| CTRI Number |
CTRI/2026/02/102778 [Registered on: 02/02/2026] Trial Registered Prospectively |
| Last Modified On: |
31/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Other |
|
Public Title of Study
|
distalization in adult class II malocclusion |
|
Scientific Title of Study
|
comparision of clinical and cephalometric outcomes with ricketts z-sectional arch and infrazygomatic crest bone screw used in correction of adult class II malocclusion |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Rutvi Bharatbhai Karia |
| Designation |
post graduate student |
| Affiliation |
rural dental college |
| Address |
302, department of orthodontics and dentofacial orthopaedics
Pravara medical trust, Loni
MAHARASHTRA
413736
India |
| Phone |
9904494962 |
| Fax |
|
| Email |
kariarutvi@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Sumeet Mishra |
| Designation |
Associate professor |
| Affiliation |
rural dental college |
| Address |
302, department of orthodontics and dentofacial orthopaedics
Pravara medical trust, Loni
Ahmadnagar
MAHARASHTRA
413736
India |
| Phone |
9904494962 |
| Fax |
|
| Email |
drsumeetmishra@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Rutvi Bharatbhai Karia |
| Designation |
post graduate student |
| Affiliation |
rural dental college |
| Address |
302, department of orthodontics and dentofacial orthopaedics
Pravara medical trust, Loni
Ahmadnagar
MAHARASHTRA
413736
India |
| Phone |
9904494962 |
| Fax |
|
| Email |
kariarutvi@gmail.com |
|
|
Source of Monetary or Material Support
|
| rural dental college, pravara institute of medical science, Loni, Maharashtra, India 413736 |
|
|
Primary Sponsor
|
| Name |
NIL |
| Address |
NIL |
| 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 Rutvi Bharatbhai Karia |
rural dental college |
302, department of orthodontics, pravara institute of medical sciences
Ahmadnagar
MAHARASHTRA |
09904494962
kariarutvi@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| pravara institute of medical sciences |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
dental malocclusion |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
32.00 Year(s) |
| Gender |
Both |
| Details |
class II malocclusion, no growth spurt left, dental malocclusion |
|
| ExclusionCriteria |
| Details |
completion of growth phase and no congenital deformities |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| both groups achieved the needed distalization of maxillary segments |
5-8 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| some amount of proclination of teeth |
5-8 months |
| distalization |
5-8 months |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
17/02/2026 |
| 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="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
|
this study will be done to evaluate and compare the efficacy of both appliances in producing maxillary arch distalization and which appliance could be found to be more efficient. both the appliances will be evaluated for the time taken and efficiency of their result and compared |