| CTRI Number |
CTRI/2019/02/017501 [Registered on: 06/02/2019] Trial Registered Prospectively |
| Last Modified On: |
07/02/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
TO MEASURE THREE DIMENSIONSAL UPPER AIRWAY CHANGES AFTER RAPID MAXILLARY EXPANSION IN MOUTH BREATHING CHILDREN |
|
Scientific Title of Study
|
THREE-DIMENSIONAL EVALUATION OF UPPER AIRWAY VOLUME CHANGES AFTER RAPID MAXILLARY EXPANSION IN MOUTH BREATHING CHILDREN USING CONE BEAM COMPUTED TOMOGRAPHY |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)
|
| Name |
Priyanka sharma |
| Designation |
Post graduate student |
| Affiliation |
Govt. Dental College and Hospital, Nagpur |
| Address |
DEPT. OF PEDODONTICS AND PREVENTIVE DENTISTRY, ROOM NO. 108, GOVT. DENTAL COLLEGE AND HOSPITAL, GOVT.MEDICAL COLLEGE CAMPUS, MEDICAL SQUARE. NAGPUR
Nagpur
MAHARASHTRA
440003
India |
| Phone |
9960874550 |
| Fax |
|
| Email |
psfeb31991@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Priyanka sharma |
| Designation |
Post graduate student |
| Affiliation |
Govt. Dental College and Hospital, Nagpur |
| Address |
DEPT OF PEDODONTICS AND PREVENTIVE DENTISTRY, ROOM NO. 108,GOVT DENTAL COLLEGE AND HOSPITAL, GOVT MEDICAL COLLEGE CAMPUS.
Nagpur
MAHARASHTRA
440003
India |
| Phone |
9960874550 |
| Fax |
|
| Email |
psfeb31991@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr RITESH KALASKAR |
| Designation |
PROFESSOR AND HOD |
| Affiliation |
Govt. Dental College and Hospital, Nagpur |
| Address |
DEPT OF PEDODONTICS AND PREVENTIVE DENTISTRY, ROOM NO. 108,GOVT DENTAL COLLEGE AND HOSPITAL, GOVT MEDICAL COLLEGE CAMPUS.
Nagpur
MAHARASHTRA
440003
India |
| Phone |
8550938585 |
| Fax |
|
| Email |
riteshpedo@gmail.com |
|
|
Source of Monetary or Material Support
|
| GOVT DENTAL COLLEGE & HOSPITAL, GMC CAMPUS. MEDICAL SQUARE. NAGPUR |
|
|
Primary Sponsor
|
| Name |
PRIYANKA SHARMA |
| Address |
DEPT OF PEDODONTICS AND PREVENTIVE DENTISTRY, ROOM NO. 108,GOVT DENTAL COLLEGE AND HOSPITAL, GOVT MEDICAL COLLEGE CAMPUS. |
| 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 |
| PRIYANKA SHARMA |
GOVT DENTAL COLLEGE & HOSPITAL |
GOVT MEDICAL COLLEGE CAMPUS, MEDICAL SQUARE. NAGPUR- 440003
Nagpur
MAHARASHTRA |
9960874550
psfeb31991@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| GOVT DENTAL COLLEGE,NAGPUR |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J00-J99||Diseases of the respiratory system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
| Intervention |
RAPID MAXILLARY EXPANSION |
HYRAX EXPANSION SCREW USED AS RAPID MAXILLARY EXPANSION DEVICE IN MOUTH BREATHING CHILDREN HAVING NARROW MAXILLARY ARCH |
|
|
Inclusion Criteria
|
| Age From |
9.00 Year(s) |
| Age To |
14.00 Year(s) |
| Gender |
Both |
| Details |
CONSTRICTED MAXILLARY ARCH, UNILATERAL OR BILATERAL CROSSBITE, MOUTH BREATHING PATIENTS |
|
| ExclusionCriteria |
| Details |
ENLARGED ADENOIDS, ALLERGIC RHINITIS OR SINUSITIS, ANTERIOR OPEN BITE, STEEP MANDIBULAR PLANE ANGLE, DEVIATED NASAL SEPTUM |
|
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Method of Generating Random Sequence
|
|
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Method of Concealment
|
|
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Blinding/Masking
|
|
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Primary Outcome
|
| Outcome |
TimePoints |
| SIGNIFICANT INCREASE IN THE UPPER AIRWAY VOLUME THAT IS NASAL, NASOPHARYNGEAL,OROPHARYNGEAL AIRWAY VOLUME WHICH CORRECTS THE MOUTH BREATHING HABIT IN CHILDREN |
APPLIANCE ACTIVATION FOR 2-3 WEEKS
RETENTION PERIOD OF 3 MONTHS AFTER WHICH THE AIRWAY VOLUME WOULD BE RECORDED |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| CORRECTION OF THE MOUTH BREATHING HABIT IN CHILDREN |
APPLIANCE ACTIVATION FOR 2-3 WEEKS
RETENTION PERIOD OF 3 MONTHS AFTER WHICH THE EVALUATION OF THE MOUTH BREATHING HABIT WOULD BE DONE |
|
|
Target Sample Size
|
Total Sample Size="16"
Sample Size from India="16"
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)
|
11/02/2019 |
| 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="8"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NONE YET |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
THE INDIVIDUALS WITH MOUTH BREATHING POSSESS A NARROW AND V-SHAPED MAXILLARY ARCH, A HIGH PALATAL VAULT AND LONG FACE. RME ( RAPID MAXILLARY EXPANSION ) PROMOTES ORTHOPEDIC EXPANSION OF MAXILLA THROUGH SEPARATION OF THE MEDIAN PALATINE SUTURE, THUS CORRECTING POSTERIOR CROSSBITE. BECAUSE PALATE CORRESPONDS TO THE NASAL BASE, NASAL CONSEQUENCES DUE TO THIS PROCEDURE HAVE BEEN CITED. THE NASAL MODIFICATIONS DUE TO RME MAY THEREBY IMPROVE THE RESPIRATORY PATTERN. AS A RESULT, SOME INVESTIGATORS HAVE STATED THAT THE PROCEDURE REDUCES NASAL AIR RESISTANCE AND INCREASES NASAL VOLUME. THE EFFECTS OF RME OVER NASAL SIZE AND VOLUME HAVE BEEN RESEARCHED WITH VARIOUS PROCEDURES SUCH AS LATERAL CEPHALOGRAMS, ANTEROPOSTERIOR RADIOGRAPHS, MULTISLICE CT. LAT CEPH AND AP VIEW GIVES TWO DIMENSIONAL PICTURE WHEREAS THERE IS HIGH RADIATION HAZARD WITH CT. LOW COST, LOWER RADIATION DOSE, SHORTER SCANNING TIME AND OVERALL ACCURACY HAS MADE CBCT TECHNOLOGY A PREFERRED METHOD TO ASSESS AIRWAY. CBCT HAS MADE IT POSSIBLE TO VISUALIZE AIRWAY AS A SOLID STRUCTURE. HENCE IN THIS STUDY WE WILL EVALUATE UPPER AIRWAY CHANGES AND AT THE SAME TIME ASSESS ITS EFFECT ON MOUTH BREATHING HABIT. MOUTH BREATHING HABIT WOULD BE EVALUATED USING MIRROR TEST AND BUTTERFLY TEST. |