| CTRI Number |
CTRI/2021/10/037227 [Registered on: 11/10/2021] Trial Registered Prospectively |
| Last Modified On: |
08/09/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparing the efficiency of two different types of bracket system in correcting irregularly placed teeth without removal of teeth |
|
Scientific Title of Study
|
Comparative Evaluation of Changes In Incisor Position And Anchorage Loss With Self Ligating Brackets And Conventional Brackets In Non Extraction Cases – A Clinical Study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR A C Dechamma |
| Designation |
Post Graduate Student |
| Affiliation |
Coorg Institute of Dental Sciences |
| Address |
Room No:6,Department Of Orthodontics ,Coorg Institute Of Dental Sciences, KK Campus,Maggula,Virajpet ,Kodagu-571218, Karnataka,India
Kodagu
KARNATAKA
571218
India |
| Phone |
8105908512 |
| Fax |
|
| Email |
dechammaashik@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR Sanju Somaiah |
| Designation |
Professor |
| Affiliation |
Coorg Institute Of Dental Sciences |
| Address |
Room No:6,Department Of Orthodontics ,Coorg Institute Of Dental Sciences, KK Campus,Maggula,Virajpet ,Kodagu-571218, Karnataka,India
Kodagu
KARNATAKA
571218
India |
| Phone |
9945527999 |
| Fax |
|
| Email |
drsanjusomaiah@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
DR Sanju Somaiah |
| Designation |
PROFESSOR |
| Affiliation |
Coorg Institute Of Dental Sciences |
| Address |
Room No:6,Department Of Orthodontics ,Coorg Institute Of Dental Sciences, KK Campus,Maggula,Virajpet ,Kodagu-571218, Karnataka,India
Kodagu
KARNATAKA
571218
India |
| Phone |
9945527999 |
| Fax |
|
| Email |
drsanjusomaiah@yahoo.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
DR A C Dechamma |
| Address |
Room No:6,Department Of Orthodontics ,Coorg Institute Of Dental Sciences, KK Campus,Maggula,Virajpet ,Kodagu-571218, Karnataka,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 A C Dechamma |
Coorg Institute Of Dental Sciences |
Room No:6,Department Of Orthodontics ,Coorg Institute Of Dental Sciences, KK Campus,Maggula,Virajpet ,Kodagu-571218, Karnataka,India
Kodagu
KARNATAKA |
8105908512
dechammaashik@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| COORG INSTITUTE OF DENTAL SCIENCES |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K038||Other specified diseases of hard tissues of teeth, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Changes in incisor position and anchorage loss |
Comparison of changes in incisor position and anchorage loss in non extraction cases treated with Damon self ligating brackets and conventional brackets |
| Intervention |
Orthodontic correction of malocclusion using conventional brackets |
In group B malocclusion will be corrected by non extraction line of treatment using conventional brackets |
| Intervention |
Orthodontic correction of malocclusion using Damon self ligating brackets |
In group A malocclusion will be corrected by non extraction line of treatment using Damon self ligating brackets |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients with mild to moderate maxillary and mandibular dental arch crowding.
2.Male and female patients between the age group of 18 and 45 years.
3.Patients with no clinical signs of periodontal diseases.
4.Patients with no gingivitis or untreated caries.
5.Patients with no history of periodontal therapy.
|
|
| ExclusionCriteria |
| Details |
1.Previous history of any orthodontic or orthopedic treatment
2.Presence of supernumerary tooth or any congenital anomalies
3.Any bone pathology, ankylosed teeth.
4.Patients taking drugs modifying normal bone physiology (i.e., bisphosphonates) on or before a period of 3 months.
5.Patients with evidence of bone loss.
6.Patients who have undergone periodontal treatment within three months of baseline examination
7.Systemic disorder that could influence periodontal health.
|
|
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Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Assess the changes in incisor position and anchorage loss in non extraction cases treated with self ligating brackets.
2.Assess the changes in incisor position and anchorage loss in non extraction cases treated with conventional brackets. |
18 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Compare the changes in incisor position and anchorage loss in non extraction cases treated with self ligating brackets and conventional brackets. |
18 months |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
25/10/2021 |
| 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="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Anchorage plays a vital role in orthodontic treatment and anchorage planning helps in achieving stable treatment objectives. Anchorage loss is said to be a potential side effect from the orthodontic mechanotherapy and may lead to suboptimal results. The sliding mechanisms used in conventional brackets such as MBT develops frictional forces between arch wire and bracket and 60% of the applied force is dissipated as friction resulting in inhibited tooth movement thereby leading to anchorage loss. Self ligating brackets develop less frictional forces, use lighter forces and align the arch form by arch expansion. However alleviation of crowding in non-extraction cases treated with Damon self ligating brackets is associated with significant changes in the maxillary and mandibular incisor positions and anchorage loss. Only fewer studies have been conducted comparing the changes in incisor position in non-extraction cases treated with Damon self ligating and Conventional MBT brackets. Therefore the present study will be conducted to assess and compare the changes in incisor position, amount of anchorage loss and intensity of pain experienced by the patients in non-extraction orthodontic cases treated with Damon Q self ligating brackets and Conventional MBT Brackets. Anchorage plays a vital role in orthodontic treatment and anchorage planning helps in achieving stable treatment objectives. Anchorage loss is said to be a potential side effect from the orthodontic mechanotherapy and may lead to suboptimal results. The sliding mechanisms used in conventional brackets such as MBT develops frictional forces between arch wire and bracket and 60% of the applied force is dissipated as friction resulting in inhibited tooth movement thereby leading to anchorage loss. Hence the need for the present study is to 1. To assess the changes in incisor position with self ligating brackets and conventional brackets in non-extraction cases 2. To assess the amount of anchorage loss with self ligating brackets and conventional brackets in non-extraction cases 3. To assess the intensity of pain experienced by the patients with self ligating brackets and conventional brackets in non-extraction cases 4. To compare the changes in incisor position, amount of anchorage loss and intensity of pain experienced between self ligating brackets and conventional brackets in non-extraction cases 5. To draw clinical inferences from the above |