| CTRI Number |
CTRI/2024/11/076248 [Registered on: 04/11/2024] Trial Registered Prospectively |
| Last Modified On: |
29/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparing the clinical effectiveness of mouth taping and oral screen in mouth breathing patient. |
|
Scientific Title of Study
|
Comparative evaluation of mouth taping and oral screen in children with mouth breathing habit - A randomised control trial. |
| 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 HIBA RASHEED |
| Designation |
Junior Resident II |
| Affiliation |
PMS college of Dental Science and Research |
| Address |
Department of Pediatric and Preventive Dentistry
PMS college of DentaL Science and Research Golden Hills, Vattapara,Venkode, Thiruvanathapuram ,kerala
Thiruvananthapuram
KERALA
695028
India |
| Phone |
8138894512 |
| Fax |
|
| Email |
hiba.jubi@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Anandaraj S |
| Designation |
Professor |
| Affiliation |
PMS college of Dental Science and Research |
| Address |
Department of Pediatric and Preventive Dentistry
PMS college of DentaL Science and Research Golden Hills, Vattapara,Venkode, Thiruvanathapuram ,kerala
Thiruvananthapuram
KERALA
695028
India |
| Phone |
9447343206 |
| Fax |
|
| Email |
dranandraj@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
HIBA RASHEED |
| Designation |
Junior Resident II |
| Affiliation |
PMS college of Dental Science and Research |
| Address |
Department Of Pediatric & Preventive Dentistry
PMS College of Dental Science & Research Golden Hills,Vattapara,Venkode,Thiruvanathapuram
Thiruvananthapuram
KERALA
695028
India |
| Phone |
8138894512 |
| Fax |
|
| Email |
hiba.jubi@gmail.com |
|
|
Source of Monetary or Material Support
|
| dept of pediatric and preventive dentistry PMS college of DentaL Science and Research Golden Hills, Vattapara,Venkode, Thiruvanathapuram ,kerala India 695028 |
|
|
Primary Sponsor
|
| Name |
HIBA RASHEED |
| Address |
Darul Hiba,KN 52 kallattunagar Manacaud P O,Thiruvanathapuram, Kerala India 695009 |
| 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 |
| Dr Hiba Rasheed |
PMS college of Dental Science and Research |
Department of Pediatric and Preventive Dentistry
Thiruvananthapuram
KERALA |
8138894512
hiba.jubi@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| institutional ethics committe,PMS College of Dental Science and Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K089||Disorder of teeth and supporting structures, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
myotape |
mechanotheraphy used or mouth breathing habit for 6 months during night time |
| Intervention |
oral screen |
oral screen for mechnotheraphy for mouth breathing habit for 6 months during night time |
|
|
Inclusion Criteria
|
| Age From |
8.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
• Children between 8-12years with mouth breathing habit .
• Patients who are mouth breathers with no nasal obstruction and have short upper lip/ increased overjet/ long face/ constricted upper arch/ incompetent lips.
• Patients who are mouth breathers with no nasal obstruction but have snoring/allergic rhinitis/asthma.
|
|
| ExclusionCriteria |
| Details |
• History of nasal surgery.
• The patient with a deviated nasal septum, nasal polyp and adenoid hypertrophy.
• Medically compromised and differently-abled children.
• History of allergy to myotape and methyl methacrylate.
• The patient is not willing to take part in the study.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Double Blind Double Dummy |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Clinical parameter and cast assessments such as Lip length, lip competence, nasolabial angle, molar relation, overjet, overbite, arch length, intercanine and intermolar width, palatal depth, and secondary parameters such as presence/absence of snoring, frequency of allergic rhinitis and asthma, patient and parent satisfaction of both study groups will be evaluated |
at 3rd month and 6th month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="36"
Sample Size from India="36"
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)
|
20/11/2024 |
| 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 Yet Recruiting |
| 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
|
Clinical parameter and cast assessments such as Lip length, lip competence, nasolabial angle,
molar relation, overjet, overbite, arch length, intercanine and intermolar
width, palatal depth, and secondary parameters such as presence/absence of
snoring, frequency of allergic rhinitis and asthma, patient and parent
satisfaction of both study groups will be evaluated and based on these factors treatment can be tailored and thus giving effective solution for mouth breathing habit |