| 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
|
|
|
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
|
|
|
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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