| CTRI Number |
CTRI/2024/06/068705 [Registered on: 11/06/2024] Trial Registered Prospectively |
| Last Modified On: |
14/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A comparative study to evaluate the amount of intrusion and apical root resorption of upper front teeth using 3 different types of modalities. |
|
Scientific Title of Study
|
Evaluation of amount of true intrusion and apical root resorption of maxillary incisors using mini-screws, utility intrusion arch, and connecticut intrusion arch – A comparative study |
| 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 Aashutosh Chhabra |
| Designation |
Post Graduate Student |
| Affiliation |
Atal Bihari Vajpayee Medical University, Lucknow, Uttar Pradesh |
| Address |
Department of orthodontics and dentofacial orthopaedics, third floor, room no 1,
Inderprastha Dental College and Hospital, Shahibabad, Ghaziabad
Ghaziabad
UTTAR PRADESH
201010
India |
| Phone |
8950394255 |
| Fax |
|
| Email |
aashutoshchhabra@outlook.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rahul Paul |
| Designation |
Principal, Professor and HOD |
| Affiliation |
Inderprastha Dental College and Hospital, Shahibabad |
| Address |
Department of orthodontics and dentofacial orthopaedics, third floor, room no 1,
Inderprastha Dental College and Hospital, Shahibabad, Ghaziabad
Ghaziabad
UTTAR PRADESH
201010
India |
| Phone |
8950394255 |
| Fax |
|
| Email |
drrahulpaul@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Aashutosh Chhabra |
| Designation |
Post Graduate Student |
| Affiliation |
Inderprastha Dental College and Hospital, Shahibabad |
| Address |
Department of orthodontics and dentofacial orthopaedics, third floor, room no 1,
Inderprastha Dental College and Hospital, Shahibabad, Ghaziabad
Ghaziabad
UTTAR PRADESH
201010
India |
| Phone |
8950394255 |
| Fax |
|
| Email |
aashutoshchhabra@outlook.com |
|
|
Source of Monetary or Material Support
|
| Inderprastha Dental College and Hospital, Sahibabad, Ghaziabad, Uttar Pradesh, India, 201010 |
|
|
Primary Sponsor
|
| Name |
Dr Aashutosh Chhabra |
| Address |
Department of orthodontics and dentofacial orthopaedics, third floor, room no 1,
Inderpratsha Dental College and Hospital, Shahibabad, Ghaziabad, Uttar pradesh, India, 201010 |
| Type of Sponsor |
Other [Dr. Aashutosh Chhabra] |
|
|
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 Aashutosh Chhabra |
Inderprastha Dental College and Hospital |
Department of orthodontics and dentofacial orthopaedics, third floor, room no. 1
Ghaziabad
UTTAR PRADESH |
8950394255
aashutoshchhabra@outlook.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: K033||Pathological resorption of teeth, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Connecticut intrusion arch |
to check the difference in intrusion of maxillary cental incisors with other modalities, after 4 weeks |
| Intervention |
Mini Implants |
To check the difference in intrusion of maxillary cental incisors with other modalities, after 4 weeks |
| Comparator Agent |
Utility Intrusion Arch |
Controll for maxillary central incisors intrusion |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Both |
| Details |
Deep-bite more than 4mm,
Pseudo deep-bite cases,
Excessive gingival display in maxillary region,
Normal upper anterior facial height,
Normal angulation of upper incisors to nasal floor,
Patient with no root resorption,
Patient with good periodontal health. |
|
| ExclusionCriteria |
| Details |
Short upper lip after growth completion
Vertical maxillary excess
Proclined maxillary incisors
Deep-bite less than 4mm
True deep-bite
History of trauma
Prior root resorption
Cyst/tumors in maxillary anterior region
Periapical inflammation |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare and evaluate the amount of true intrusion and external apical root resorption achieved between mini-screws, utility arch and connecticut intrusion arch in the maxillary central incisors. |
T0- baseline
T1- 2 months
T2- 4 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare and evaluate the amount of true intrusion and external apical root resorption achieved between mini-screws, utility arch and connecticut intrusion arch in the maxillary central incisors in first 2 months with later 2 months |
FROM T0 to T1
FROM T1 to T2 |
|
|
Target Sample Size
|
Total Sample Size="45"
Sample Size from India="45"
Final Enrollment numbers achieved (Total)= "45"
Final Enrollment numbers achieved (India)="45" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
24/06/2024 |
| Date of Study Completion (India) |
03/03/2025 |
| Date of First Enrollment (Global) |
24/06/2024 |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - For individual participant data meta-analysis.
- By what mechanism will data be made available?
Response - Proposals should be directed to [aashutoshchhabra@outlook.com].
- For how long will this data be available start date provided 30-04-2025 and end date provided 01-11-2025?
Response (Others) - 30 april 2025- 1 nov 2025
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - N/A
|
Brief Summary
Modification(s)
|
|
AIM OF THE STUDY:
To
compare and evaluate the amount of true intrusion and external apical root
resorption achieved between mini-screws, utility arch and connecticut
intrusion arch in the maxillary central incisors.
OBJECTIVE OF THE STUDY:
§ To
evaluate the amount of intrusion in maxillary central incisors achieved with
mini-screws, utility intrusion arch and connecticut intrusion arch.
§ To
evaluate the amount of external apical root resorption in maxillary central
incisors caused by mini-screws, utility intrusion arch and connecticut
intrusion arch during intrusion.
§ To
compare the amount of intrusion in maxillary central incisors achieved with
mini-screws, utility intrusion arch and connecticut intrusion arch.
§ To
compare the amount of external apical root resorption in maxillary central
incisors caused by mini-screws, utility intrusion arch and connecticut
intrusion arch during intrusion.
NULL HYPOTHESIS:
The amount of intrusion is same with mini-screws,
utility intrusion arch and connecticut intrusion arch placed on the maxillary central incisors. The amount of external apical root resorption is same with mini-screws, utility intrusion arch and connecticut intrusion arch placed on the maxillary central incisors.
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