| CTRI Number |
CTRI/2020/09/027888 [Registered on: 18/09/2020] Trial Registered Prospectively |
| Last Modified On: |
27/07/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Case Control Study |
| Study Design |
Other |
|
Public Title of Study
|
Comparison of oral microbiome in orthodontic patients at Sleep Apnea risk with non-risk patients. |
|
Scientific Title of Study
|
Flowcytometric analysis of oral microbiome in orthodontic patients with Obstructive Sleep Apnea risk: A comparative pilot study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Priyanka kapoor |
| Designation |
Professor |
| Affiliation |
Jamia Millia Islamia |
| Address |
Dept of Orthodontics
Faculty of Dentistry, Jamia Millia Islamia
South
DELHI
110025
India |
| Phone |
9891914997 |
| Fax |
|
| Email |
pkapoor@jmi.ac.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Zahid Ashraf |
| Designation |
Professor |
| Affiliation |
Jamia Millia Islamia |
| Address |
Dept of Biotechnology, Jamia Millia Islamia
South
DELHI
110025
India |
| Phone |
9871426706 |
| Fax |
|
| Email |
zashraf@jmi.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Aman Chowdhry |
| Designation |
Professor |
| Affiliation |
Jamia Millia Islamia |
| Address |
Dept of Oral Pathology
Faculty of Dentistry, Jamia Millia Islamia
South
DELHI
110025
India |
| Phone |
9810464443 |
| Fax |
|
| Email |
achowdhry@jmi.ac.in |
|
|
Source of Monetary or Material Support
|
| Jamia Millia Islamia University, New Delhi |
|
|
Primary Sponsor
|
| Name |
Priyanka Kapoor |
| Address |
Dept of Orthodontics, Faculty of Dentistry, Jamia millia Islmia, New Delhi |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Jamia Millia Islamia |
Jamia Millia Islamia, New Delhi, 110025 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Priyanka Kapoor |
Faculty of Dentistry, Jamia Millia Islamia |
Room No.210, Dept. of Orthodontics
South
DELHI |
9891914997
pkapoor@jmi.ac.in |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Internal Ethical Review Committee, Jamia Millia Islamia |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K117||Disturbances of salivary secretion, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
10.00 Year(s) |
| Age To |
19.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients in 10-19 years of age.
2. Patients requiring fixed orthodontic treatment.
|
|
| ExclusionCriteria |
| Details |
1. Patients requiring removable orthodontic treatment.
2. Patients with growth abnormalities/ syndromes/ mentally challenged.
3. Patients with reported periodontal problems/ metabolic disturbances.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| Microbial abundance from 6 different sites in mouth at three different time points using flowcytometry in orthodontic OSA-risk and Non-risk patients |
At baseline(Before orthodontic treatment start, 4 weeks, 24 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Prevalence of OSA-risk in Orthodontic patients using questionnaire based screening |
At the time of allocation into OSA- Risk and Non-risk groups |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
Final Enrollment numbers achieved (Total)= "24"
Final Enrollment numbers achieved (India)="24" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
11/01/2021 |
| Date of Study Completion (India) |
11/03/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
11/03/2025 |
|
Estimated Duration of Trial
|
Years="3"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NA |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Establishing the dynamics of oral microbiota in OSA-risk orthodontic patients can help identify the potential population at OSA-risk before further confirmatory diagnosis and also to outline the specific needs in OSA patients regarding oral health care. The current study will attempt to address this gap in current OSA research using flowcytometry and also compare it sequentially with non-orthodontic oral microbial abundance. The advantage of flowcytometry calculating absolute abundance data for microbial count, a possibility of, compared to relative abundances can allow comparisons between OSA-risk and Non–risk and also critical values can be determined for OSA– risk, if possible. AIM: To compare difference in oral microbial abundance in OSA risk and non-risk orthodontic patients with flowcytometry within specified oral micro-habitats. OBJECTIVES: 1. To assess and compare microbial abundance using flowcytometry in OSA risk and non-risk orthodontic patients within 6 oral microhabitats at three different observation times. 2. To compare microbial abundance using flowcytometry in orthodontic vs non orthodontic patients within 6 oral microhabitats. |