| CTRI Number |
CTRI/2025/02/079969 [Registered on: 06/02/2025] Trial Registered Prospectively |
| Last Modified On: |
01/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Correlation between Alzheimers and Periodontitis |
| Study Design |
Other |
|
Public Title of Study
|
Result of alzheimers and vascular Dementia on Periodonatal health and cathepsin K levels |
|
Scientific Title of Study
|
Effect of alzheimer’s and vascular dementia on periodontitis and cathepsin k levels - a comparative observational 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 VEERENDRA NATH REDDY |
| Designation |
PROFESSOR |
| Affiliation |
Panineeya Mahavidyala Institute of Dental sciences and research centre |
| Address |
Room no 101, Department of periodontics , Panineeya Mahavidyalaya Institute of Dental Sciences and Research centre,road no 5, kamalanagar Dilsukhnagar, Hyderabad.
Hyderabad
TELANGANA
500060
India |
| Phone |
9866199902 |
| Fax |
|
| Email |
veerureddy@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr VEERENDRA NATH REDDY |
| Designation |
PROFESSOR |
| Affiliation |
Panineeya Mahavidyala Institute of Dental sciences and research centre |
| Address |
Room no 101, Department of periodontics , Panineeya Mahavidyalaya Institute of Dental Sciences and Research centre,road no 5, kamalanagar Dilsukhnagar, Hyderabad.
Hyderabad
TELANGANA
500060
India |
| Phone |
9866199902 |
| Fax |
|
| Email |
veerureddy@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
MIR SUHAILUDDIN |
| Designation |
Post Graduate |
| Affiliation |
Panineeya Mahavidyala Institute of Dental sciences and research centre |
| Address |
Room no 101, Department of periodontics , PanineeyaMahavidyalaya Institute of Dental Sciences and Research centre,road no 5, kamalanagar Dilsukhnagar, Hyderabad.
Hyderabad
TELANGANA
500060
India |
| Phone |
8125500957 |
| Fax |
|
| Email |
shivani.kajal1@gmail.com |
|
|
Source of Monetary or Material Support
|
| Panineeya Mahavidyalaya Institute of Dental Sciences and Research centre,road no 5, kamalanagar Dilsukhnagar, Hyderabad.TELANGANA
500060
India
|
|
|
Primary Sponsor
|
| Name |
Panineeya Mahavidyalaya Institute of Dental Sciences and research centre |
| Address |
Road no 5, kamala nagar Dilsukhnagar, Hyderabad Telangana 500065 India
|
| Type of Sponsor |
Research institution and hospital |
|
|
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 MIR SUHAILUDDIN |
Panineeya Mahavidyalaya Institute of Dental Sciences and research centre |
Room no 101, Department of periodontics,road no 5, kamalanagar Dilsukhnagar, Hyderabad.
Hyderabad
TELANGANA |
8125500957
shivani.kajal1@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committe |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K053||Chronic periodontitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
GROUP 1-30 Patients with Alzheimers type of dementia
|
In alzheimers dementia patients 2 ml of blood will be collected with a 2 ml syringe and serum will be extracted from blood with centrifugation at 3500 rpm and samples are stored and ELISA test will be performed to evaluate cathepsin K levels.
The Clinical parameters Probing Pocket depth and Cliical attacment level will be recorded using UNC 15 Probe.
Radiological assessment of bone levels will be done with an orthopantomograph.
|
| Comparator Agent |
GROUP 2-30 Patients with Vascular dementia
|
In Vascular dementia patients, 2 ml of blood will be collected with a 2 ml syringe and serum will be extracted from blood with centrifugation at 3500 rpm and samples are stored and ELISA test will be performed to evaluate cathepsin K levels.
The Clinical parameters Probing Pocket depth and Cliical attacment level will be recorded using UNC 15 Probe.
Radiological assessment of bone levels will be done with an orthopantomograph.
|
|
|
Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1.Male & female Patients aged more than 35 years
2.Patients having cognitive dysfunction
|
|
| ExclusionCriteria |
|
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Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Cathapsin k levels in serum |
baseline and 1 month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Probing pocket depth PPD
Clinical attachment level CAL
Full mouth x-ray OPG |
6 months |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
18/02/2025 |
| 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)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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
|
• Dementia is mostly caused by aging and is one of the most serious social health issues in developed world Dementia is a condition that affects memory and cognitive function, and it can have an impact on oral health. When someone has dementia, they may have difficulty maintaining good oral hygiene, which can lead to gum disease and periodontal bone loss. Additionally, the inflammation caused by gum disease can worsen cognitive decline in individuals with dementia. It’s important for care givers to help with oral care to minimize the risk of periodontal bone loss. ALZHEIMER’S TYPE OF DEMENTIA: it is the most common form of dementia. It is characterized by the accumulation of abnormal proteins in the brain, which leads to death of brain cells and gradual decline of cognitive function. People with Alzheimer’s often experience memory loss , confusion, and difficulty with daily tasks. VASCULAR DEMENTIA: On the other hand, it occurs when there is damage to the blood vessels in the brain. This can be caused by conditions like stroke or high blood pressure. The symptoms of vascular dementia can vary depending on the location and severity of the damage, but they often include problems with thinking, memory, and decision-making. CATHEPSIN K BIOMARKER: It is an enzyme that plays a role in bone remodeling and degradation. It is primarily found in osteoclasts, which are cells responsible for breaking down and resorbing bone tissues. Elevated levels of cathepsin k in blood or urine samples may indicate increased bone resorption and potential bone loss. |