| 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
|
|
|
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
|
|
|
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
|
|
|
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. |