| CTRI Number |
CTRI/2021/07/034799 [Registered on: 13/07/2021] Trial Registered Prospectively |
| Last Modified On: |
09/07/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Association of fingerprint patterns with oral diseases |
|
Scientific Title of Study
|
Association of fingerprint patterns with periodontal disease among patients visiting a dental clinic |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Pratibha G |
| Designation |
Professor |
| Affiliation |
Manipal College of Dental Sciences, Manipal |
| Address |
Room no 3 Department of Periodontology MCODS Manipal, Karnataka
Udupi
KARNATAKA
576104
India |
| Phone |
9448724121 |
| Fax |
|
| Email |
pratibha.pk@manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pratibha G |
| Designation |
Professor |
| Affiliation |
Manipal College of Dental Sciences, Manipal |
| Address |
Room no 3 Department of Periodontology MCODS Manipal, Karnataka
Udupi
KARNATAKA
576104
India |
| Phone |
9448724121 |
| Fax |
|
| Email |
pratibha.pk@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pratibha G |
| Designation |
Professor |
| Affiliation |
Manipal College of Dental Sciences, Manipal |
| Address |
Room no 3 Department of Periodontology MCODS Manipal, Karnataka
Udupi
KARNATAKA
576104
India |
| Phone |
9448724121 |
| Fax |
|
| Email |
pratibha.pk@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Manipal College of Dental Sciences, Manipal |
|
|
Primary Sponsor
|
| Name |
Dr Rohit Kapur |
| Address |
Room no 3 Department of Periodontology, Manipal College of Dental Sciences, Manipal |
| Type of Sponsor |
Other [Self] |
|
|
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 Rohit Kapur |
Manipal College of Dental Sciences, Manipal |
Room no 3 Department of Periodontology,Ground Floor
Udupi
KARNATAKA |
7508566614
rkgk12345678@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:K056||Periodontal disease, unspecified. Ayurveda Condition: Upakusha, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients with age between 18-60 years
Controlled diabetes
|
|
| ExclusionCriteria |
| Details |
Uncooperative and unwilling
Pregnant and/ or lactating women
Severe medical compromise- Any history of cardiovascular diseases, respiratory disease,
Hypertensives
Injury to hand / finger
Absence / Amputation of a digit
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Co relation between periodontal diseases and fingerprint patterns |
2 Years |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Evaluation of periodontal status of the patient and co relating each parameter with the fingerprint pattern |
2 Years |
|
|
Target Sample Size
|
Total Sample Size="75"
Sample Size from India="75"
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)
|
15/07/2021 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
For the study, ethical
approval would be obtained from the Kasturba hospital ethics Committee.
An
observational study will be conducted on all patients visiting the Dental
clinics. All patients will be screened at the Dept. of Oral Medicine for
recruitment into the study based on the inclusion and exclusion criteria, and a
convenience sampling method will be followed for recruitment. Sample size of 75
will be taken in this study. The purpose of the study will be explained to the
participants, informing them of anonymity and confidentiality, and receiving
written consent from the subjects.
The
patient will be recruited after the patient information and consent followed by
evaluation of periodontal status, after which the finger ridge pattern will be
taken.
Initially,
finger ridge patterns of all fingers from both left and right hands would be
captured using standard ink method for assessment. The
fingers will be cleaned and dried before taking the fingerprint. The
fingerprint will be recorded on a fingerprint recording format.
All
patients would then undergo evaluation of periodontal status by a trained examiner
(Principal student
researcher under the guidance of Principal Investigator) The periodontal status will be evaluated using the 2017 classification of Periodontal and Peri-Implant
Diseases and Conditions. Staging and grading of periodontitis will be done
to categorize the patients.
A clinical
proforma will be used for recording the various parameters that comprise the
classification system, which include
1. Probing pocket depth
2. Probing attachment loss
3. Bleeding on Probing
4. Radiological bone loss
5. Interdental Clinical attachment level
6. Tooth loss
7. Furcation involvement
8. Ridge defect
9. Bite collapse
10. Drifting
11. Flaring
12. Presence of biofilm
13. Smoking
14. Diabetes
15. Endo-perio lesions
16. Periodontal abscess
17. Gingival Recession
18. Occlusal trauma
The finger - prints obtained would then be coded for subsequent
manual evaluation of finger ridge patterns by the Dept. of Forensic medicine.
The obtained data will be statistically analyzed for distribution
of finger ridge patterns among the various categories of periodontitis patients
as obtained by the 2017 classification of periodontal diseases. Furthermore, a
secondary outcome will be to determine any association between periodontal
disease and finger ridge patterns.
Stage
I- Initial Periodontitis
Stage
II- Moderate Periodontitis
Stage
III- Severe Periodontitis with potential for additional tooth loss
Stage
IV- Severe Periodontitis with potential for loss of the dentition
|