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CTRI Number  CTRI/2025/03/082692 [Registered on: 19/03/2025] Trial Registered Prospectively
Last Modified On: 19/03/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Best Attachments for Clear Aligners - A Simple Guide to Improving Tooth Rotation 
Scientific Title of Study   Comparison of the efficacy of different attachments for precise rotation in clear aligner therapy 
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 Nikita Agarwal 
Designation  2nd year trainee post graduate 
Affiliation  SCB DENTAL COLLEGE,CUTTACK 
Address  At-Department of Orthodontics,SCB Dental College
At-Department of Orthodontics,SCB Dental College
Cuttack
ORISSA
753007
India 
Phone  08763777764  
Fax    
Email  nikki13792@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Suryakanta Das 
Designation  HOD Postgraduation Department Of Orthodontics 
Affiliation  SCB DENTAL COLLEGE,CUTTACK 
Address  AT-Department of Orthodontics,SCB DENTAL COLLEGE
AT-Department of Orthodontics,SCB DENTAL COLLEGE
Cuttack
ORISSA
753007
India 
Phone  9861099237  
Fax    
Email  orthosuryakantadas@gmail.com  
 
Details of Contact Person
Public Query
 
Name  DR SURYA KANTA DAS 
Designation  HOD POSTGRADUATION DEPARTMENT OF ORTHODONTICS 
Affiliation  SCB Dental College 
Address  AT-Department of Orthodontics,SCB DENTAL COLLEGE
AT-Department of Orthodontics,SCB DENTAL COLLEGE
Cuttack
ORISSA
753007
India 
Phone  9861099237  
Fax    
Email  orthosuryakantadas@gmail.com  
 
Source of Monetary or Material Support  
Department of Orthodontics,SCB Dental College,Cuttack,pin-753007,Odisha,India 
 
Primary Sponsor  
Name  Nikita Agarwal 
Address  Near Hitech Saloon, Friends Colony, CUTTACK,ODISHA,PIN-753001 
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 Nikita Agarwal  SCB Dental College  Department Of Orthodontics and Dentofacial Orthopedics ,Second floor Cuttack ORISSA
Cuttack
ORISSA 
8763777764

nikki13792@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  WITH NO SYMPTOM OF SYSTEMIC CONDITIONS WITH DENTOALVEOLAR MALOCCLUSION 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Group 1 rotated Maxillary Premolar with double attachments  rotated Maxillary Premolar with double attachments and a Palatal attachment on one side with a follow up of 7 DAYS 
Comparator Agent  GROUP 2 ROTATED MAXILLARY PREMOLAR WITH SINGLE ATTACHMENT  ROTATED MAXILLARY PREMOLAR WITH A LABIAL ATTACHMENT ON THE OPPOSITE SIDE WITH A FOLLOW UP OF 7 DAYS 
 
Inclusion Criteria  
Age From  19.00 Year(s)
Age To  25.00 Year(s)
Gender  Both 
Details  Patients with permanent dentition without any malformations of individual tooth
needing premolar derotation less than Forty five degree with mild dental discrepancy
Patients who have a non-extraction treatment plan without IPR
Subjects having Class-I skeletal pattern
Subjects with no prior Orthodontic Treatment
Subjects having no missing teeth
Patients with good control of oral hygiene and periodontal health 
 
ExclusionCriteria 
Details  1.Subjects with any systemic or syndromic conditions
2.Patients with restoration, wear, or trauma to teeth in the maxillary arch
3.The use of any auxiliaries, such as elastics or vibrational devices
4.Subjects having systemic illness or under long-term medication
5.Subjects having impacted teeth needing surgical exposures 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To assess and compare the efficacy o the maxillary premolar derotation with double attachment on one side and single attachment on the opposite side   on base line T0,after 5th week T5, After 10th week T10,After 15th week T15 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="20"
Sample Size from India="20" 
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   Phase 3 
Date of First Enrollment (India)   28/04/2025 
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="0"
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 goal of orthodontic treatment is to achieve optimal dental alignment and good occlusion. Fixed braces have traditionally been the main treatment option for correcting malpositioned teeth. However, patients now have a different choice that provides better aesthetic appeal and convenience because to the development of clear aligner therapy(CAT).

Clear aligners are custom-made, removable trays that gradually move the teeth into their desired positions by exerting gentle forces on the teeth through a series of aligners that are worn sequentially to correct the malocclusion.In fixed orthodontics the bracket and wire interact to bring about the desired tooth movement while in aligners desired tooth movement occurs as a consequence of predefined mismatch between the tooth and aligner coinciding with desired tooth movement . Aligners without any auxilaries have a number of limitations as they move the teeth into the available space away from centre of resistance.  Attachments are tooth-colored structures made of composite resin bonded to teeth increasing the area of contact and locating the point of force application closer to the centre of resistance allowing more bodily tooth   movement. As the use of aligners is limited, attachments are designed to improve the retention and movement of teeth.  

Attachment designs differ in their shape, size and placement to accommodate specific tooth movement3.  Despite the apparent improvements associated with attachment shapes, the absence of comprehensive research makes it 窗体底端

Attachment designs differ in their shape, size and placement to accommodate specific tooth movement.  Despite the apparent improvements associated with attachment shapes, the absence of comprehensive research makes it challenging to determine their relative efficacy for specific tooth movements.

 Aligners with attachments are used to carry out various tooth movements. Numerous studies and clinical assessments have examined the efficiency of attachments in carrying out different tooth movements. The efficiency of aligner is influenced by morphology of tooth due the interaction between the aligner and the teeth.  

                   Rotation correction of round shaped tooth is one of the least predictable movements in aligners and rotation correction of premolars is the least accurate . Derotation is carried by two methods: (1) Bonding attachments or other auxilaries to the buccal and palatal surfaces of the rotated tooth to create a couple  of force to correct it (2)using optimized  rotational attachments to derotate canines and premolars. These attachments are designed depending upon the force needed to derotate the tooth.  Additional aspects needed to be considered during derotation are overall amount of derotation, staging (degree of derotation per aligner), interproximal reduction [IPR], and the use of buttons with elastics.

One of the most common side effects of CAT is the unintended intrusion of the displaced tooth. This is known as ‘watermelon seed effect’ a phenomenon connected with aligners is used to measure intrusive force. These intrusive forces can be explained by local deformation of appliance’s inclined inner surface and decreased fit during increasing axial rotation which tends to raise the anterior surface, deforming the appliance like a bow.

As there are few evidence based studies carried out to evaluate the predictability of rotation with attachments in aligners as achieving the desired tooth movement is still a challenge. This study aims to compare the correction of  maxillary premolar derotation with double attachment on one side and single attachment on the opposite side with clear aligner therapy with a follow up of 7 days.The aligner changing protocol for all the patients will be one week, and they will be instructed to wear the aligners for 22 hours per day


 
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