| CTRI Number |
CTRI/2025/12/099304 [Registered on: 17/12/2025] Trial Registered Prospectively |
| Last Modified On: |
16/12/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Association between Dental status and cognitive domain assessed using Psychiatry Scales in adult population: A cross-sectional study. |
|
Scientific Title of Study
|
Association of Periodontal Status and cognitive domain assessed using Minimal Mental State Examination and Montreal Cognitive Examination Scales in Adult population: A Cross-Sectional Study. |
| Trial Acronym |
NIL |
|
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 |
Ranjeet Deshmukh Dental College and Research Centre, Nagpur |
| Address |
104 Department of Periodontics and Implant Dentistry
Ranjeet Deshmukh Dental College and Research Centre
Nagpur
MAHARASHTRA
440019
India |
| Phone |
09011071468 |
| Fax |
|
| Email |
drrajashrikolte@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rajashri Kolte |
| Designation |
Professor and Guide |
| Affiliation |
Ranjeet Deshmukh Dental College and Research Centre, Nagpur |
| Address |
104 Department of Periodontics and Implant Dentistry
Ranjeet Deshmukh Dental College and Research Centre
MAHARASHTRA
440019
India |
| Phone |
09011071468 |
| Fax |
|
| Email |
drrajashrikolte@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rajashri Kolte |
| Designation |
Professor and Guide |
| Affiliation |
Ranjeet Deshmukh Dental College and Research Centre, Nagpur |
| Address |
104 Department of Periodontics and Implant Dentistry
Ranjeet Deshmukh Dental College and Research Centre
MAHARASHTRA
440019
India |
| Phone |
09011071468 |
| Fax |
|
| Email |
drrajashrikolte@gmail.com |
|
|
Source of Monetary or Material Support
|
| Ranjeet Deshmukh Dental College and Research Centre Nagpur |
|
|
Primary Sponsor
|
| Name |
None |
| Address |
None |
| 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 |
| Rajashri Kolte |
Ranjeet Deshmukh Dental College and Research Centre Nagpur 440019 |
104 Department of Periodontics and Implant Dentistry
Ranjeet Deshmukh Dental College and Research Centre
Digdoh Hills Hingna road Nagpur 440019
Nagpur
MAHARASHTRA |
09011071468
drrajashrikolte@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F69||Unspecified disorder of adult personality and behavior, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1. Adults aged 18 years and above.
2. Patients with varying degrees of cognitive function, including normal cognition, mild cognitive impairment, and diagnosed dementia.
3. Presence of more than 15 natural teeth
4. Ability to provide informed consent or availability of a legally authorized representative to provide consent.
5. Willingness to participate and undergo cognitive and periodontal examinations.
|
|
| ExclusionCriteria |
| Details |
1. Pregnant or lactating females.
2. Completely edentulous patients.
3. Patients on medications or conditions known to affect cognition independently.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To explore association between periodontal status and cognitive domain using Minimal Mental State Examination and Montreal Cognitive Examination Scales in adult population. |
Baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To evaluate periodontal status of the patients through parameters of probing depth, full mouth bleeding scores and clinical attachment level.
2. To assess cognitive domain with the use of Minimal Mental State Examination and Montreal Cognitive Examination Scales.
|
Baseline |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
27/12/2025 |
| 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)
|
Suspended |
| Recruitment Status of Trial (India) |
Suspended |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The procedure will involve a comprehensive oral health
examination of the patients, including detailed assessment of their periodontal
status using standardized clinical parameters. Cognitive function will be
evaluated using two validated scales: the Montreal Cognitive Assessment (MoCA)
and the Mini-Mental State Examination (MMSE). The results of oral and
periodontal examinations and cognitive assessments will be analyzed to explore
the interrelationship between periodontal status and cognitive functions in the
adult population. |