| CTRI Number |
CTRI/2021/09/036996 [Registered on: 30/09/2021] Trial Registered Prospectively |
| Last Modified On: |
30/09/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Prevalence of tongue abnormalities in a hospital based population |
|
Scientific Title of Study
|
Prevalence of structural and functional abnormalities of tongue: A hospital based observational study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Angela Piplani |
| Designation |
Intern |
| Affiliation |
Manipal College Of Dental Sciences,Manipal |
| Address |
Manipal karnataka
Shambhavi Sovereign 108-B
Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
8700612626 |
| Fax |
|
| Email |
piplani.angel@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vineetha R |
| Designation |
Professor and Head |
| Affiliation |
Manipal College Of Dental Sciences,Manipal |
| Address |
Department of Oral Medicine and Radiology, MCODS, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9964896254 |
| Fax |
|
| Email |
vineetha.manu@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mathangi K |
| Designation |
Assistant Professor |
| Affiliation |
Manipal College Of Dental Sciences,Manipal |
| Address |
Department of Oral Medicine and Radiology, MCODS, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9620299924 |
| Fax |
|
| Email |
mathangi.kumar@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Self-sponsored
Institute name- Manipal College of Dental Sciences, Manipal, Karnataka |
|
|
Primary Sponsor
|
| Name |
Self Sponsored PI Angela Piplani |
| Address |
Department of Oral Medicine and Radiology, MCODS, Manipal |
| Type of Sponsor |
Private medical college |
|
|
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 Mathangi K |
Manipal College of Dental Sciences, Manipal |
Department of Oral Medicine and Radiology, Room no. 1 Manipal, Karnataka
Udupi
KARNATAKA |
9620299924
mathangi.kumar@manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy volunteers |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Dental OPD patients of age above 18 years to 70 years who will be willing to participate
in study |
|
| ExclusionCriteria |
| Details |
Patients who are not willing to participate
Patients with severe restriction of mouth opening |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
1. To assess the prevalence of normal variants and pathologic lesions affecting the tongue
2. To assess the normal tongue protrusion in the study population and any functional abnormality
associated |
6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
2. To assess the normal tongue protrusion in the study population and any functional abnormality
associated |
6 months |
|
|
Target Sample Size
|
Total Sample Size="3000"
Sample Size from India="3000"
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)
|
01/10/2021 |
| 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 Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Not applicable |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The tongue is a prominent muscular organ of the oral cavity which plays a vital role in speech, mastication and digestion. Tongue changes can reflect the oral and overall health status of an individual. Oral cavity, being the portal of entry to various infectious and carcinogenic agents, mucosa of the tongue is easily exposed to pathologic changes as well. The changes in the colour, texture, size, shape, appearance and function of the tongue can indicate the various diseases affecting the body. Conditions affecting the tongue can range from developmental aetiology to neoplastic involvement.1,2 These changes can be either due to local factors like trauma, contact allergy, neoplasm etc., or it can be the oral manifestation of underlying systemic disorders. At times, tongue manifestation can be the easy and early diagnostic clue for identifying nutritional deficiencies, bacterial and viral diseases or even immune-mediated diseases. Not only the structural abnormalities, the functional abnormalities like taste and movement of the tongue are also reported in a few conditions like oral submucous fibrosis, malignancies affecting the base of the tongue or neuromuscular disorders. Unless symptomatic, these tongue abnormalities often go unnoticed. Detailed tongue examination is a crucial aspect of oral examination that dentists often overlook unless the patient reports any symptoms.2 Our study intends to assess the prevalence of structural and functional abnormalities of the tongue in patients visiting our hospital and its possible correlation with the patient’s medical status and symptoms reported. This study will also help understand the symptomatic and asymptomatic significant tongue abnormalities commonly seen in our patients. None of the Indian studies have so far checked both the structural and functional abnormalities of tongue in detail to best of our knowledge. |