| CTRI Number |
CTRI/2025/03/082916 [Registered on: 20/03/2025] Trial Registered Prospectively |
| Last Modified On: |
04/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Other |
|
Public Title of Study
|
To check the blood count and value of each component before and after the gum treatment procedure in patients with gum infection. |
|
Scientific Title of Study
|
Assessment of neutrophil to lymphocyte ratio dynamics before and after periodontal therapy in stage iii periodontitis-a clinico-hematological 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 Richa Sherry |
| Designation |
Post graduate student |
| Affiliation |
Coorg Institute of Dental Sciences |
| Address |
Coorg Institute of Dental Sciences,Department of Periodontics and Implantology, Room 4, KK campus,Maggula village,Virajpet,Kodgu, Karnataka,India.Pin-571218
Kodagu
KARNATAKA
571218
India |
| Phone |
7902835018 |
| Fax |
|
| Email |
drrichasherry26@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Richa Sherry |
| Designation |
Post graduate student |
| Affiliation |
Coorg Institute of Dental Sciences |
| Address |
Coorg Institute of Dental Sciences,Department of Periodontics and Implantology, Room 4, KK campus,Maggula village,Virajpet,Kodgu, Karnataka,India.Pin-571218
Kodagu
KARNATAKA
571218
India |
| Phone |
7902835018 |
| Fax |
|
| Email |
drrichasherry26@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr.Rashmi S Pattanshetty |
| Designation |
Reader |
| Affiliation |
Coorg Institute of Dental Sciences |
| Address |
Coorg Institute of Dental Sciences,Department of Periodontics and Implantology, Room 4, KK campus,Maggula village,Virajpet,Kodgu, Karnataka,India.Pin-571218
Kodagu
KARNATAKA
571218
India |
| Phone |
9986187860 |
| Fax |
|
| Email |
rashmi2bs@gmail.com |
|
|
Source of Monetary or Material Support
|
| Coorg Institute of Dental Sciences,Department of Periodontics and Implantology, Room 4, KK campus,Maggula village,Virajpet,Kodgu, Karnataka,India.Pin-571218 |
|
|
Primary Sponsor
|
| Name |
Dr Richa Sherry |
| Address |
Coorg Institute of Dental Sciences,Department of Periodontics and Implantology, Room 4, KK campus,Maggula village,Virajpet,Kodgu, Karnataka,India.Pin-571218 |
| Type of Sponsor |
Other [[ SELF]] |
|
|
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 Richa Sherry |
Coorg Institute of Dental Sciences |
Coorg Institute of Dental Sciences,Department of Periodontics and Implantology, Room 4, KK campus,Maggula village,Virajpet,Kodgu, Karnataka,India.Pin-571218
Kodagu
KARNATAKA |
07902835018
drrichasherry26@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional review board |
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 |
| Intervention |
Periodontal therapy includes scaling ,root planing and flap surgery. |
Assessment of neutrophil to lymphocyte ratio dynamics before and after periodontal therapy in stage iii periodontitis-a clinico-hematological study. |
| Comparator Agent |
Without periodontal therapy |
Comparing neutrophil to lymphocyte ratio with and without periodontal therapy. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
1) Patients of age between 18 and 55 years
2) Patients with stage III Periodontitis.
3) Patients with radiographic evidence of bone loss
|
|
| ExclusionCriteria |
| Details |
1) Current or previous smokers and alcoholics.
2) History of periodontal therapy or antimicrobial therapy within 6 months, or history of orthodontic therapy.
3) Patients with any other systemic diseases.
4) Pregnant, menopause or lactating females.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| periodontits is associated with neutrophil to lymphocyte ratio and that periodontal therapy is able to bring down the levels . |
all clinical parameters and NLR levels will be measured at baseline,1 month after scaling and root planing and 3 month after flap surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| to estimate the NLR ratio in Stage III periodontitis before and after periodontal therapy and to evaluate their possible role as an inflammatory marker for periodontal disease. |
baseline,1 month after scaling and root planing and 3 month after flap surgery |
|
|
Target Sample Size
|
Total Sample Size="18"
Sample Size from India="18"
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)
|
12/08/2025 |
| 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="3"
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
|
This study is a clinico hematological study where 18 patients of both gender with stage 3 periodontitis, satisfying all the inclusion criteria will be enrolled for the study. This study evaluates neutrophil to lymphocyte ratio in stage 3 periodontitis patients before treatment, after scaling and root planing, and after flap surgery. Initial assessments will include a detailed case history and clinical parameters, with blood samples taken for NLR detection. Patients will receive scaling and root planing and return after 1 month for reevaluation. Those with persistent pockets will undergo flap surgery, with follow up assessments 3 months later. NLR will be compared at these 3 intervals. |