| CTRI Number |
CTRI/2024/04/066366 [Registered on: 26/04/2024] Trial Registered Prospectively |
| Last Modified On: |
04/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparing airway changes in patients with cleft lip and palate in early age when treated with aligners and expanders. |
|
Scientific Title of Study
|
Comparative Assessment of Volumetric Airway Changes in Unilateral Cleft Lip and Palate patients in Mixed Dentition treated for Maxillary Expansion using Aligners and Ni-Ti palatal expander: A 3-D CBCT 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 Riddhi Bansal |
| Designation |
Post gradute student |
| Affiliation |
Manav Rachna Dental College |
| Address |
Manav Rachna Dental College
School of Dental Sciences
MRIIRS
Department no 3
Ground floor
Surajkund Road
Faridabad
HARYANA
121003
India
Faridabad HARYANA 121003 India |
| Phone |
8827269156 |
| Fax |
|
| Email |
bansalriddhi4@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Puneet Batra |
| Designation |
Principal (Prof) HOD |
| Affiliation |
Manav Rachna Dental College |
| Address |
Manav Rachna Dental College
School of Dental Sciences
MRIIRS
Department no 3
Ground floor
Surajkund Road
Faridabad
HARYANA
121003
India
Faridabad HARYANA 121003 India |
| Phone |
9810335961 |
| Fax |
|
| Email |
drpuneetbatra@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Riddhi Bansal |
| Designation |
Post gradute |
| Affiliation |
Manav Rachna Dental College |
| Address |
Manav Rachna Dental College
School of Dental Sciences
MRIIRS
Department no 3
Ground floor
Surajkund Road
Faridabad
HARYANA
121003
India
Faridabad HARYANA 121003 India |
| Phone |
8827269156 |
| Fax |
|
| Email |
bansalriddhi4@gmail.com |
|
Source of Monetary or Material Support
Modification(s)
|
| Manav Rachna Dental College School of Dental Sciences MRIIRS Department no 3 Ground
Floor Surajkund Road Faridabad Haryana India Pin- 121003 |
|
|
Primary Sponsor
|
| Name |
Dr. Riddhi Bansal |
| Address |
Manav Rachna Dental College
School of Dental Sciences
MRIIRS
Department no 3
Ground floor
Surajkund Road
Faridabad |
| Type of Sponsor |
Other [Self-funded] |
|
|
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 Riddhi Bansal |
MANAV RACHNA DENTAL COLLEGE |
Department of Orthodontics and Dentofacial Orthopedics
Department no 3
Ground floor
Surajkund Road
Faridabad Faridabad HARYANA |
8827269156
bansalriddhi4@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Manav Rachna Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K008||Other disorders of tooth development, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Aligners |
Maxillary expansion will be done with Aligners till the arch is expanded and crossbite is corrected and assessment of volumetric airway changes will be done immediately after the expansion is achieved at T1 (after expansion) |
| Intervention |
NiTi palatal expander |
Maxillary expansion will be done with NiTi palatal expander till complete dentoalveolar expansion is achieved and crossbite is corrected and assessment of volumetric airway changes will be done after the desired expansion is achieved at the time of removal of expansion appliance at T1 (after expansion) |
|
|
Inclusion Criteria
|
| Age From |
7.00 Year(s) |
| Age To |
11.00 Year(s) |
| Gender |
Both |
| Details |
Complete unilateral cleft lip and palate
Both sexes
Age group from 7 years to 11 years
|
|
| ExclusionCriteria |
| Details |
Syndromic cleft lip and palate patients
Individuals with systemic diseases affecting bone density
Erupted permanent canines
Bilateral cleft lip and palate patients
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the volumetric airway changes after maxillary expansion using aligners and Ni-Ti palatal expander in unilateral cleft lip and palate patients in mixed dentition palate patients in mixed dentition |
T0- Before expansion
T1- After expansion |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To evaluate changes in questionnaire based assessment of OSA risk in UCLP patients treated with expansion appliances |
T0- Before expansion
T1- After expansion |
|
|
Target Sample Size
|
Total Sample Size="24" Sample Size from India="24"
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 4 |
|
Date of First Enrollment (India)
|
28/05/2024 |
| 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="2" 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
|
One of the most prevalent congenital abnormalities of the craniofacial region, cleft lip and palate(CLP) accounts for about 15% of all congenital deformities globally. The accompanying facial traits of children with CLP include a retrognathic maxilla and midface hypoplasia, which leads to diminished upper airway dimensions that do not improve even with surgical treatment. In children, the primary cause of respiratory problems is the obstruction of upper airway which is relieved by Rapid Maxillary Expansion (RME) which is also frequently employed to address the transverse deficiency. However, comparative studies show that Slow Maxillary Expansion(SME) provide more controlled anterior expansion than RME and is also equally effective in increasing pharyngeal airway volume in growing patients. Both Ni-Ti palatal expander and Aligners effectively causes SME, but aligners provide an added advantage to improve the alignment of dentition simultaneously with expansion. In this study, we will be doing a comparative assessment of volumetric airway changes in cleft lip and palate patients when treated with aligners and Ni-Ti palatal expander. |