| CTRI Number |
CTRI/2019/08/020709 [Registered on: 14/08/2019] Trial Registered Prospectively |
| Last Modified On: |
11/08/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A study comparing intraoral elastics and nickel titanium springs with respect to effect on orthodontic implant stability |
|
Scientific Title of Study
|
Comparative evaluation of E-chain and NiTi closed coil spring on micro implant stability – a randomised control trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Darshan Mathew Yuhan |
| Designation |
MDS student |
| Affiliation |
Manipal College of Dental Sciences, Mangalore |
| Address |
Department of Orthodontics and Dentofacial Orthopaedics, MCODS, Mangalore
Dakshina Kannada
KARNATAKA
575001
India |
| Phone |
9745047987 |
| Fax |
|
| Email |
darshan.m.y@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Darshan Mathew Yuhan |
| Designation |
MDS student |
| Affiliation |
Manipal College of Dental Sciences, Mangalore |
| Address |
Department of Orthodontics and Dentofacial Orthopaedics, MCODS, Mangalore
KARNATAKA
575001
India |
| Phone |
9745047987 |
| Fax |
|
| Email |
darshan.m.y@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Darshan Mathew Yuhan |
| Designation |
MDS student |
| Affiliation |
Manipal College of Dental Sciences, Mangalore |
| Address |
Department of Orthodontics and Dentofacial Orthopaedics, MCODS, Mangalore
KARNATAKA
575001
India |
| Phone |
9745047987 |
| Fax |
|
| Email |
darshan.m.y@gmail.com |
|
|
Source of Monetary or Material Support
|
| Manipal College of Dental Sciences Mangalore, Mangalore |
|
|
Primary Sponsor
|
| Name |
Department of Orthodontics and Dentofacial Orthopaedics |
| Address |
Manipal College of Dental Sciences Mangalore, Mangalore |
| Type of Sponsor |
Other [Private Dental College] |
|
|
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 |
| DrSiddarth Shetty |
Manipal College of Dental Sciences Mangalore |
Room number 6, Department of Orthodontics and Dentofacial Orthopaedics
Dakshina Kannada
KARNATAKA |
9980044933
siddarth.shetty@manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Manipal College of Dental Sciences, Mangalore |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Dental Malocclusions |
| Patients |
(1) ICD-10 Condition: K089||Disorder of teeth and supporting structures, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
E-chain (3M AlastiK grey colour coded CK 406-621)
NiTi coil spring (Sentalloy coil spring, Blue colour coded, 10-000-03) |
The study will be conducted as a split mouth technique on the maxillary arch. On one side the orthodontic force will be given using an elastomeric chain and on the other side using nickel titanium coil spring. For an elastomeric chain a good percentage of the initial force is lost over the first 24 hours and then continues to decrease at a much slower rate. With nickel titanium coil springs the loss of force over time is less compared to elastomeric chains |
| Comparator Agent |
NA |
NA |
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
20.00 Year(s) |
| Gender |
Both |
| Details |
Patient requiring fixed orthodontic treatment on both the arches
No history of periodontal disease
No history of previous orthodontic treatment
No history of any systemic conditions |
|
| ExclusionCriteria |
| Details |
Patient who has undergone orthodontic treatment previously
Presence of periodontal condition and bone loss
History of systemic conditions |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Implant stability |
1,2,3 and 4 months after implant placement |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess the likely impact of peri implant inflammation on implant stability given the difference in the above two groups |
1,2,3 and 4 months after implant placement |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
01/10/2019 |
| 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="0"
Months="10"
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)?
|
|
Brief Summary
|
Elastomeric chain and coil spring both exert lateral force on the implant, but the force given with elastomeric chain is intermittent and the force derived through a nickel titanium coil spring is continuous. This study investigates the stability of the implant when used with elastomeric chain on one side and coil spring on the other side. |