| CTRI Number |
CTRI/2025/12/098475 [Registered on: 04/12/2025] Trial Registered Prospectively |
| Last Modified On: |
03/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Role of blood cell counts in early diagnosis of gum disease and its relation to severity of gum disease. |
|
Scientific Title of Study
|
Comparative evaluation of various blood cell ratios as potential diagnostic inflammatory biomarkers of periodontal disease and their correlation with disease severity: 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 |
Sangita Agarwal |
| Designation |
Reader |
| Affiliation |
Government dental college, Raipur |
| Address |
Department of Periodontics, Government dental college and hospital, Raipur
Raipur
CHHATTISGARH
492001
India |
| Phone |
07999308410 |
| Fax |
|
| Email |
agsangs@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Mangesh Bhalchandra Phadnaik |
| Designation |
professor and head of department |
| Affiliation |
Government dental college and hospital, Nagpur |
| Address |
Department of Periodontics, Government dental college and hospital, Nagpur
MAHARASHTRA
440024
India |
| Phone |
9422254404 |
| Fax |
|
| Email |
drmbphadnaik@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Sangita Agarwal |
| Designation |
Reader |
| Affiliation |
Government dental college, Raipur |
| Address |
Department of Periodontics, Government dental college and hospital, Raipur
Raipur
CHHATTISGARH
492001
India |
| Phone |
07999308410 |
| Fax |
|
| Email |
agsangs@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government dental college and hospital Raipur 492001 (C.G.)and GDCH Nagpur 440024 Maharashtra. India |
|
|
Primary Sponsor
|
| Name |
dr sangita agarwal |
| Address |
room no 12. Department of Periodontics. GDC Raipur 492001. Chhattisgarh. India |
| Type of Sponsor |
Other [individual] |
|
|
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 Sangita Agarwal |
Government Dental College and hospital Raipur. |
Room no 12, Department of Periodontics. Rajbandha Maidan. Moudhapara. Raipur(C.G)
Raipur
CHHATTISGARH |
7999308410
agsangs@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee, GDCH Nagpur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K056||Periodontal disease, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
as per 2017 classification of periodontal disease and condition:
Grp 1. gingival health
Grp 2. gingivitis
grp 3. stage I Periodontitis
grp 4. stage II periodontitis
grp 5. stage III periodontitis
grp 6. stage IV periodontitis
|
|
| ExclusionCriteria |
| Details |
1. Patients with known systemic diseases including cancer known allergies.
2. Pregnant lactating women women in menopause.
3. Patients with immunosuppressed conditions such as systemic lupus erythematosus and rheumatoid arthritis.
4. Patients with malnutrition.
5. Periodontal therapy in the last 6 months
6. Antibiotic anti-inflammatory drug regimen before the study.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Blood cell ratios i.e. SII,SIRI,NLR, PLR will be positively correlated with periodontal disease severity assessed by clinical periodontal parameters |
at single time point only |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| age, sex, smoking, oral hygiene, BMI, SES, will be possible effect modifiers of SII, SIRI, NLR & PLR |
at single time point only |
|
|
Target Sample Size
|
Total Sample Size="499"
Sample Size from India="499"
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)
|
01/01/2026 |
| 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="1"
Months="0"
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
|
A clear relationship exists between persistent low- grade systemic inflammation and severe- advanced periodontitis (Hajishengallis 2015). An array of inflammatory biomarkers has been studied and their association with severe periodontitis has been reported. Leukocyte ratios like (Neutrophil Lymphocyte Ratio) NLR and Platelet Lymphocyte Ratio (PLR) can be considered as inflammatory biomarkers that could provide a new insight into the relationship between periodontitis and systemic diseases. SII and SIRI has been reported an effective biomarker for predicting prognosis of various kind of cancer. However, the prognostic role of these blood markers in severe periodontitis patients remains unclear. Identifying a reliable and easily obtainable inflammatory indicator would greatly facilitate the prevention and control of periodontitis. Variables such as age, gender, smoking status, alcoholism and oral hygiene habits (frequency of tooth brushing and use of other oral hygiene aids), socioeconomic status (as per revised Kuppuswamy scale 2022) to be recorded for all the participants. After that, all the subjects will undergo a standardized medical examination that included assessing height, weight, body temperature, blood pressure measurements. Body mass index (BMI) will be calculated as weight in kilograms upon height squared in meter. Clinical parameters for evaluating periodontal status will be recorded. Complete blood counts will be obtained and used for calculating SII, SIRI, NLR and PLR using a fully automated analyzer. Data obtained will be analyzed statistically. |