| CTRI Number |
CTRI/2024/03/064169 [Registered on: 14/03/2024] Trial Registered Prospectively |
| Last Modified On: |
14/03/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Comparison of ratio of blood components in pyorrhea patients before and after treatment. |
|
Scientific Title of Study
|
Comparative evaluation of Neutrophil-to- Lymphocyte Ratio (NLR) and Platelet to Lymphocyte Ratio (PLR) in chronic periodontitis patients before and after surgical periodontal therapy- An interventional 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 |
SURABHI TANDEL |
| Designation |
PG STUDENT |
| Affiliation |
DR HSRSM DENTAL COLLEGE AND HOSPITAL, HINGOLI |
| Address |
Room Number 15, Department of Periodontics,
Dr HSRSM Dental College and Hospital, Basamba Phata, Akola Road, Hingoli.
Room Number 15, Department of Periodontics,
Dr HSRSM Dental College and Hospital, Basamba Phata, Akola Road, Hingoli.
Hingoli
MAHARASHTRA
431513
India |
| Phone |
9930125665 |
| Fax |
|
| Email |
drsurabhiperio@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR ANUP U SHELKE |
| Designation |
PROFESSOR |
| Affiliation |
DR HSRSM DENTAL COLLEGE AND HOSPITAL, HINGOLI |
| Address |
Room Number 15, Department of Periodontics,
Dr HSRSM Dental College and Hospital, Basamba Phata, Akola Road, Hingoli.
Room Number 15, Department of Periodontics,
Dr HSRSM Dental College and Hospital, Basamba Phata, Akola Road, Hingoli.
Hingoli
MAHARASHTRA
431513
India |
| Phone |
9890395919 |
| Fax |
|
| Email |
dranup001@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR ANUP U SHELKE |
| Designation |
PROFESSOR |
| Affiliation |
DR HSRSM DENTAL COLLEGE AND HOSPITAL, HINGOLI |
| Address |
Room Number 15, Department of Periodontics,
Dr HSRSM Dental College and Hospital, Basamba Phata, Akola Road, Hingoli.
Hingoli
MAHARASHTRA
431513
India |
| Phone |
9890395919 |
| Fax |
|
| Email |
dranup001@gmail.com |
|
|
Source of Monetary or Material Support
|
| DR HSRSM DENTAL COLLEGE AND HOSPITAL, HINGOLI |
|
|
Primary Sponsor
|
| Name |
DR SURABHI TANDEL |
| Address |
Room Number 15, Department of Periodontics,
Dr HSRSM Dental College and Hospital, Basamba Phata, Akola Road, Hingoli. |
| 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 SURABHI TANDEL |
DR HSRSM DENTAL COLLEGE AND HOSPITAL |
ROOM NO. 15,DEPARTMENT OF PERIODONTICS,DR HSRSM DENTAL COLLEGE AND HOSPITAL, BASAMBA PHATA, AKOLA ROAD
Hingoli
MAHARASHTRA |
9930125665
drsurabhiperio@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| DR HSRSM DENTAL COLLEGE HINGOLI |
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 |
| Comparator Agent |
NIL |
NIL |
| Intervention |
Periodontal Flap Surgery. Comparator agent not applicable for single arm study. |
Plaque index, Gingival index, Modified sulcus bleeding index,
Probing pocket depth, Clinical Attachment Level, Neutrophil to Lymphocyte ratio and Platelet to
Lymphocyte ratio will be evaluated at baseline. After Scaling and root planing, patient is reevaluated after 4 weeks for periodontal status. If Stage three periodontitis persists Periodontal Flap surgery is performed.
Local anesthesia is administered and the mucoperiosteal flap is elevated using the required flap design. Debridement of the surgical area is done using curettes and ultrasonic scalers. Sutures are placed for closure of the flap. Patient is recalled after 7 days for suture removal. Plaque index, Gingival index, Modified sulcus bleeding index,
Probing pocket depth, Clinical Attachment Level, Neutrophil to Lymphocyte ratio and Platelet to
Lymphocyte ratio will be evaluated after 6 weeks. Time of intervention is 10 weeks. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
Minimum of 20 teeth to be present in every patient and minimum 4 teeth present in each quadrant
Cases of stage three periodontitis CAL greater than or equal to 5mm and PPD greater than or equal to 6mm |
|
| ExclusionCriteria |
| Details |
Patients suffering from known systemic diseases and known allergy
Pregnant, lactating and menopause female patients
Patients with habit of any form of tobacco
Patients who have received any antibiotic and or anti-inflammatory drug therapy during past 3 months
Patients who received surgical or nonsurgical periodontal therapy in last 6 months
Patients with autoimmune diseases
Patients with any systemic/ hematologic disorder
Patients with history of fever in last 1 month
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change in Neutrophil to Lymphocyte ratio and Platelet to Lymphocyte ratio after surgical periodontal therapy in chronic periodontitis patients |
10 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Change in Plaque index (PI) (Silness & Loe, 1964)
Gingival Index (GI) (Loe & Silness, 1963)
Modified Sulcus Bleeding Index (Mombelli et al, 1987)
PROBING POCKET DEPTH(PPD)
CLINICAL ATTACHMENT LEVEL(CAL)
|
10 weeks |
|
|
Target Sample Size
|
Total Sample Size="104"
Sample Size from India="104"
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
|
Phase 2 |
|
Date of First Enrollment (India)
|
25/03/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
25/03/2024 |
| 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
|
The sample size for the study is 104 individuals out of which 52 are present in test and control groups each. Test group consists of stage three periodontitis patient and control group consists of periodontally healthy individuals. Plaque index, Gingival index, Modified sulcus bleeding index, Probing pocket depth, Clinical Attachment Level, Neutrophil to Lymphocyte ratio and Platelet to Lymphocyte ratio will be evaluated at baseline for both the groups and after 10 weeks for test group. |