| CTRI Number |
CTRI/2024/12/078346 [Registered on: 19/12/2024] Trial Registered Prospectively |
| Last Modified On: |
17/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
Comparison of the effects of 2 different types of orthodontic brackets to correct irreguar lower front teeth |
|
Scientific Title of Study
|
Comparison of the effects of self ligating and conventional orthodontic appliances in the correction of mandibular anterior crowding in non extraction patients a prospective in vivo study |
| 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 SHREYA ELIZABETH JOHN |
| Designation |
MDS 1st year |
| Affiliation |
KVG Dental College and Hospital, Sullia |
| Address |
Room no.7 Department of Orthodontics and Dentofacial Orthopedics
KVG Dental College and Hospital Kurunjibhag Sullia Dakshina
kannada Karnataka 574327 India
Dakshina Kannada
KARNATAKA
574327
India |
| Phone |
8848976162 |
| Fax |
|
| Email |
johnshreya99@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR MAHESH KUMAR Y |
| Designation |
Professor |
| Affiliation |
KVG Dental College and Hospital, Sullia |
| Address |
Room No 7 Department of Orthodontics and Dentofacial Orthopedics
KVG Dental College and Hospital Kurunjibhag Sullia Dakshina Kannada Karnataka 574327 India
Dakshina Kannada
KARNATAKA
574327
India |
| Phone |
09448128842 |
| Fax |
|
| Email |
ymahesh2000@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
DR MAHESH KUMAR Y |
| Designation |
Professor |
| Affiliation |
KVG Dental College and Hospital, Sullia |
| Address |
Room No 7 Department of Orthodontics and Dentofacial Orthopedics
KVG Dental College and Hospital Kurunjibhag Sullia Dakshina Kannada Karnataka 574327 India
KARNATAKA
574327
India |
| Phone |
09448128842 |
| Fax |
|
| Email |
ymahesh2000@yahoo.com |
|
|
Source of Monetary or Material Support
|
| KVG Dental College and Hospital Kurunjibhag Sullia Dakshina Kannada Karnataka 574327 India |
|
|
Primary Sponsor
|
| Name |
DR SHREYA ELIZABETH JOHN |
| Address |
Room No 7 Department Of Orthodontics and Dentofacial Orthopedics KVG Dental College and Hospital Kurunjibhag Sullia Dakshina Kannada Karnataka 574327 India |
| 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 Shreya Elizabeth John |
KVG Dental College and Hospital |
room No 7 Department Of Orthodontics and Dentofacial Orthopedics KVG Dental College and Hospital Kurunjibhag Sullia Dakshina Kannada Karnataka 574327 India
Dakshina Kannada
KARNATAKA |
8848976162
johnshreya99@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee KVG Dental College and Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
NIL |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
CONVENTIONAL ORTHODONTIC BRACKETS |
As per the findings of Arezoo Jahanbin et al, more correction of the crowding
occurred with the self-ligating system over a 4-month alignment stage compared
with conventional MBT brackets. However, according to the findings of
Nikolaos Pandis et al, using conventional or self-ligating brackets had no effect
on time to alignment, mandibular intermolar or inter canine width.This study is proposed to be undertaken to compare the effects of self ligating and conventional orthodontic appliances in the correction of mandibular anterior
crowding in non extraction patients.A total time duration of 12 months is considered. |
| Intervention |
SELF LIGATING BRACKETS |
Self ligating brackets (SLB) enclose the bracket slot with an integrated system
because they work on the theory that removing ligating modules will reduce
friction and shorten treatment times. This study is proposed to be undertaken to compare the effects of self-ligating
and conventional orthodontic appliances in the correction of mandibular anterior
crowding in non extraction patients. A total time duration of 12 months is considered. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Both |
| Details |
Patients in the age group 18 to 30 years
Eruption of all mandibular teeth
No space in mandibular arch
Littles irregularity index of 1-3 mm- minimal crowding canine to canine.
Presence of all permanent teeth till 1st molars
Good oral hygiene
Non extraction treatment on mandibular arch |
|
| ExclusionCriteria |
| Details |
Carious teeth
Orthognathic surgery for skeletal discrepancy
Patients under medications- NSAIDs or other anti inflammatory patients
Hyperdontia or hypodontia
Severely crowded teeth
Cases requiring extraction of teeth
Mobility of teeth
Periodontally compromised teeth
Supernumerary teeth in the arch
Fractured teeth |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To compare the changes in mandibular intermolar, inter-canine distance and
the duration of correction of mandibular anterior crowding between conventional
and Self Ligating Brackets. |
1 month 2month 3month 5month
1 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To assess the changes in mandibular intermolar, inter-canine distance and
duration of correction of mandibular anterior crowding using conventional
brackets.
To assess the changes in mandibular intermolar, inter-canine distance and
duration of correction of mandibular anterior crowding using Self Ligating
Brackets. |
1month 2month 3month 5month 1 year |
|
|
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 2 |
|
Date of First Enrollment (India)
|
01/01/2025 |
| 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
|
Self-ligating brackets have been gaining popularity over the past several decades.
Various advantages for these systems have been claimed. Self-ligating appliances have also been demonstrated to offer a more dependable
ligation, more effective tooth movement, and better control over tooth rotation.Self-ligating brackets (SLB) enclose the bracket slot with an integrated system
because they work on the theory that removing ligating modules will reduce
friction and shorten treatment times. Passive and Active Self Ligating Appliances with a variety of ligating
mechanisms were introduced with their main goals to enable easy clinical
handling and allow for efficient sliding mechanics.
The major advantages of Self ligating brackets include increase in arch
expansion with less incisor proclination, faster ligation, fewer visits, less pain
and discomfort.
SL systems showed a quicker and more efficient wire removal and placement for late orthodontic treatment phases, as per the study by Sergio Paduano et al.
The study’s primary goal stems from the two opposing conclusions that two
distinct writers made in respective publications. As per the findings of Arezoo Jahanbin et al, more correction of the crowding
occurred with the self-ligating system over a 4-month alignment stage compared
with conventional MBT brackets. However, according to the findings of Nikolaos Pandis et al, using conventional or self-ligating brackets had no effect
on time to alignment, mandibular intermolar or inter canine width.This study is proposed to be undertaken to compare the effects of self-ligating
and conventional orthodontic appliances in the correction of mandibular anterior
crowding in non- extraction patients. |