| CTRI Number |
CTRI/2018/04/013111 [Registered on: 09/04/2018] Trial Registered Retrospectively |
| Last Modified On: |
29/03/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
A comparison of chewing efficiency and teeth contacts before and after treatment in patients with posteriorly positioned lower jaw in patients with extraction treatment plan and non extraction treatment plan. |
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Scientific Title of Study
|
A COMPARATIVE EVALUATION OF MASTICATORY EFFICIENCY AND OCCLUSAL CONTACTS IN CLASS II PATIENTS TREATED WITH UPPER PREMOLAR EXTRACTIONS AND FIXED FUNCTIONAL APPLIANCES.†|
| Trial Acronym |
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Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Kriti Sharma Rai |
| Designation |
Senior Lecturer |
| Affiliation |
IDST Dental College, Kadrabad, Modinagar, Uttar Pardesh, Ghaziabad, Uttar Pradesh 201204 |
| Address |
IDST Dental College, Kadrabad, Modinagar, Uttar Pardesh, Ghaziabad, Uttar Pradesh,India.
Meerut
UTTAR PRADESH
201204
India |
| Phone |
9627615848 |
| Fax |
|
| Email |
dr.kriti86in@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Puneet Batra |
| Designation |
Vice Principal, Professor and Head , Department of Orthodontics |
| Affiliation |
IDST Dental College, Kadrabad, Modinagar, Uttar Pardesh, Ghaziabad, Uttar Pradesh 201204 |
| Address |
IDST Dental College, Kadrabad, Modinagar, Uttar Pardesh, Ghaziabad, Uttar Pradesh,India.
Meerut
UTTAR PRADESH
201204
India |
| Phone |
9810335961 |
| Fax |
|
| Email |
drpuneetbatra@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Kriti Sharma Rai |
| Designation |
Senior Lecturer |
| Affiliation |
IDST Dental College, Kadrabad, Modinagar, Uttar Pardesh, Ghaziabad, Uttar Pradesh 201204 |
| Address |
IDST Dental College, Kadrabad, Modinagar, Uttar Pardesh, Ghaziabad, Uttar Pradesh,India.
Meerut
UTTAR PRADESH
201204
India |
| Phone |
9627615848 |
| Fax |
|
| Email |
dr.kriti86in@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr. Kriti Sharma Rai
Department of Orthodontics
IDST Dental College, Kadrabad, Modinagar, Uttar Pardesh, Ghaziabad, Uttar Pradesh 201204 |
|
|
Primary Sponsor
|
| Name |
Dr Kriti Sharma Rai |
| Address |
Department of Orthodontics and Dentofacial Orthopedics.
Institute of Dental Studies and Technologies
Kadrabad, Modinagar, Uttar Pardesh, Ghaziabad, Uttar Pradesh 201204 |
| Type of Sponsor |
Private hospital/clinic |
|
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Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Kriti Sharma Rai |
/Institute of Dental Studies and Technologies |
IDST Dental College, Kadrabad, Modinagar, Uttar Pardesh, Ghaziabad, Uttar Pradesh 201204
Ghaziabad
UTTAR PRADESH |
9627615848
dr.kriti86in@gmail.com |
|
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Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IDSTEC |
Approved |
|
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Regulatory Clearance Status from DCGI
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Skeletal Class II malocclusion with ANB more than 5° with convex profile., |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Mandibular Protraction Fixed Functional Appliance |
Correction of Class II Div I malocclusion. |
| Comparator Agent |
Upper first Premolar Extraction. |
For correction of Class II Div I malocclusion. |
|
|
Inclusion Criteria
|
| Age From |
14.00 Year(s) |
| Age To |
17.00 Year(s) |
| Gender |
Both |
| Details |
•All patients having Skeletal Class II malocclusion with ANB more than 5° with convex profile.
•Increased Overjet.
•Normal or marginally low angle cases i.e. SN-GoGn ≤ 32°.
•No history of previous orthodontic treatment.
•Class II patients that need to be treated either by camouflage i.e uniarch extraction or fixed functional appliance.
•No history of any systemic illness.
•Pre- treatment dentition with at least half the cusp width of Class II molar relation.
|
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| ExclusionCriteria |
| Details |
•Cases requiring all 4 first premolar extractions.
•Patients having any apparent clinical muscular problem/dysostosis.
•Patients having tempomandibular joint dysfunction.
•Patient having Mandibular Incisor plane angle ≥100°.
•Patient having severely attrited dentition/fractured/mobile teeth / Amelogenesis imperfecta/ erosion/bruxism.
•Patient having skeletal facial asymmetry and requiring definite surgical treatment.
|
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Method of Generating Random Sequence
|
Other |
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Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Not Applicable |
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Primary Outcome
|
| Outcome |
TimePoints |
Masticatory Efficiency and
Occlusal Contacts in upper first premolar extraction and fixed functional appliance cases. |
6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Occlusal Contacts in upper first premolar extraction and fixed functional appliance cases. |
6 months |
|
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Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
Final Enrollment numbers achieved (Total)= "20"
Final Enrollment numbers achieved (India)="20" |
|
Phase of Trial
|
Phase 3/ Phase 4 |
|
Date of First Enrollment (India)
|
22/11/2012 |
| Date of Study Completion (India) |
14/05/2014 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="11" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
None yet. |
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
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Brief Summary
|
Aim: The aim of this study was to evaluate and compare changes in masticatory efficiency and the functional occlusal contact relationship in patients treated with upper first premolar extraction cases and case with Fixed Functional Appliances (non-extraction cases). Materials and Methods: Two groups with ten patients each were selected. Group I was treated with upper first premolar extraction while Group II cases were treated with Fixed Functional Appliance (MPA IV). Masticatory efficiency was checked using spectrophotometry while occlusal contacts were checked using Tek Scan. Records were taken at T1: After completion of levelling and alignment and T2:- After space closure in upper first premolar extraction cases and after 6 months of Fixed functional appliance placement. Results: There was a significant difference during inter group comparison however during intra group comparison no statistically significant difference was found for masticatory efficiency. When compared between the two groups, there was reduced occlusal contact in Group I and increased duration for performing different movements. Conclusions: Skeletal Class II patients when treated with Fixed Functional appliance (non-extraction), there was an increase in masticatory efficiency, as they are corrected to Class I malocclusion. When compared between the two groups, there were reduced occlusal contact in Group I and reduced duration for performing different movements. Key words: Masticatory efficiency, occlusal contacts, Fixed Functional appliance |