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DNI Values After Periodontal Treatment

Primary Purpose

Periodontitis, Periodontal Inflammation, Inflammatory Response

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Only routine non-surgical periodontal treatment was applied to the patients.
Sponsored by
Kahramanmaras Sutcu Imam University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Periodontitis

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Patients diagnosed with periodontitis, Must have more than 20 teeth in the mouth, be between the ages of 18-65 Exclusion Criteria: Patients were excluded from the study if they had any systemic disease, were active smokers, were pregnant or breastfeeding, had used any antibiotic or anti-inflammatory drug in the last 6 months, had received any periodontal treatment in the last 6 months.

Sites / Locations

  • Kahramanmaraş Sütçü İmam University

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Kahramanmaraş Sütçü İmam University

Arm Description

Only routine non-surgical periodontal treatment was applied to the patients.

Outcomes

Primary Outcome Measures

Can Delta Neutrophil Index values predict the success of periodontal treatment in patients with periodontitis
We expect a decrease in the Delta Neutrophil Index values after non-surgical periodontal treatment.

Secondary Outcome Measures

Neutrophil-lymphocyte ratio (NLR) values after non-surgical periodontal treatment.
We expect a decrease in the neutrophil-lymphocyte ratio (NLR) values after non-surgical periodontal treatment.

Full Information

First Posted
December 9, 2022
Last Updated
December 18, 2022
Sponsor
Kahramanmaras Sutcu Imam University
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1. Study Identification

Unique Protocol Identification Number
NCT05666622
Brief Title
DNI Values After Periodontal Treatment
Official Title
Can Delta Neutrophil Index Values Predict the Success of Periodontal Treatment in Patients With Periodontitis?
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
October 1, 2020 (Actual)
Primary Completion Date
July 1, 2021 (Actual)
Study Completion Date
January 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kahramanmaras Sutcu Imam University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
The study included 70 systemically healthy individuals, as a test group of 35 patients with Stage 3, Grade A periodontitis and a control group of 35 individuals with no periodontal disease. Blood samples were taken for the examination of DNI, white blood cells (WBC), immature granulocytes (IG), procalcitonin, C-reactive protein (CRP), lymphocyte count and neutrophil count. For the patients with periodontitis, blood sample assays were repeated 3 months after NSPT.
Detailed Description
The role of the Delta Neutrophil Index (DNI) in the pathogenesis and follow-up of periodontal disease has not been comprehensively documented. The study included 70 systemically healthy individuals, as a test group of 35 patients with Stage 3, Grade A periodontitis and a control group of 35 individuals with no periodontal disease. Blood samples were taken for the examination of DNI, white blood cells (WBC), immature granulocytes (IG), procalcitonin, C-reactive protein (CRP), lymphocyte count and neutrophil count. For the patients with periodontitis, blood sample assays were repeated 3 months after NSPT.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Periodontitis, Periodontal Inflammation, Inflammatory Response

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
70 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Kahramanmaraş Sütçü İmam University
Arm Type
Other
Arm Description
Only routine non-surgical periodontal treatment was applied to the patients.
Intervention Type
Other
Intervention Name(s)
Only routine non-surgical periodontal treatment was applied to the patients.
Intervention Description
The study included 70 systemically healthy individuals, as a test group of 35 patients with Stage 3, Grade A periodontitis and a control group of 35 individuals with no periodontal disease. Blood samples were taken for the examination of DNI, white blood cells (WBC), immature granulocytes (IG), procalcitonin, C-reactive protein (CRP), lymphocyte count and neutrophil count. For the patients with periodontitis, blood sample assays were repeated 3 months after non-surgical periodontal treatment
Primary Outcome Measure Information:
Title
Can Delta Neutrophil Index values predict the success of periodontal treatment in patients with periodontitis
Description
We expect a decrease in the Delta Neutrophil Index values after non-surgical periodontal treatment.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Neutrophil-lymphocyte ratio (NLR) values after non-surgical periodontal treatment.
Description
We expect a decrease in the neutrophil-lymphocyte ratio (NLR) values after non-surgical periodontal treatment.
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Patients diagnosed with periodontitis, Must have more than 20 teeth in the mouth, be between the ages of 18-65 Exclusion Criteria: Patients were excluded from the study if they had any systemic disease, were active smokers, were pregnant or breastfeeding, had used any antibiotic or anti-inflammatory drug in the last 6 months, had received any periodontal treatment in the last 6 months.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eda Çetin Özdemir, Dr.
Organizational Affiliation
Kahramanmaraş sütçü İmam University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kahramanmaraş Sütçü İmam University
City
Kahramanmaraş
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
26252399
Citation
Roberts FA, Darveau RP. Microbial protection and virulence in periodontal tissue as a function of polymicrobial communities: symbiosis and dysbiosis. Periodontol 2000. 2015 Oct;69(1):18-27. doi: 10.1111/prd.12087.
Results Reference
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PubMed Identifier
25534621
Citation
Hajishengallis G. Periodontitis: from microbial immune subversion to systemic inflammation. Nat Rev Immunol. 2015 Jan;15(1):30-44. doi: 10.1038/nri3785.
Results Reference
background
PubMed Identifier
33510490
Citation
Hajishengallis G, Chavakis T. Local and systemic mechanisms linking periodontal disease and inflammatory comorbidities. Nat Rev Immunol. 2021 Jul;21(7):426-440. doi: 10.1038/s41577-020-00488-6. Epub 2021 Jan 28.
Results Reference
background
PubMed Identifier
31543614
Citation
Acharya AB, Shetty IP, Jain S, Padakannaya I, Acharya S, Shettar L, Thakur S. Neutrophil-to-lymphocyte ratio and platelet-to-lymphocyte ratio in chronic periodontitis before and after nonsurgical therapy. J Indian Soc Periodontol. 2019 Sep-Oct;23(5):419-423. doi: 10.4103/jisp.jisp_622_18.
Results Reference
background
PubMed Identifier
35060836
Citation
Valiyaveetil Karattil L, Joseph RS, Ambooken M, Mathew JJ. Evaluation of serum concentrations of hs-CRP and Hb in varying severities of chronic periodontitis. Biomarkers. 2022 May;27(3):258-263. doi: 10.1080/1354750X.2022.2032349. Epub 2022 Feb 2.
Results Reference
background
PubMed Identifier
23482854
Citation
Yoon NB, Son C, Um SJ. Role of the neutrophil-lymphocyte count ratio in the differential diagnosis between pulmonary tuberculosis and bacterial community-acquired pneumonia. Ann Lab Med. 2013 Mar;33(2):105-10. doi: 10.3343/alm.2013.33.2.105. Epub 2013 Feb 21.
Results Reference
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DNI Values After Periodontal Treatment

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