PeriodontitisNCT05666622
DNI Values After Periodontal Treatment
A study testing Only routine non-surgical periodontal treatment was applied to the patients. in people with Periodontitis and Periodontal Inflammation, run by Kahramanmaras Sutcu Imam University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Periodontitis, Periodontal Inflammation, Inflammatory Response
- What is being tested?
- Only routine non-surgical periodontal treatment was applied to the patients.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Oct 2020to 1 Jan 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients diagnosed with periodontitis
- Patients have more than 20 teeth in the mouth
- Minimum age 18
- Maximum age 65
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Kahramanmaraş Sütçü İmam University
Kahramanmaraş
About this study
Official title: Can Delta Neutrophil Index Values Predict the Success of Periodontal Treatment in Patients With Periodontitis?
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.
Read the 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.
- Being tested
- Only routine non-surgical periodontal treatment was applied to the patients.
- Medical subject headings
- Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Only routine non-surgical periodontal treatment was applied to the patients.Other
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
| Study group | Role | What they receive |
|---|---|---|
| Kahramanmaraş Sütçü İmam University | Other | Only routine non-surgical periodontal treatment was applied to the patients. Receives: Other: Only routine non-surgical periodontal treatment was applied to the patients. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 weeks
Secondary outcomes (1)
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.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2022
- Study start1 Oct 2020
- Primary completion1 Jul 2021
- Study completion1 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for PeriodontitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kahramanmaras Sutcu Imam University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eda Cetin Ozdemir, Kahramanmaras Sutcu Imam University
- Investigators
- Eda Çetin Özdemir, Dr., Principal investigator, Kahramanmaras Sutcu Imam University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05666622
- Sponsor's protocol ID
- 2020/18-05
- Status last verified
- Jan 2024
- First submitted
- 9 Dec 2022
- Last updated
- 12 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 26252399Hajishengallis G. Periodontitis: from microbial immune subversion to systemic inflammation. Nat Rev Immunol. 2015 Jan;15(1):30-44. doi: 10.1038/nri3785.
PubMed 25534621Hajishengallis 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.
PubMed 33510490Acharya 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.
PubMed 31543614Valiyaveetil 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.
PubMed 35060836Yoon 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.
PubMed 23482854Ozdemir 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.
PubMed 38195732
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can Delta Neutrophil Index Values Predict the Success of Periodontal Treatment in Patients With Periodontitis?
- ClinicalTrials.gov ID
- NCT05666622
- Acronym / sponsor ID
- 2020/18-05
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Kahramanmaras Sutcu Imam UniversityUniversity, hospital or other
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 1 Jul 2021 (actual)
- Study completion
- 1 Jan 2022 (actual)
- First posted
- 28 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Kahramanmaraş Sütçü İmam University | Other | Other: Only routine non-surgical periodontal treatment was applied to the patients.Only routine non-surgical periodontal treatment was applied to the patients. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients diagnosed with periodontitis
- Patients have more than 20 teeth in the mouth
- Minimum age 18
- Maximum age 65
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Other | Kahramanmaraş Sütçü İmam University |
Primary outcome
Changes in Delta Neutrophil Index values of periodontal treatment in patients with periodontitis.
Time frame: 12 weeks
We expect a decrease in the Delta Neutrophil Index values after non-surgical periodontal treatment.
1 secondary outcome
Neutrophil-lymphocyte ratio (NLR) values after non-surgical periodontal treatment.
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2024.
- Background: PubMed 26252399Roberts 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.
- Background: PubMed 25534621Hajishengallis G. Periodontitis: from microbial immune subversion to systemic inflammation. Nat Rev Immunol. 2015 Jan;15(1):30-44. doi: 10.1038/nri3785.
- Background: PubMed 33510490Hajishengallis 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.
- Background: PubMed 31543614Acharya 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.
- Background: PubMed 35060836Valiyaveetil 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.
- Background: PubMed 23482854Yoon 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.
- Derived from this study: PubMed 38195732Ozdemir 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eda Çetin Özdemir, Dr. principal investigator
Kahramanmaras Sutcu Imam University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Only routine non-surgical periodontal treatment was applied to the patients. in people with Periodontitis and Periodontal Inflammation, run by Kahramanmaras Sutcu Imam University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in Delta Neutrophil Index values of periodontal treatment in patients with periodontitis. (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05666622, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2024.