| 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
|
|
|
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
|
|
|
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 |