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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05666622
Other study ID # 2020/18-05
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 1, 2020
Est. completion date January 1, 2022

Study information

Verified date January 2024
Source Kahramanmaras Sutcu Imam University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 70
Est. completion date January 1, 2022
Est. primary completion date July 1, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria: - Patients diagnosed with periodontitis - Patients have more than 20 teeth in the mouth - Minimum age 18 - Maximum age 65 Exclusion Criteria: - Patients with any systemic disease - Active smokers - Pregnant or breastfeeding - Patients have used any antibiotic or anti-inflammatory drug in the last 6 months - Patients have received any periodontal treatment in the last 6 months.

Study Design


Intervention

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

Locations

Country Name City State
Turkey Kahramanmaras Sütçü Imam University Kahramanmaras

Sponsors (1)

Lead Sponsor Collaborator
Kahramanmaras Sutcu Imam University

Country where clinical trial is conducted

Turkey, 

References & Publications (6)

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. — View 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. — View Citation

Hajishengallis G. Periodontitis: from microbial immune subversion to systemic inflammation. Nat Rev Immunol. 2015 Jan;15(1):30-44. doi: 10.1038/nri3785. — View 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. — View 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. — View 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Changes in Delta Neutrophil Index values of periodontal treatment in patients with periodontitis. We expect a decrease in the Delta Neutrophil Index values after non-surgical periodontal treatment. 12 weeks
Secondary 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. 12 weeks
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