| CTRI Number |
CTRI/2024/05/066961 [Registered on: 07/05/2024] Trial Registered Prospectively |
| Last Modified On: |
09/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study to measure the tooth size changes among the patients undergoing tooth correction with two different materials |
|
Scientific Title of Study
|
A Comparitive Volumetric Evaluation of Apical Root Resortion between Thermoformed and Direct printed aligners- A Prospective Controlled Clinical Trail |
| 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 Koramati Harsha Raj |
| Designation |
Ist year post graduate |
| Affiliation |
Vishnu Dental College |
| Address |
Room no 6,Block III,Department of Orthodontics and Dentofacial Orthopaedics, Vishnu Dental College,Bhimavaram
West Godavari
ANDHRA PRADESH
534202
India |
| Phone |
9010593790 |
| Fax |
|
| Email |
harsha.k@vdc.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr M Anoosha |
| Designation |
Reader(Mds) |
| Affiliation |
Vishnu Dental College |
| Address |
Room no 6,Block III ,Department of Orthodontics and Dentofacial Orthopaedics, Vishnu Dental College,Vishnupur, Bhimavaram
West Godavari
ANDHRA PRADESH
534202
India |
| Phone |
7674926249 |
| Fax |
|
| Email |
anoosha.m@vdc.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr M Anoosha |
| Designation |
Reader(Mds) |
| Affiliation |
Vishnu Dental College |
| Address |
Room no 6,Block III ,Department of Orthodontics and Dentofacial Orthopaedics, Vishnu Dental College,Vishnupur, Bhimavaram
West Godavari
ANDHRA PRADESH
534202
India |
| Phone |
7674926249 |
| Fax |
|
| Email |
anoosha.m@vdc.edu.in |
|
|
Source of Monetary or Material Support
|
| Vishnu Dental College, Vishnupur,Bhimavaram 534202 |
|
|
Primary Sponsor
|
| Name |
Dr K. Harsha Raj |
| Address |
Room no 6,Block III,Department of Orthodontics and Dentofacial Orthopaedics, Vishnu Dental College,Bhimavaram -534202 |
| 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 K Harsha Raj |
Vishnu Dental College |
Room no 6, Block no III ,Department of Orthodontics and Dentofacial Orthopaedics, Vishnu Dental College,Bhimavaram -534202
West Godavari
ANDHRA PRADESH |
9010593790
harsha.k@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: K033||Pathological resorption of teeth, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Direct printed aligners |
Direct printed aligners of 0.5mm thickness for the correction of mild to moderate crowding for 6 months |
| Comparator Agent |
Thermoformed Aligners |
thermoformed aligners of 0.5mm thickness for the correction of mild to moderate crowding for 6 months |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Both |
| Details |
1. Angles Class I and Class II malocclusion with mild to moderate crowding
2. Non-extraction treatment
3. Non-growing patients |
|
| ExclusionCriteria |
| Details |
1.Patients with previous maxillary incisor root canal treatment, history of trauma or missing teeth
2.Previous early interceptive or comprehensive orthodontic treatment
3.Systemic diseases
4. Loss of periodontal attachment
5.Evidence of prior inflammatory root resorption
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Apical Root Resorption |
Apical Root Resorption will be measured at baseline, 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="22"
Sample Size from India="22"
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="2"
Months="1"
Days="30" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
: In this study, a sample of 22 patients (88 incisors ) fulfilling the inclusion criteria are considered and they are divided into two groups thermoformed aligner patients and direct printed aligner patients..Pre-CBCT is taken at the initial appointment and after 6 months and then root volume is measured using software. The difference in the root volume gives the amount of Root resorption between the groups. |