| CTRI Number |
CTRI/2024/05/066942 [Registered on: 07/05/2024] Trial Registered Prospectively |
| Last Modified On: |
07/06/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
retrospective |
| Study Design |
Other |
|
Public Title of Study
|
Cbct utility for pharyngeal airway in cleft patient |
|
Scientific Title of Study
|
Assessment of the pharyngeal
airway in individuals with
non-syndromic cleft lip and palate using cone beam computed tomography |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shalu Rai |
| Designation |
Principal |
| Affiliation |
Manav Rachna Dental College School of Dental Sciences |
| Address |
Manav Rachna Dental College School of Dental Sciences
Manav Rachna Dental College School of Dental Sciences
Faridabad
HARYANA
121001
India |
| Phone |
09891353960 |
| Fax |
|
| Email |
drshalurai@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Shalu Rai |
| Designation |
Principal |
| Affiliation |
|
| Address |
C-1 Sector 23 NOIDA
C-1 Sector 23 NOIDA
Gautam Buddha Nagar
UTTAR PRADESH
201301
India |
| Phone |
9999448961 |
| Fax |
|
| Email |
drshalurai@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Shalu Rai |
| Designation |
Principal |
| Affiliation |
Manav Rachna Dental College School of Dental Sciences |
| Address |
Manav Rachna Dental College School of Dental Sciences
Manav Rachna Dental College School of Dental Sciences
Faridabad
HARYANA
121001
India |
| Phone |
09891353960 |
| Fax |
|
| Email |
sumit.mrdc@mrei.ac.in |
|
|
Source of Monetary or Material Support
|
| Manav Rachna Dental College, School of Dental Sciences, Faridabad, Haryana, India 121003 |
|
|
Primary Sponsor
|
| Name |
Shalu Rai |
| Address |
Manav Rachna Dental College, School of Dental Sciences, Faridabad, Haryana, India 121003 |
| 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 Shalu rai |
Manav Rachna Dental College School of Dental Sciences |
Department of Oral Medicine and Radiology
Faridabad
HARYANA |
9999448961
drshalurai@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Preventative or screening interventions |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
9.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients in the age group of 9-12 years presenting with ANGLE’S CLASS I OCCLUSION as Controls.
2. Patients with Surgically repaired cleft.
3. Patients with hare lip or a congenital fissure of hard palate with unilateral or bilateral defects with complete records of the patients.
4. Pretreatment patients (pre expansion).
5. Patients who agreed to have their CBCT scans utilized for investigation were subjected to the further assessment.
|
|
| ExclusionCriteria |
| Details |
• Patients who would not give consent for CBCT.
• Patients with systemic abnormalities (uncontrolled diabetes, pregnancy, hepatitis)
• Presence of airway pathology, history of adenoidectomy or tonsillectomy.
• Presence of periodontal pathology, absence of maxillary 1st permanent Molars.
• Patients with bone disorders.
• Confirmed Obstructive Sleep Apnea patients
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Height of nasopharyngeal airway
and width of nasopharyngeal airway |
At Baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Height & width of oropharyngeal airway
|
At baseline |
| Height & width of hypopharyngeal airways |
At baseline |
| Area of airway |
At baseline |
| Volume of airway |
BEFORE THE START OF Orthodontic treatment planning ( baseline) |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
18/05/2024 |
| Date of Study Completion (India) |
01/05/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
article publised |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
Morphometric measurements of the pharyngeal airway are of great importance for clinicians and radiologists during diagnosis and treatment of cleft lip and palate. The combined analysis of these factors can provide valuable insights for accurate orthodontic treatment planning and rehabilitation of these patients. The research may have important applications as a proper diagnosis must underpin the treatment at every level for it to be effective. Unquestionably, 3D imaging diagnosis is necessary for accurate evaluation and diagnosis of CLP patients. In order to reduce the quantity of CBCT exposures and radiation doses given to children, the scheduling of the test is crucial. |