
Vishnu Dental College |
| Address |
Room number 6, Second floor, Department of Orthodontics, block III, Vishnupur, Bhimavaram
West Godavari
ANDHRA PRADESH
534202
India |
| Phone |
9701457533 |
| Fax |
|
| Email |
dpkvarma@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr D Praveen kumar Varma |
| Designation |
Professor |
| Affiliation |
Vishnu Dental College |
| Address |
Room number 6, Second floor, Department of Orthodontics, block III, Vishnupur, Bhimavaram
West Godavari
ANDHRA PRADESH
534202
India |
| Phone |
9701457533 |
| Fax |
|
| Email |
dpkvarma@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Vishnu Dental College, Vishnupur,
Bhimavaram ,West Godavari district ,Andhra pradesh , Pincode: 534202. |
|
|
Primary Sponsor
|
| Name |
Dr Mohammad Ameena Mehanaz Ali |
| Address |
Room no 6,block III, Vishnu Dental College, Bhimavaram, West Godavari ,Andhra Pradesh. |
| Type of Sponsor |
Other [Self] |
|
|
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 Mohammad Ameena Mehanaz Ali |
Vishnu Dental College |
Room number 6, Second floor, Department of Orthodontics, block III, Vishnupur, Bhimavaram
West Godavari
ANDHRA PRADESH |
7780699601
ameena.m@vdc.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Vishnu Dental College |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K088||Other specified disorders of teethand supporting structures, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Day(s) |
| Age To |
40.00 Day(s) |
| Gender |
Both |
| Details |
1.Patients requiring Maximum anchorage
2.Patients requiring intrusion of maxillary anterior teeth.
3.Patients who are able to give informed consent
4.Patients who will undergo premolar extraction for orthodontic procedures
5.Complete eruption of permeant dentition with or without 3rd molars. |
|
| ExclusionCriteria |
| Details |
1.Periodontally compromised patients
2.Patients with missing maxillary molars.
3.Patients below age of 18.
4.Patients with any systemic diseases like Diabetes mellitus, bone disorders.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Buccal Alveolar Bone thickness and interradicular bone distance |
Buccal Alveolar Bone thickness and interradicular bone distance -Baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| labio palatal bone thickness and bone density |
labio palatal bone thickness and bone density-baseline |
|
|
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)
|
20/05/2024 |
| 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="1"
Months="6"
Days="1" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
40 patients
visiting for orthodontic treatment requiring inter
radicular mini implant screw placement
in the upper jaw in between both front and back teeth of the upper jaw and who are able to give informed consent will
be taken into consideration for this study. In dentistry Cone-beam computed
tomography (CBCT) has become widely used as it provides accurate information. (CBCT) is an advanced 3D radiographical imaging/x-ray that helps in
identifying the bone quality better than compared to 2D x-rays. This CBCT scan
data of 40 patients will be obtained after the radiographical scan is taken
with patients consent. After this, Intra
oral scanning of the upper jaw of the same 40 patients will be taken with an
intra oral scanning device with patients consent. The intra oral scan data is
used to create a virtual model in the computer called Digital model that
resembles the teeth and soft tissue of the upper jaw will be obtained from the
maestro 3D software. Evaluation of the bone quality will be done using OnDemand
software in the data of CBCT scan CBCT data of 40 patients will be collected
with patients consent. In CBCT using the OnDemand software measurements will be
done to asses the quality of bone. Digital models will be obtained by using
Maestro 3D from the intraoral scanned data of the patients. |