| CTRI Number |
CTRI/2023/11/059446 [Registered on: 02/11/2023] Trial Registered Prospectively |
| Last Modified On: |
22/10/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effectiveness of interarch elastics vs occlusal turbos in the treatment of skeletal class 2 malocclusion in growing patients.
|
|
Scientific Title of Study
|
Efficacy of intermaxillary elastics vs functional bite turbos in the treatment of skeletal class 2 malocclusion in growing patients: an experimental 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 Yash Goenka |
| Designation |
2nd year post graduate student |
| Affiliation |
PRAVARA INSTITUTE OF MEDICAL SCIENCES LONI |
| Address |
Pravara institute of medical sciences loni, district
Ahmadnagar opd no 302 department of orthodontics pg
Section
Ahmadnagar
Maharashtra
413736
India
loni
rural dental college loni Ahmadnagar MAHARASHTRA 413736 India |
| Phone |
8805555371 |
| Fax |
|
| Email |
18yashgoenka@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Nandlal Toshniwal |
| Designation |
Mds Orthodontics |
| Affiliation |
PRAVARA INSTITUTE OF MEDICAL SCIENCES LONI |
| Address |
Pravara institute of medical sciences loni, district
Ahmadnagar opd no 302 department of orthodontics pg
Section
Ahmadnagar
Maharashtra
413736
India
Ahmadnagar MAHARASHTRA 413736 India |
| Phone |
9822353228 |
| Fax |
|
| Email |
drngtoshniwal@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Yash goenka |
| Designation |
2nd year Post Graduate student |
| Affiliation |
PRAVARA INSTITUTE OF MEDICAL SCIENCES LONI |
| Address |
Pravara institute of medical sciences loni, district
Ahmadnagar opd no 302 department of orthodontics pg
Section
Ahmadnagar
Maharashtra
413736
India
Ahmadnagar MAHARASHTRA 413736 India |
| Phone |
8805555371 |
| Fax |
|
| Email |
18yashgoenka@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
PRAVARA INSTITUTE OF MEDICAL SCIENCES LONI DISTRICT AHMADNAGAR |
| Address |
Pravara institute of medical sciences loni district
Ahmadnagar opd no 302 department of orthodontics pg
Section
Ahmadnagar
Maharashtra
413736
India
|
| 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 |
| Dr Yash Goenka |
Rural dental college |
opd no 302 department of orthodontics pg
Section
Ahmadnagar
Maharashtra
413736
India
Ahmadnagar MAHARASHTRA |
8805555371
18yashgoenka@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICAL COMMITTEE Pravara institute odf Medical Sciences Deemed University(IECPIMS-DU) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K039||Disease of hard tissues of teeth,unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
FUNCTIONAL BITE TRBOS |
MBT (Mclaughlin Bennet Trevesi) kit of metal brackets- mini 2000, having 0.022 slot manufactured by Ormco were used for the study. Upper and lower arches were bonded
with the help of light cure adhesive, namely Enlight. Performed molar bands were used. Ni-ti (Nickel Titanium) archwires were used for the initial alignment and leveling followed by stainless steel archwires.
Mini Bite Occlusal Turbos are bonded on the occlusal surface of premolars of both arches with inclination of 45 degree with Class II elastic supportive force .
|
| Comparator Agent |
Intermaxillary Elastics |
MBT (Mclaughlin Bennet Trevesi) kit of metal brackets, having 0.022 slot prescription manufactured by American orthodontics were used for the study. Upper and lower arches were bonded.
with the help of light cure adhesive, namely Enlight. Performed molar bands were used. Ni-ti (Nickel Titanium) archwires were used for the initial alignment and leveling followed by stainless steel archwires.
Elastics are routinely used as a active component of orthodontic therapy. Elastics have been a valuable adjunct of any orthodontic treatment for many years. There use, combined with good patient cooperation, provides the clinician with the ability to correct both Antero-posterior and vertical discrepancies.
Elastic force is used to apply a backward traction on the upper arch plane and forward traction of lower arch plane. It is secured from the lower molar tube hooks to the hook on the maxillary canine bracket.
In the beginning 1/2 inch of elastic are used with 8 ounce of force for few weeks which is followed by 5/16 inch with 14 ounce of force for mandibular protraction and maxillary retraction. Patients are instructed to wear them for a minimum of 16 h per day and to change them after every 2 days .
|
|
|
Inclusion Criteria
|
| Age From |
13.00 Year(s) |
| Age To |
15.00 Year(s) |
| Gender |
Both |
| Details |
1.The facial type of all patients was mesoprosopic to brachyprosopic with convex facial Profile suggestive of mild to moderate Angles Class II Divison I Malocclusion with favourable growth pattern.
