| CTRI Number |
CTRI/2025/07/090220 [Registered on: 04/07/2025] Trial Registered Prospectively |
| Last Modified On: |
01/07/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Non-randomized, Multiple Arm Trial |
|
Public Title of Study
|
Glutamate levels in patients with periodontal disease and diabetes and its relation to cognition before and after ultrasonic scaling |
|
Scientific Title of Study
|
Glutamate and its relation to periodontal disease, diabetes mellitus and cognition before and after scaling and root planing -An 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 Rama P Munishwar |
| Designation |
Post Graduate |
| Affiliation |
The Oxford Dental College |
| Address |
Department of Periodontology, Room No. 3, The Oxford Dental College, 10th
milestone, Bommanahalli, Hosur Road, Bengaluru- 560068 Karnataka.
Bangalore KARNATAKA 560068 India |
| Phone |
8087274054 |
| Fax |
|
| Email |
rama.munishwar711@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Ashish S Nichani |
| Designation |
Professor |
| Affiliation |
The Oxford Dental College |
| Address |
Department of Periodontology, Room No. 3, The Oxford Dental College, 10th
milestone, Bommanahalli, Hosur Road, Bengaluru- 560068 Karnataka.
Bangalore KARNATAKA 560068 India |
| Phone |
9845252203 |
| Fax |
|
| Email |
nichaniashish@hotmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Ashish S Nichani |
| Designation |
Professor |
| Affiliation |
The Oxford Dental College |
| Address |
Department of Periodontology, Room No. 3, The Oxford Dental College, 10th
milestone, Bommanahalli, Hosur Road, Bengaluru- 560068 Karnataka.
Bangalore KARNATAKA 560068 India |
| Phone |
9845252203 |
| Fax |
|
| Email |
nichaniashish@hotmail.com |
|
|
Source of Monetary or Material Support
|
| The Oxford Dental College, Department of Periodontology, room number-03, 10th milestone,
Bommanahalli, Hosur road, Bangalore- 560068 |
|
|
Primary Sponsor
|
| Name |
Dr Rama P Munishwar |
| Address |
Department of Periodontology, Room no.3, The Oxford Dental College, 10th
milestone, Hosur Rd, Bommanahalli, Bengaluru - 560095, Karnataka. India |
| Type of Sponsor |
Other [Self Funded] |
|
|
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 Rama P Munishwar |
The Oxford Dental College |
Department of Periodontology, Room no.3, The Oxford Dental College, 10th
milestone, Hosur Rd, Bommanahalli, Bengaluru - 560095, Karnataka. India Bangalore KARNATAKA |
8087274054
rama.munishwar711@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: E119||Type 2 diabetes mellitus without complications, (2) ICD-10 Condition: K053||Chronic periodontitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NOT APPLICABLE |
NOT APPLICABLE |
| Intervention |
Scaling and root planing |
Salivary and serum glutamate levels, neuropsychological assessment and clinical parameters will be assessed at baseline and four weeks post scaling and root planing. |
|
|
Inclusion Criteria
|
| Age From |
45.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
2. Patients who have not received any periodontal treatment in previous six months.
3. Patients diagnosed with T2DM as per American Diabetes Association criteria (2019).
4. Patients with a diagnosis of generalized periodontitis as per World Workshop Classification
criteria (2017). |
|
| ExclusionCriteria |
| Details |
1. Smokers and alcoholics.
2. Patients with systemic diseases like hypertension, cardiovascular diseases, rheumatoid
arthritis, tumours, autoimmune diseases and renal diseases.
3. Pregnant and lactating females.
4. Any other systemic disease which can alter the course of periodontal disease.
5. Patients on medications like anti-inflammatory drugs, antibiotics and anti-epileptic drugs in
the past 6 months.
6. Postmenopausal women. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To correlate levels of salivary & serum glutamate in individuals with generalised periodontitis and type 2 diabetes mellitus |
At baseline and four weeks after scaling and root planing |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To evaluate the effect of scaling and root planing on glutamate and cognition |
Four weeks after scaling and root planing |
|
|
Target Sample Size
|
Total Sample Size="80" Sample Size from India="80"
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)
|
20/07/2025 |
| 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
|
Periodontal disease (PD) is the leading cause of tooth loss in adults, and it signifies long-term exposure to inflammation. Each additional tooth loss has been associated with a 1.41 percent increase in the risk of cognitive impairment. Tooth loss is associated with poor masticatory function and it may affect stimulation of the central nervous system. Limited masticatory force and chewing capacity are associated with impaired cognitive function. Evidence supports a clinical association between type 2 diabetes mellitus and PD. A chronic low-grade inflammatory state induced by type 2 diabetes mellitus may trigger worsening of periodontitis and is also an important pathophysiological mechanism underlying cognitive impairment and dementia. Decreased cognitive flexibility in diabetic individuals is well known. Glutamate, the main neurotransmitter of the central nervous system, is a non-essential amino acid. It plays a key role in the development and function of normal brain activity, is a key factor involved in memory and learning and is also a promising marker of metabolic dysfunction. When glutamate concentrations are low in the brain there is poorer performance in several cognitive tests like the trail making tests (TMT A & B). Glutamate also has a pivotal role in transamination reaction that further upregulates in proteolysis and gets accelerated in chronic periodontitis during collagen destruction. Circulating glutamate has also shown to increase in diabetic individuals and is a strong predictor of waist circumference (WC). Periodontal treatment reduces systemic inflammation and exposure to Porphyromonas gingivalis. This can improve insulin resistance which has been linked to the development of type 2 diabetes mellitus & might also reduce or delay the development of cognitive decline. Scaling and root planing (SRP) is the most commonly performed procedure for the treatment of periodontitis. We therefore hypothesized, that periodontitis, if positively associated with type 2 diabetes mellitus & cognition, SRP could lead to improvement in cognition and influence glutamate levels. Till date, the role of glutamate in the pathologic processes linking PD, diabetes mellitus & cognition is unclear. Hence the aim of this study is to correlate levels of salivary & serum glutamate in individuals with generalized periodontitis and type 2 diabetes mellitus & to evaluate the effect of SRP on glutamate and cognition. |