NCT05666622

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2020

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2021

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2022

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

December 9, 2022

Completed
19 days until next milestone

First Posted

Study publicly available on registry

December 28, 2022

Completed
Last Updated

January 12, 2024

Status Verified

January 1, 2024

Enrollment Period

9 months

First QC Date

December 9, 2022

Last Update Submit

January 11, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Neutrophil-lymphocyte ratio (NLR) values after non-surgical periodontal treatment.

    12 weeks

Study Arms (1)

Kahramanmaraş Sütçü İmam University

OTHER

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

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

Interventions

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

Kahramanmaraş Sütçü İmam University

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients diagnosed with periodontitis
  • Patients have more than 20 teeth in the mouth
  • Minimum age 18
  • Maximum age 65

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kahramanmaraş Sütçü İmam University

Kahramanmaraş, Turkey (Türkiye)

Location

Related Publications (7)

  • 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.

    PMID: 26252399BACKGROUND
  • Hajishengallis G. Periodontitis: from microbial immune subversion to systemic inflammation. Nat Rev Immunol. 2015 Jan;15(1):30-44. doi: 10.1038/nri3785.

    PMID: 25534621BACKGROUND
  • 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.

    PMID: 33510490BACKGROUND
  • 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.

    PMID: 31543614BACKGROUND
  • 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.

    PMID: 35060836BACKGROUND
  • 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.

    PMID: 23482854BACKGROUND
  • Ozdemir EC, Bozkurt E, Yazar FM, Bozan MB. Can delta neutrophil index values predict the success of periodontal treatment in patients with periodontitis? Clin Oral Investig. 2024 Jan 9;28(1):82. doi: 10.1007/s00784-023-05478-1.

MeSH Terms

Conditions

Periodontitis

Condition Hierarchy (Ancestors)

Periodontal DiseasesMouth DiseasesStomatognathic Diseases

Study Officials

  • Eda Çetin Özdemir, Dr.

    Kahramanmaras Sutcu Imam University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistant professor

Study Record Dates

First Submitted

December 9, 2022

First Posted

December 28, 2022

Study Start

October 1, 2020

Primary Completion

July 1, 2021

Study Completion

January 1, 2022

Last Updated

January 12, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will not share

Locations