2.All patients with early permanent dentition with prepubertal growth spurt /circumpubertal growth spurt.
3.Patients of either gender
4.Both the dental arches well aligned and did not demand the Prefunctional phase.
5.Skeletal Maturity Analysis has been done for all subjects through cervical vertebral maturity index of Hassel and Farman (CVMI) and MP3 analysis.
All subjects were either in stage 3 or stage 4 of CVMI
These two skeletal maturity indices were selected as they give the amount of potential percentage of growth completed or remained. Above two indicators showed that the subjects were in about 30-45% of potential growth is remained.
6.Clinical VTO (Visualized Treatment Objective) was positive in each patient.
7.None of the subject had undergone any orthodontic treatment before inclusion of them in the present study.
8.All subjects were free from symptoms of temporomandibular joint disorders.
9.All subjects were free of subjective neuromuscular, auditory and mandibular dysfunction syndrome.
10.All patients who understand the treatment plan and are ready to give written Informed Consent.
11.All patients ready to complete the scheduled Follow-up
12.Functional, Clinical and Cephalometric evaluation suggested the functional retrusion of the lower jaw.
|
|
| ExclusionCriteria |
| Details |
1.Patients with Congenital deformity of Oro-Facial structures or having Pharyngeal pathology.
2.Patients with Systemic and Psychological disorders
3.Patients of Class II malocclusion with Severe Proclination of Lower Incisors
4.Patients with complaints of nasal obstruction.
5.Patients with Chronic ulcers in oral cavity.
6.Patients with Chronic Periodontitis.
7.Previously orthodontically treated Patients.
8.Patients whose growth phase has ceased.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| TO CORRECT RETRUDED LOWER JAW |
zero, six and twelve months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="28" Sample Size from India="28"
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/ Phase 3 |
|
Date of First Enrollment (India)
|
10/11/2023 |
| 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
|
Functional Bite Turbos made of composite are prepared intraorally
. Although this method saves the extra laboratory procedures. A high load
bearing composite resin (Anabond Blu-Bite resin, - flexural modulus 10500MPa,
Compressive strength 420MPa, Diametral strength 78MPa) is used to build the
turbos. Anabond blu-bite is a light
Cure Radiopaque Composite. It is a highly crosslinked polymeric material
composed of a mixture of two or more macromolecules which are essentially
insoluble.
Since the average height of the turbos was around 4-5mm, Some
amount of composite is scooped and packed at the base of Teflon coated
composite carrying instrument. Composite carrying instrument having the uncured
composite then carried intraorally to the respective dental arch and then
pressed tightly against the occlusal and bucco-lingual surfaces of the teeth.
Every care is taken to see that the composite block is snugly fitted over the
respective dental arch. Once the fit is assured, it is then held in the same
place and then photo-cured from all sides for 20 seconds. The same procedure is
then repeated for each of the remaining three quadrants until composite turbos are
glued onto the occlusal surfaced of each of the first premolars.
The turbos for the maxillary arch are made with the apex
roughly lying straight above the distal
margin of the maxillay first premolars.
The inclines (45 degrees) of the turbos slope downwards towards the mesial side
where it meets the tooth at its mesial margins.
The Turbos for the mandibular arch are made with the apex
roughly lying straight above the mesial margins of the mandibular first premolars.
The inclines (45degrees) of the turbos slope downwards towards the distal side
where it meets the tooth at its distal margins.
After curing of the turbos, routine methods of polishing
and finishing of turbos done by micromotor composite finishing burs. Any sharp
points or edges are eliminated to see to it that smooth, shiny and hygienic
turbos, non-irritable to the oral mucosa remain in the mouth.
All the necessary instructions pertaining to oral hygiene
maintenance are given to the subject. The patient is instructed to avoid hard
and a sticky food that may dislodge or break the Turbos.
After initial check, the patient is recalled after three
weeks. All points pertaining to maintenance of the Turbos were re-explained and
correct lower jaw movements.
Thereafter each patient was recalled after every four
weeks. At each clinical visit, it was confirmed either from the parent or from
the patient as to whether there was any discomfort for mastication, speech with
the appliance. Debonding of any of the bite turbos was checked for and
immediately repaired. |