| CTRI Number |
CTRI/2023/10/059333 [Registered on: 31/10/2023] Trial Registered Prospectively |
| Last Modified On: |
30/10/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Non-randomized, Multiple Arm Trial |
|
Public Title of Study
|
Evaluation of blood cell ratios in periodontitis patients with and without Type 2 Diabetes Mellitus Before and one month after scaling and root planing |
|
Scientific Title of Study
|
Evaluation of Neutrophil to Lymphocyte (NLR),Platelet to lymphocyte (PLR) and Lymphocyte to Monocyte (LMR) ratios in peripheral blood of patients having periodontitis with type 2 diabetes mellitus before and one month after scaling and root planing |
| 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 Vishnudas Bhandari |
| Designation |
HOD and professor |
| Affiliation |
Maharashtra Institute of Dental Sciences and Research Latur |
| Address |
Room no -10 First floor, Department of Periodontology and Implantology, Maharashtra institute of dental sciences and research Latur.
Latur
MAHARASHTRA
413512
India |
| Phone |
9823525229 |
| Fax |
|
| Email |
vishnudas.bhandari@mitmidsr.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Nikita Vikasrao Palkar |
| Designation |
PG student |
| Affiliation |
Maharashtra Institute of Dental Sciences and Research Latur |
| Address |
Room no -10 First floor, Department of Periodontology and Implantology, Maharashtra institute of dental sciences and research Latur.
Latur
MAHARASHTRA
413512
India |
| Phone |
9975256390 |
| Fax |
|
| Email |
nikkipalkar95@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vishnudas Bhandari |
| Designation |
HOD and professor |
| Affiliation |
Maharashtra Institute of Dental Sciences and Research Latur |
| Address |
Room no -10 First floor, Department of Periodontology and Implantology, Maharashtra institute of dental sciences and research Latur.
Latur
MAHARASHTRA
413512
India |
| Phone |
9823525229 |
| Fax |
|
| Email |
vishnudas.bhandari@mitmidsr.edu.in |
|
|
Source of Monetary or Material Support
|
| Self supported by (Dr. Nikita Vikasrao Palkar and Dr. Vishnudas Bhandari). Monetary support from Maharashtra Institute of Dental Sciences and Research Dental College Latur. |
|
|
Primary Sponsor
|
| Name |
Dr. Nikita Vikasrao Palkar |
| Address |
Room No. 10 first floor, Department of Periodontology and Implantology, Maharashtra Institute of Dental Sciences and Research Dental College, Latur. |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr Vishnudas Bhandari |
Room No. 10 first floor, Department of Periodontology and Implantology, Maharashtra Institute of Dental Sciences and Research Dental College, Latur. |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Vishnudas Bhandari |
Maharashtra Institute of Dental Sciences and Research Dental College, Latur |
Room no. 10 first floor, Department of Periodontology and Implantology, Maharashtra Institute of Dental Sciences and Research Dental College, Latur
Latur
MAHARASHTRA |
9823525229
vishnudas.bhandari@mitmidsr.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics committee for Human Research MIDSR dental college , Latur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
periodontitis patients with or without diabetes mellitus |
| Patients |
(1) ICD-10 Condition: K053||Chronic periodontitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Healthy participants, participants with periodontitis, and participants with periodontitis plus diabetes mellitus |
measuring blood cell ratios at baseline that is twice in one month |
| Intervention |
Healthy participants, participants with periodontitis, and participants with periodontitis plus diabetes mellitus treated with mechanical periodontal therapy |
measuring blood cell ratios after one month of mechanical periodontal therapy that is twice in one month |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Group A
1.Subjects with clinically healthy periodontium, with no attachment loss and probing depth of less than or equal to 3 mm, <10%bleeding sites, subject with gingival index score of maximum up to <1, included which were considered to be relatively healthy and subject having HbA1c level between 4%–6% considered as control group.
2.Group B:
1.Patients with Periodontitis stage II and stage III as per the 2017 American Academy of Periodontology Classification.
2.Patients with periodontitis stage II having clinical attachment loss of 3-4mm and maximum probing pocket depth ≤5 mm.
3.Patients with periodontitis stage III having clinical attachment loss of ≥5 mm and maximum probing pocket depth ≥ 6mm.35
3.Group C:
1.Patients with periodontitis (stage II and stage III as per the 2017 American Academy of Periodontology classification) with diagnosed case of type 2 diabetes mellitus (Good diabetes control, HbA1c level 7%)
|
|
| ExclusionCriteria |
| Details |
1.Patient refusal
2.Patient who has received periodontal treatment in last 6months.
3.Patient who is smoker or consuming any other form of tobacco.
4.Pregnant, lactating or postmenopausal women.
5.Hospitalized patients.
6.Subjects consuming antibiotic or other drugs in the past 6 months that affect their periodontal status.
7.History of any systemic disease which influences the values of NLR, PLR, and LMR ratio like any malignancy, cardiovascular diseases, rheumatic diseases, bipolar disorder, thyrotoxicosis, psoriasis other than type 2 diabetes mellitus for the test group (Group III)
8.History of any systemic disease for the control group.
9.If subject cannot maintain oral hygiene after non-surgical periodontal therapy (Gingival index score >1, plaque index>1).
|
|
|
Method of Generating Random Sequence
|
Adaptive randomization, such as minimization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| changes in blood cell ratios |
one month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Plaque index ,gingival index, probing pocket depth |
one month |
|
|
Target Sample Size
|
Total Sample Size="63"
Sample Size from India="63"
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)
|
25/11/2023 |
| 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="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
|
NLR,PLR,LMR ratios is useful in the prediction and the detection of inflammatory and infectious conditions, and their postoperative complications. They also reflects the degree of systemic inflammation, can be consider as prognostic markers. Hence this study is focused on analysis of the blood cell ratios in periodontitis patients with and without diabetes mellitus before and after scaling and root planing. |