| CTRI Number |
CTRI/2025/02/079842 [Registered on: 03/02/2025] Trial Registered Prospectively |
| Last Modified On: |
01/02/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
comparison of usage of adjustable and non adjustable masks on dental professionals |
|
Scientific Title of Study
|
Exploring The Relationship Between Headache/Temporomandibular Joint Disorders And Mouth
Masks among Dental Professionals: A Cross Over Randomized Controlled 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 |
Maaz Vohra |
| Designation |
PG student |
| Affiliation |
Saveetha Dental College and Hospitals |
| Address |
Clinic 24, 4th floor, Department of Prosthodontics, Saveetha Dental College and Hospitals, Poonamallee High Road, Velapanchavadi, Chennai
Chennai
TAMIL NADU
600076
India |
| Phone |
|
| Fax |
|
| Email |
maazvohra390@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Amrutha Shenoy |
| Designation |
Assistant Professor |
| Affiliation |
Saveetha Dental College and Hospitals |
| Address |
Clinic 24, 4th floor, Department of Prosthodontics, Saveetha Dental College and Hospitals, Poonamallee High Road, Velapanchavadi, Chennai
Chennai
TAMIL NADU
600077
India |
| Phone |
9819122808 |
| Fax |
|
| Email |
amruthashenoyd.sdc@saveetha.com |
|
Details of Contact Person
Public Query
|
| Name |
Amrutha Shenoy |
| Designation |
Assistant Professor |
| Affiliation |
Saveetha Dental College and Hospitals |
| Address |
Clinic 24, 4th floor, Department of Prosthodontics, Saveetha Dental College and Hospitals, Poonamallee High Road, Velapanchavadi, Chennai
Chennai
TAMIL NADU
600077
India |
| Phone |
9819122808 |
| Fax |
|
| Email |
amruthashenoyd.sdc@saveetha.com |
|
|
Source of Monetary or Material Support
|
| Saveetha Dental College and Hospitals, Poonamallee high road, Velapanchavadi, Chennai 600077, Tamil Nadu, India |
|
|
Primary Sponsor
|
| Name |
Saveetha Dental College and Hospitals |
| Address |
Poonamallee high road, Velapanchavadi, Chennai 600077, Tamil Nadu, India |
| Type of Sponsor |
Private hospital/clinic |
|
|
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 Amrutha Shenoy |
Saveetha Dental College and Hospitals |
Clinic 24, 4th floor, Department of Prosthodontics, Saveetha Dental College and Hospitals, Poonamallee High Road, Velapanchavadi, Chennai, Tamil Nadu, India
Chennai
TAMIL NADU |
9819122808
amruthasehnoyd.sdc@saveetha.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Saveetha Dental College - Institutional Human Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Dental Professionals wearing masks for more than 6 hours daily |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
3 ply mask |
Professionals who wore masks for at least 6 hours per day, at baseline (0 months) and at 1 month |
| Intervention |
N95 mask |
Professionals who wore this type of masks for at least 6 hours per day, at baseline (0 months), and at 1 month |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Dental professionals, including dentists, dental hygienists, dental
assistants, and dental technicians, who possessed a minimum of three years of experience to ensure
regular and prolonged exposure to mask usage in their daily practice. |
|
| ExclusionCriteria |
| Details |
Participants with pre-existing headaches or
Temporomandibular joint disorders, a history of TMJ surgery or interventions, systemic diseases like
rheumatoid arthritis or lupus, pregnant or lactating women, individuals with head or neck trauma in the
past 6 months, those with a history of facial or neck surgery, and participants on opioids or other pain
management medications. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Pain intensity was evaluated using a 0–10 numerical rating scale (visual
analog scale (VAS) |
baseline (0 month), 1 month, 3 month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Temporomadibular joint disorders to be assessed using Joint vibration analysis |
baseline (0 month), 1 month, 3 month |
|
|
Target Sample Size
|
Total Sample Size="112"
Sample Size from India="112"
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 3 |
|
Date of First Enrollment (India)
|
21/02/2025 |
| 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="1"
Months="1"
Days="1" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
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
|
Prolonged mask use poses concerns like headaches and temporomandibular disorders (TMDs), yet research on their impact and comprehensive studies, especially for dental practitioners, remain scarce. This study will aim to assess the effectiveness of 3-ply masks versus N95 masks in preventing these issues |