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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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.

 
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