| CTRI Number |
CTRI/2025/06/089177 [Registered on: 19/06/2025] Trial Registered Prospectively |
| Last Modified On: |
13/06/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
A STUDY IN CHILDREN WITH SLEEP PROBLEMS TO COMPARE THE EFFECT OF JAW EXPANSION WITH OR WITHOUT FACIAL MUSCLE EXERCISES ON IMPROVING SLEEP QUALITY |
|
Scientific Title of Study
|
Comparative evaluation of slow maxillary expansion with or without orofacial myofunctional therapy in children with disturbed sleep disorders - A randomized 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 |
NEGHA BIJU |
| Designation |
JUNIOR RESIDENT |
| Affiliation |
ANNOOR DENTAL COLLEGE AND HOSPITAL |
| Address |
POST GRADUATE STUDENT
DEPARTMENT OF PEDIATRIC AND PREVENTIVE DENTISTRY
ANNOOR DENTAL COLLEGE
PERUMATTOM
MUVATTUPUZHA
Ernakulam
KERALA
686691
India |
| Phone |
9645832247 |
| Fax |
|
| Email |
drneghabiju@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
JOBY PETER |
| Designation |
PROFESSOR AND HEAD |
| Affiliation |
ANNOOR DENTAL COLLEGE AND HOSPITAL |
| Address |
DEPT PEDIATRIC AND PREVENTIVE DENTISTRY
ANNOOR DENTAL COLLEGE
PERUMATTOM
Ernakulam
KERALA
686673
India |
| Phone |
9446321220 |
| Fax |
|
| Email |
jobspeter77@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
KRISHNAKUMARR |
| Designation |
PROFESSOR |
| Affiliation |
ANNOOR DENTAL COLLEGE AND HOSPITAL |
| Address |
DEPT PEDIATRIC AND PREVENTIVE DENTISTRY
ANNOOR DENTAL COLLEGE AND HOSPITAL
PERMATTOM
Ernakulam
KERALA
686673
India |
| Phone |
9539796205 |
| Fax |
|
| Email |
info@annoordentalcollege.org |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
self funded |
| Address |
ANNOOR DENTAL COLLEGE AND HOSPITAL |
| Type of Sponsor |
Other [Academic investigator initiated] |
|
|
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 |
| NEGHA BIJU |
ANNOOR DENTAL COLLEGE AND HOSPITAL |
DEPARTMENT OF PEDIAATRIC AND PREVENTIVE DENTISTRY
ANNOOR DENTAL COLLEGE AND HOSPITAL
Ernakulam
KERALA |
9645832247
drneghabiju@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ANNORDENTALCOLLEGEIHEC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K088||Other specified disorders of teethand supporting structures, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
All groups receiving active treatment |
All groups are reciving active treatment
group 1 Hawleys with jack screw
group 2 hawleys with jack screw and Orofacial myofunctional therapy
group 3 modified palatal expansion appliance
group 4 modified palatal expansion appliance and orofacial myofunctional therapy |
| Intervention |
Orofacial Myofunctional Therapy (OMT) combined with Slow Maxillary Expansion (SME) |
Participants will receive SME using either a removable appliance (Hawley with jack screw) or a fixed appliance (modified palatal expander), along with a structured OMT protocol.
OMT includes isotonic and isometric exercises for oral and pharyngeal muscles, performed 20 times each in the morning and evening, 5 days per week, for 6 months. Instructions are reinforced monthly and compliance is tracked using a log card |
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
Children aged 6 to 12 years
Diagnosed with disturbed sleep using BEARS and SDSC tools
ENT clearance for dental intervention
|
|
| ExclusionCriteria |
| Details |
Children above 12 years
Undergoing orthodontic treatment
Patient requires skeletal expansion
Severe crowding
Skeletal cross bite |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improvement in sleep of the child will be measured by questionnaire |
baseline and after 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Trans palatal width will be measured in millimetre from the model.
Pharyngeal space assessment in millimetre lateral cephalogram.
Change in proclination will be measured in degree from the lateral cephalogram |
Baseline & after 6 months |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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)
|
01/07/2025 |
| 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="6"
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
|
TITLE - Comparative evaluation of slow maxillary expansion with or without orofacial myofunctional therapy in children with disturbed sleep disorders - A randomized control trial TYPE OF STUDY - Interventional randomized control trial PRIMARY OBJECTIVE - To compare the effectiveness of slow maxillary expansion with or without orofacial myofunctional therapy in improving sleep quality in children with disturbed sleep disorders SECONDARY OBJECTIVE - To assess the change in transpalatal arch width post treatment , to revaluate improvement in airway space using lateral cephalogram , to asses changes in anterior tooth proclination STUDY DESIGN - 4 arm parellel group, randomised control trial ALLOCATION simple random sampling using lottery method Blinding open label group 1 Removable slow maxillary expansion Hawleys with jack screw group 2 removable slow maxillary expansion with orofacial myofunctional therapy group 3 fixed slow maxillary expansion modified palatal expansion appliance group 4 fixed slow maxillary expansion with orofacial myofunctional therapy Data collection - department of pediatric and preventive dentistry annoor dental college |