| CTRI Number |
CTRI/2024/04/065191 [Registered on: 04/04/2024] Trial Registered Prospectively |
| Last Modified On: |
26/03/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
This study aims to assess how well we can predict and control tooth movements with invisible aligner treatment. This includes checking how accurately these aligners can shift the teeth into desired position. |
|
Scientific Title of Study
|
Association between quantum of linear tooth movement and percentage accuracy in clear aligner therapy -
A Retrospective Cohort Evaluation. |
| 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. Chandani Shah |
| Designation |
PhD Scholar |
| Affiliation |
Manav Rachna International Institute of Research and Studies |
| Address |
Room no. 3, Department of Orthodontics and Dentofacial Orthopaedics, Manav Rachna Dental College, School of Dental Sciences, Manav Rachna International Institute of Research and Studies.
Faridabad
HARYANA
121004
India |
| Phone |
9930811742 |
| Fax |
|
| Email |
dr.chandanishah07@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Puneet Batra |
| Designation |
Principal, Professor and HOD |
| Affiliation |
Manav Rachna International Institute of Research and Studies. |
| Address |
Room no. 3, Department of Orthodontics and Dentofacial Orthopaedics, Manav Rachna Dental College, School of Dental Sciences, Manav Rachna International Institute of Research and Studies.
Faridabad
HARYANA
121004
India |
| Phone |
9810335961 |
| Fax |
|
| Email |
drpuneetbatra@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr. Chandani Shah |
| Designation |
PhD Scholar |
| Affiliation |
Manav Rachna International Institute of Research and Studies. |
| Address |
Room no. 3, Department of Orthodontics and Dentofacial Orthopaedics, Manav Rachna Dental College, School of Dental Sciences, Manav Rachna International Institute of Research and Studies.
Faridabad
HARYANA
121004
India |
| Phone |
9930811742 |
| Fax |
|
| Email |
dr.chandanishah07@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Chandani Shah |
| Address |
Room no. 3, Department of Orthodontics and Dentofacial Orthopaedics, Manav Rachna Dental College, School of Dental Sciences, Manav Rachna International Institute of Research and Studies. |
| 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 |
| Dr Chandani Shah |
Manav Rachna International Institute of Research and Studies. |
Room no. 3, Department of Orthodontics and Dentofacial Orthopaedics, Manav Rachna Dental College, School of Dental Sciences, Manav Rachna International Institute of Research and Studies.
Faridabad
HARYANA |
9930811742
dr.chandanishah07@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Manav Rachna Dental College |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K089||Disorder of teeth and supporting structures, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
32.00 Year(s) |
| Gender |
Both |
| Details |
Complete dentition
No supernumerary teeth
No tooth shape anomalies
Good oral hygiene with Healthy periodontium.
Minimum 20 Aligner sets have been worn with a mid treatment Intraoral scan done at 20th Aligner. |
|
| ExclusionCriteria |
| Details |
Tooth movement less than 0.1mm at the end of stage 20
Systemic pathologies
Tooth/Bone related disorders (root resorption)
Ongoing pharmacological treatment affecting orthodontic movement(e.g.bisphosphonates)
Active periodontal disease
Smokers |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
The mean accuracy of tooth movement with aligners is expected to range from 40% to 60%, comparing between predicted and actual achieved results for linear tooth movements.
The study would help establish the relationship between the quantum of tooth movement and the percentage accuracy of tooth movement. |
The teeth positions would be assessed at baseline and after 27 weeks. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Correlation between quantum of tooth movement and percentage accuracy of tooth movement of maxillary and mandibular anterior teeth. |
20 SETS OF ALIGNERS WORN 10 DAY EACH |
|
|
Target Sample Size
|
Total Sample Size="450"
Sample Size from India="450"
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)
|
31/05/2024 |
| 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="0"
Months="7"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
The retrospective cohort study primarily aims to evaluate and assess the predictability of clear aligners with respect to linear movements in all 3 planes of space. The study also aims to compare the digitally planned tooth movement and the tooth movement clinically achieved at 1st refinement stage. The study further aims to establish correlation between quantum of tooth movement and its percentage accuracy. 450 maxillary and mandibular anterior teeth (approximately 70 teeth in each set) treated using Flash aligner system would be retrospectively selected. Once the model preparation is completed, the pretreatment models would be digitally segmented for isolating individual tooth as separate objects. It would then be compared with unsegmented treatment plan models with Compare 8.1 software (GeoDigm). The following tooth movement (maxillary and mandibular anterior teeth) would be assessed and percentage accuracy would be calculated: Buccal and Lingual movement; Occlusal and Gingival movement; and Mesial and Distal movement. Data gathered would be assembled on a excel sheet and will be processed using appropriate statistical tests on Statistical package for Social Sciences (SPSS) software. Normality of numerical data would be assessed. The normality of data would decide the statistical tests. Considering the above parameters, the mean accuracy of tooth movement of clear aligners is expected to range from 40% to 60%, comparing between predicted and clinically achieved results for linear tooth movements in the current study. |