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CTRI Number  CTRI/2024/04/066147 [Registered on: 23/04/2024] Trial Registered Prospectively
Last Modified On: 22/04/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Follow Up Study 
Study Design  Single Arm Study 
Public Title of Study   Evaluating Bite changes Using Computer Scan In Patients Undergoing Treatment For Irregularly Arranged Teeth 
Scientific Title of Study   Evaluation of Occlusal Parameters in Aligner therapy using Computerized Occlusal Analysis in the Pre and post aligner treatment and during Retention Period 
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 Purnima Kolli 
Designation  1ST MDS 
Affiliation  Vishnu Dental College,Bhimavaram 
Address  Room no-6, Department of orthodontics, second floor, Block-III, Vishnu dental College, Bhimavaram

West Godavari
ANDHRA PRADESH
534202
India 
Phone  7680875779  
Fax    
Email  purnima.k@vdc.edu.in  
 
Details of Contact Person
Scientific Query
 
Name  Dr C V Padma Priya  
Designation  Head Of The Deprtment 
Affiliation  Vishnu Dental College,Bhimavaram 
Address  Room no-6, Department of orthodontics, second floor, Block-III, Vishnu dental College, Bhimavaram

West Godavari
ANDHRA PRADESH
534202
India 
Phone  9440712238  
Fax    
Email  padmapriyacv@vdc.edu.in  
 
Details of Contact Person
Public Query
 
Name  Dr C V Padma Priya  
Designation  Head Of The Deprtment 
Affiliation  Vishnu Dental College,Bhimavaram 
Address  Room no-6, Department of orthodontics, second floor, Block-III, Vishnu dental College, Bhimavaram

West Godavari
ANDHRA PRADESH
534202
India 
Phone  9440712238  
Fax    
Email  padmapriyacv@vdc.edu.in  
 
Source of Monetary or Material Support  
Vishnu Dental College, Vishnupur, Bhimavaram - 534202 
 
Primary Sponsor  
Name  Dr. Purnima Kolli 
Address  Room no-6, Department of orthodontics, second floor, Block-III, Vishnu dental College, Bhimavaram -534202 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Purnima Kolli  Vishnu Dental College,Bhimavaram  Room no-6, Department of orthodontics, second floor, Block-III, Vishnu dental College, Bhimavaram
West Godavari
ANDHRA PRADESH 
7680875779

purnima.k@vdc.edu.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee,Vishnu Dental College  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K088||Other specified disorders of teethand supporting structures,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  N/A  N/A 
Comparator Agent  N/A  N/A 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  40.00 Year(s)
Gender  Female 
Details  1.Class I malocclusion with no missing teeth
2.Patients undergoing orthodontic treatment with clear aligners.
3.Fixed or wrap around retainers are provided during the retention period.
 
 
ExclusionCriteria 
Details  1.Individuals with cognitive or neurological alterations, with identified syndromes
2.Complex skeletal malocclusions
3.Periodontal compromised conditions
4.Patients with restorations and fixed prosthesis

 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To determine and compare % force distribution on right and left sides at maximum intercuspation at different time intervals
 
To determine and compare % force distribution on right and left sides at maximum intercuspation at different time intervals - Baseline, 8 to 12 months, 10 to 14 months,12 to 14 months,14 to 16 months.


 
 
Secondary Outcome  
Outcome  TimePoints 
To determine and compare occlusal parameters at different time intervals
1.Occlusion time in maximum intercuspation.
2.Disocclusion time from maximum intercuspation.
3. Location of initial contacts and no of contacts.
4.Sequential contacts from initial contact to maximum intercuspation 
To determine and compare % force distribution on right and left sides at maximum intercuspation at different time intervals - Baseline, 8 to 12 months, 10 to 14 months,12 to 14 months,14 to 16 months. 
 
Target Sample Size   Total Sample Size="12"
Sample Size from India="12" 
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)   06/05/2024 
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="1"
Months="6"
Days="1" 
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 primary goal of orthodontic treatment is to achieve a stable and functional occlusion with enhancement of esthetics. During orthodontic treatment, occlusal changes occur simultaneously with tooth movement, which can result in occlusal imbalance. For long-term stability of occlusion in orthodontics, achieving proper alignment and intercuspation is important by the end of treatment. Treatment for occlusal disharmonies often involves orthodontic interventions, occlusal adjustments, or other dental procedures aimed at restoring proper alignment and function of the bite. Disharmonies can occur in both fixed appliances, such as traditional braces, and aligners. These issues may arise from factors like misaligned brackets or poorly fitting aligners, which can result in discomfort or misalignment during orthodontic treatment. To detect occlusal disharmony, traditional methods like articulating paper have limitations, leading to the emergence of technologies like T-scan. T-scan digital system analysis measures precise quantitative and qualitative evaluation of occlusal forces and contacts. Using T-scan technology, we can measure a range of parameters including occlusion time, disocclusion time, contact points, and percentage force distribution at different time intervals. The purpose of this study is to determine occlusal contact qualities during the course of orthodontic treatment with aligners using T-scan.

Hence the present study is planned to evaluation of occlusal parameters in aligner therapy using computerized occlusal analysis in the pre and post aligner treatment and during retention period

 
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