FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
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  
NIL 
 
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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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.

 
Close