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CTRI Number  CTRI/2026/01/100511 [Registered on: 07/01/2026] Trial Registered Prospectively
Last Modified On: 07/01/2026
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   A Study to Assess Stress Levels in Patients With Gum Disease With and Without Other Medical Conditions 
Scientific Title of Study   Association of psychological distress in patients of Stage III/IV periodontitis with and without chronic systemic conditions: A cross-sectional analytical 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. Abhay Kolte 
Designation  Dean, Hod and Guide 
Affiliation  Ranjeet Deshmukh Dental College and Research Centre, Digdoh Hills, Hingna Road, Nagpur  
Address  104 Department of periodontics and implantology Ranjeet Deshmukh Dental College and Research Centre Digdoh Hills Hingna Road Nagpur

Nagpur
MAHARASHTRA
440019
India 
Phone  9011071467  
Fax    
Email  drabhaypkolte@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr . Abhay kolte 
Designation  Dean , Hod and Guide 
Affiliation  Ranjeet Deshmukh Dental College and Research Centre Digdoh Hills Hingna Road Nagpur  
Address  104 Department of periodontics and implantology Ranjeet Deshmukh Dental College and Research Centre Digdoh Hills Hingna Road Nagpur

Nagpur
MAHARASHTRA
440019
India 
Phone  9011071467  
Fax    
Email  drabhaypkolte@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr. Abhay Kolte 
Designation  Dean, Hod and Guide 
Affiliation  Ranjeet Deshmukh Dental College and Research Centre Digdoh Hills Hingna Road Nagpur  
Address  104 Department of Periodontics and Implantology Ranjeet Deshmukh Dental College and Research Centre Digdoh Hills Hingna Road Nagpur

Nagpur
MAHARASHTRA
440019
India 
Phone  9011071467  
Fax    
Email  drabhaypkolte@gmail.com  
 
Source of Monetary or Material Support  
104 Department of Periodontics and Implantology Ranjeet Deshmukh Dental College and Research Centre Digdoh Hills Hingna Road Nagpur India - 440019  
 
Primary Sponsor  
Name  NONE 
Address  NONE 
Type of Sponsor  Other [SELF] 
 
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 Abhay Kolte  Ranjeet Deshmukh Dental College and Research Centre  104 Department of Periodontics and Implantology ,Digdoh Hills, Hingna Road,Nagpur - 440019
Nagpur
MAHARASHTRA 		 9011071467

drabhaypkolte@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: K053||Chronic periodontitis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  The patients who are above 18 yrs of age stage three and four periodontitis patients as assessed by criteria of world workshop on the classification of periodontal and peri implant diseases 2017 that is disease affecting more than 30 persent of the teeth with clinical attachment level greater than equal to 5 mm and probing pocket depth greater than equal to 6 mm patients without serious medical or mental condition patients willing to undergo clinical oral examination and give medical history patients able to understand and respond to questionnaire and patients who provided written consent form were included in the study 
 
ExclusionCriteria 
Details  1) Children, adolescents, individuals with significant medical or psychiatric conditions, and
2) Patients who were unwilling to participate were excluded from the study.
3) Patients who had undergone dental treatment in the past six months.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To evaluate the association of psychological distress in patients of Stage III/IV periodontitis with and without chronic systemic conditions.  Baseline 
 
Secondary Outcome  
Outcome  TimePoints 
To assess psychological distress in patients with Stage III/IV periodontitis without chronic systemic condition through
1. General Health Questionnaire12 (GHQ-12).
2. List of Threatening Events (LTE) self-reported questionnaire.
3. Oslo Social Support Scale (OSSS-3).
4.To assess psychological distress in patients with Stage III/IV periodontitis with chronic systemic condition through the above mentioned scales.
5.To compare psychological distress in patients with Stage III/IV periodontitis with & without chronic systemic condition.
 		 Baseline 
 
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)   20/01/2026 
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 Yet Recruiting 
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   This cross-sectional analytical study evaluates the association between psychological distress and Stage III/IV periodontitis in patients with and without chronic systemic conditions. Eighty adults are divided into two groups based on the presence of systemic disease. Psychological distress is assessed using GHQ-12, List of Threatening Events, and Oslo Social Support Scale, while periodontal status is evaluated through standard clinical parameters. Statistical analysis compares distress levels between groups and explores correlations with periodontal severity. The study aims to clarify the interrelationship between severe periodontitis, systemic conditions, and psychological distress, contributing evidence for integrated periodontal and mental health management. 
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