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 Modification(s)	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
Secondary IDs if Any	Secondary ID  Registry  NIL  NIL
Details of Principal Investigator or overall Trial Coordinator (multi-center study)	Name  Angela Piplani  Address  Manipal karnataka Shambhavi Sovereign 108-B Manipal Udupi KARNATAKA 576104 India  Phone  8700612626   Fax     Email  piplani.angel@gmail.com
Details Contact Person Scientific Query Modification(s)	Name  Dr Vineetha R  Address  Department of Oral Medicine and Radiology, MCODS, Manipal Udupi KARNATAKA 576104 India  Phone  9964896254   Fax     Email  vineetha.manu@manipal.edu
Details Contact Person Public Query	Name  Dr Mathangi K  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 Modification(s)	Self-sponsored Institute name- Manipal College of Dental Sciences, Manipal, Karnataka
Primary Sponsor Modification(s)	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	Name  Address  NIL  NIL
Countries of Recruitment	India
Sites of Study Modification(s)	No of Sites = 1   Contact Person  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   9620299924 mathangi.kumar@manipal.edu
Details of Ethics Committee Modification(s)	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	Status  Not Applicable
Health Condition / Problems Studied	Health Type  Condition  Healthy Human Volunteers  Healthy volunteers
Intervention / Comparator Agent	Type  Name  Details
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 Modification(s)	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"
Phase of Trial Modification(s)	N/A
Date of First Enrollment (India) Modification(s)	01/10/2021
Date of First Enrollment (Global)	No Date Specified
Estimated Duration of Trial	Years="0" Months="6" Days="0"
Recruitment Status of Trial (Global) Modification(s)	Not Applicable
Recruitment Status of Trial (India)	Not Yet Recruiting
Publication Details	Not applicable
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.