| CTRI Number |
CTRI/2018/04/013193 [Registered on: 12/04/2018] Trial Registered Retrospectively |
| Last Modified On: |
05/04/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparison Of Bone Thickness In Patients Treated With Special (Damon)Brackets and Normal(conventional) Brackets Using CBCT. |
|
Scientific Title of Study
|
Comparative Study To Evaluate Cortical Bone Thickness In Maxilla And Mandible Using CBCT In Patients Treated With Damon Self-Ligating And Conventional Brackets Systems In Non Extraction Cases-A Clinical Prospective Study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Kranthi Kiran Tatikonda |
| Designation |
Post Graduate |
| Affiliation |
Institute Of Dental Studies And Technologies (IDST) |
| Address |
NH-58, Delhi-Meerut Road.
Kadrabad Check Post,
Modinagar,Ghaziabad-201201.
Uttar Pradesh
Ghaziabad
UTTAR PRADESH
201201
India |
| Phone |
9410693868 |
| Fax |
|
| Email |
kranth6670@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Saurabh Sonar |
| Designation |
Professor |
| Affiliation |
Institute Of Dental Studies And Technologies (IDST) |
| Address |
NH-58, Delhi-Meerut Road.
Kadrabad Check Post,
Modinagar,Ghaziabad-201201.
Uttar Pradesh
Ghaziabad
UTTAR PRADESH
201201
India |
| Phone |
9810327188 |
| Fax |
|
| Email |
drsaurabhsonar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Kranthi Kiran Tatikonda |
| Designation |
Post Graduate |
| Affiliation |
Institute Of Dental Studies And Technologies (IDST) |
| Address |
NH-58, Delhi-Meerut Road.
Kadrabad Check Post,
Modinagar,Ghaziabad-201201.
Uttar Pradesh
Ghaziabad
UTTAR PRADESH
201201
India |
| Phone |
9410693868 |
| Fax |
|
| Email |
kranth6670@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr Kranthi Kiran Tatikonda
Post Graduate student, Department of Orthodontics, Institute of Dental studies and Technologies, Kadrabad, Modinagar 201201,Ghaziabad,UP |
|
|
Primary Sponsor
|
| Name |
Dr Kranthi Kiran Tatikonda |
| Address |
Department Of Orthodontics And Dentofacial Orthopedics, IDST,Delhi merut road NH-58, Modinagar 201201. UP |
| Type of Sponsor |
Other [] |
|
|
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 Kranthi Kiran Tatikonda |
Institute Of Dental Studies And Technologies |
Department of orthodontics and Dentofacial Orthopedics, Room No-4,Kadrabad Check post,Modinagar201201,UP
Ghaziabad
UTTAR PRADESH |
9410693868
kranth6670@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Of Dental Studies And Technologies |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Healthy, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Cortical Bone thickness in Maxilla and Mandible |
Compare Cortical bone thickness in Maxilla and Mandible by using CBCT |
| Intervention |
Damon Self-ligating and Conventional Brackets |
Comparative Study To Evaluate Cortical Bone Thickness In Maxilla And Mandible Using CBCT In Patients Treated With Damon Self-Ligating And Conventional Bracket System In Non-Extraction Cases-A Clinical Prospective Study. |
|
|
Inclusion Criteria
|
| Age From |
11.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Both |
| Details |
1)Skeletal and Dental Class I
2)Permanent Dentition
3)Non-Extraction
4)Moderate to Severe Crowding |
|
| ExclusionCriteria |
| Details |
1)Surgical Cases
2)Systemic and Medical Illness
3)Periodontally Compromised Dentition |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| relieving crowding |
1 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To Compare Cortical bone thickness post Treatment |
1.5 years |
|
|
Target Sample Size
|
Total Sample Size="16"
Sample Size from India="16"
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 4 |
|
Date of First Enrollment (India)
|
06/04/2017 |
| 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="5"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
none yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The study will comprise 16 patients seeking orthodontic treatment from the Department of Orthodontics divided into 2 groups comprising both Males and Females with Class I Molar relationship and Crowding, Group 1 Damon self ligating system, Group 2 Conventional Brackets 0.022 MBT system, CBCT (Cone Beam Computed Tomography) will be taken at the starting of the treatment and after completion of the treatment in both Maxilla and Mandible to measure the amount of cortical bone thickness before and after treatment in Damon self ligating and Conventional bracket systems in non extraction cases. . |