| CTRI Number |
CTRI/2019/11/022039 [Registered on: 18/11/2019] Trial Registered Prospectively |
| Last Modified On: |
15/11/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Other |
|
Public Title of Study
|
Comparison of changes in tooth, root and bone in lower front teeth region between two appliances used for correction of jaw relation - a 3D image study |
|
Scientific Title of Study
|
Comparative assessment of tooth inclination, root resorption and cortical bone variation in mandibular anteriors between Advansync2 and Forsus appliances – a prospective CBCT study
|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Roopa K |
| Designation |
Post-graduate student |
| Affiliation |
KLE societys institute of dental sciences |
| Address |
KLE societys institute of dental sciences, Department of Orthodontics and dentofacial orthopaedics, Room no.7
No.22, Yeshwantpur suburb, Tumkur Main Road. Bangalore
Bangalore
Bangalore
KARNATAKA
560022
India |
| Phone |
8277418096 |
| Fax |
|
| Email |
roopa.murthy7@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Anup Belludi |
| Designation |
Professor |
| Affiliation |
KLE societys institute of dental sciences |
| Address |
KLE societys institute of dental sciences, Department of Orthodontics and dentofacial orthopaedics, Room no.7
No.22, Yeshwantpur suburb, Tumkur Main Road. Bangalore
Bangalore
Bangalore
KARNATAKA
560022
India |
| Phone |
9632629555 |
| Fax |
|
| Email |
dranupbelludi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Roopa K |
| Designation |
Post-graduate student |
| Affiliation |
KLE societys institute of dental sciences |
| Address |
KLE societys institute of dental sciences, Department of Orthodontics and dentofacial orthopaedics, Room no.7
No.22, Yeshwantpur suburb, Tumkur Main Road. Bangalore
Bangalore
Bangalore
KARNATAKA
560022
India |
| Phone |
8277418096 |
| Fax |
|
| Email |
roopa.murthy7@gmail.com |
|
|
Source of Monetary or Material Support
|
| Roopa K
Post-graduate student
Department of Orthodontics
KLE Societys institute of dental sciences, Bengaluru |
|
|
Primary Sponsor
|
| Name |
Roopa K |
| Address |
Department of Orthodontics and dentofacial orthopaedics Room no.
7 KLE Societys institute of dental sciences 22, Yeshwantpur suburb,
Tumkur Main Road. Bangalore 22 |
| Type of Sponsor |
Other [Self sponsored] |
|
|
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 |
| Roopa K |
KLE Societys Institute of Dental Sciences |
Department of
Orthodontics and
dentofacial
orthopaedics Room no.
7
No.22, Yeshwantpur
suburb, Tumkur Main
Road. Bangalore 22
Bangalore
KARNATAKA
Bangalore
KARNATAKA |
8277418096
roopa.murthy7@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: R688||Other general symptoms and signs, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
AdvanSync 2 appliance |
Appliance to correct molar relationship which is from upper molar on one side to lower molar on the same side. |
| Comparator Agent |
Forsus FRD appliance |
Appliance to correct molar relationship connected from upper molar to lower canine on same side. |
|
|
Inclusion Criteria
|
| Age From |
13.00 Year(s) |
| Age To |
20.00 Year(s) |
| Gender |
Both |
| Details |
1.Angle’s Class II malocclusion
2.13 to 20 years of age
3.Presence of fully erupted lower anterior teeth
4.No fracture and visible wear of lower incisal edges and canine tips
5.Good oral hygiene and periodontal status |
|
| ExclusionCriteria |
| Details |
1.Missing lower anteriors
2.Retained deciduous teeth
3.Dental pathology, malformations, carious lesions
4.Prosthesis on lower anteriors
5.History of previous orthodontic treatment |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Root resorption changes in milimeters, tooth
inclination changes in degrees and cortical bone
variation in milimetres. |
2 years |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Comparison of changes between AdvanSync 2 appliance and Forsus FRD appliance. |
2 years |
|
|
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)
|
05/12/2019 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
There are studies for assessment of tooth inclination, apical root resorption and cortical bone thickness after orthodontic treatment in general and in relation to functional appliance therapies using various radiographic modalities. But there is no study that compares the effects of AdvanSync therapy and Forsus appliance till date. Thus this study aims to evaluate the variations in tooth inclination, root length and cortical bone thickness in the mandibular anterior region in patients treated with AdvanSync and Forsus FRD with regards to accuracy provided by CBCT radiographic scanning technique. The ability of Cone Beam Computed Tomography (CBCT) to provide distortion-free slice images of single roots provides excellent possibilities to study root resorption. As a result of the advances in CBCT and software development, dental CBCT now also offers the additional possibility of determining the topographical location of the lower incisors. |