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CTRI Number  CTRI/2022/02/040688 [Registered on: 28/02/2022] Trial Registered Prospectively
Last Modified On: 26/02/2022
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   This observational cross sectional study evaluates the prevalence, distribution and severity of tongue coatings according to the proposed classification of Tongue Coatings Severity Index. 
Scientific Title of Study   Prevalence, distribution and severity of tongue coatings according to the proposed classification of Tongue Coatings Severity Index. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Rajashri Kolte  
Designation  Professor and Guide 
Affiliation  VSPM Dental College and Research Centre 
Address  VSPM Dental College and Research Centre Digdoh Hills Hingna Road Nagpur 440019 Maharashtra India

Nagpur
MAHARASHTRA
440019
India 
Phone  9011071468  
Fax    
Email  drrajashrikolte@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Rajashri Kolte  
Designation  Professor and Guide 
Affiliation  VSPM Dental College and Research Centre 
Address  VSPM Dental College and Research Centre Digdoh Hills Hingna Road Nagpur 440019 Maharashtra India

Nagpur
MAHARASHTRA
440019
India 
Phone  9011071468  
Fax    
Email  drrajashrikolte@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Abhay P Kolte  
Designation  Professor and Guide HOD 
Affiliation  VSPM Dental College and Research Centre 
Address  VSPM Dental College and Research Centre Digdoh Hills Hingna Road Nagpur 440019 Maharashtra India

Nagpur
MAHARASHTRA
440019
India 
Phone  9011071467  
Fax    
Email  drabhaypkolte@gmail.com  
 
Source of Monetary or Material Support  
Dr Rajashri Kolte 
 
Primary Sponsor  
Name  Dr Rajashri Kolte  
Address  104 Department of Periodontics and Implantology VSPM Dental College and Research Centre Digdoh Hills Hingna Road Nagpur 440019 Maharashtra India  
Type of Sponsor  Other [Dr Rajashri Kolte ] 
 
Details of Secondary Sponsor  
Name  Address 
none   
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Rajashri Kolte   VSPM Dental College and Research Centre Nagpur  104 Department of Periodontics and Implantology VSPM Dental College and Research Centre Digdoh Hills Hingna Road Nagpur 440019 Maharashtra India
Nagpur
MAHARASHTRA 
9011071468

drrajashrikolte@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
VSPM Dental College and Research Centre Ethical committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Periodontally healthy males and females in age range of 20-60 years 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1.Periodontally healthy males and females between the age group of 20-60 years.
2. Patients who are willing to participate and sign the informed consent for this clinical trial.
 
 
ExclusionCriteria 
Details  1. Patients with periodontal and systemic diseases.
2. Patients with pregnancy or a history of taking medications known to increase the risk of gingival hyperplasia.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To evaluate prevalence, distribution and severity of tongue coatings according to the proposed classification of Tongue Coatings Severity Index.  Baseline 
 
Secondary Outcome  
Outcome  TimePoints 
1.To assess the prevalence of tongue coatings according to the proposed classification of Tongue Coatings Severity Index.
2.To assess the distribution of tongue coatings according to the proposed classification of Tongue Coatings Severity Index.
3.To assess the severity of tongue coatings according to the proposed classification of Tongue Coatings Severity Index.
 
3 months 
 
Target Sample Size   Total Sample Size="200"
Sample Size from India="200" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" 
Phase of Trial   N/A 
Date of First Enrollment (India)   01/03/2022 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="3"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   none 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

This study will be conducted to study the prevalence , distribution and severity of tongue coating according to the proposed classification of Tongue Coating Severity Index.

A total of 200 periodontally and systemically healthy patients with age range of 20-60 years including both male and female visiting the Department of Periodontics and implantology at VSPM Dental College and research centre Nagpur will be recruited.

A brief description of entire procedure will be given to every patient before starting procedure.

Patients will be assessed clinically and a standardised digital photograph of the dorsal surface will be taken with the tongue protruded from the oral cavity. The dorsal surface of the tongue photograph then will be marked and divided into three equal areas of anterior, middle and posterior sections as mentioned in the classification which is given as under.

Considering the limitations in the currently available indices for evaluation of tongue coating indices, we propose a simplistic method of evaluation of the same. The simple method ensures that the examiner will be easily able to calculate the tongue coating severity index in less time. This will also enable the utilisation of this scoring system on a larger population. Accordingly, the dorsal surface or the tongue will be divided into three equal parts antero-posteriorly. The surface coatings present in each of these parts will be calculated separately and then the scores of all the three parts will be added.

 
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