PeriodontitisNCT05417061
Serum and Saliva Sirtuin 6, Lipoxin A4, Caspase8 Levels in Correlation With Periodontal Status in Severe Periodontitis
A study testing Saliva and serum sampling in people with Periodontitis and Diagnose Disease, run by Istanbul Medipol University Hospital at 1 site in Turkey (Türkiye).
Trial summary
It has been stated that Sirtuin-6 (SIRT6) play a important role in regulation of inflammation, energy metabolism, homeostasis and apoptosis, and SIRT6 may be assosiciated with many diseases. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Periodontitis, Diagnose Disease
- What is being tested?
- Saliva and serum sampling
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 14 Oct 2021to 30 May 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
- systemically healthy
- clinical diagnosis of periodontitis
- clinical diagnosis of periodontal health
Who cannot join
- history of regular use of systemic antibiotics anti-inflammatory, or antioxidant drugs (previous 3 months)
- nonsurgical periodontal treatment (previous 6 months)
- surgical periodontal treatment (previous 12 months)
- presence of<10 teeth
- current medications affecting gingival health (calcium channel blockers, phenytoin, cyclosporine, and hormone replacement therapy)
- diabetes
Show all 11Show fewer
- diagnosis of rheumatoid arthritis
- pregnancy
- lactating
- smoking
- excessive alcohol consumption.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul Medipol University, School of Dentistry
Istanbul, Fatih, 34083
About this study
It has been stated that Sirtuin-6 (SIRT6) play a important role in regulation of inflammation, energy metabolism, homeostasis and apoptosis, and SIRT6 may be assosiciated with many diseases. The aim of this study was to evaluate saliva and serum SIRT6, Lipoxin A4 (LXA4) and Caspase-8 (CASP8) levels in correlation with periodontal clinical status in patients with periodontitis and healthy subjects
Read the detailed description
20 patients with Stage III Grade B periodontitis (P) and 20 periodontally healthy individuals (control;C) were included in this study. Clinical periodontal parameters were measured. Saliva and serum levels of SIRT6, LXA4 and CASP8 were analyzed by enzyme-linked immunosorbent assay.
- Conditions
- Periodontitis, Diagnose Disease
- Being tested
- Saliva and serum sampling
- Keywords
- inflammation resolution, periodontitis, cell apoptosis
- Medical subject headings
- Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Saliva and serum samplingOther
Saliva were collected to analyze the selected markers as unstimulated samples during the early hours of the day. The saliva was centrifuged and then transferred into Eppendorf tubes.
Venous puncture was performed after saliva collection and 10 mL of blood samples were collected by qualified staff (MFD) from each participant. Saliva and serum were then stored at -80 °C until analysis.
| Study group | Role | What they receive |
|---|---|---|
| Saliva and serum collection of patients and samples molecules analysis | Active comparator | Not described Receives: Other: Saliva and serum sampling |
| Salivary and serum SIRT6, LPXA4 and CASP8 observation | Experimental | Saliva and serum samples obtained for each patient were used for cytokine analysis. Prepared samples were analyzed for Lipoxin A4 (LXA4), Caspase 8 (CASP8) and Sirtuin-6 (SIRT6) using commercial ELISA kits
(Elabscience, Houston, Texas, USA and Bioaasay Technology Laboratory (BT-Lab), Shanghai, China, respectively) according to the manufacturer's instructions. The detection limits of ELISA kits were 0.78 - 50ng/ml for LXA4, 0.16 - 10ng/ml for CASP8 and 0.1- 40 ng/ml for SIRT6. Receives: Other: Saliva and serum sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pocket probing depth
Measurement of the depth of a sulcus or periodontal pocket determined by measuring distance from a gingival margin to the base of the sulcus or pocket with a calibrated periodontal probe.
Measured: 6 months
Clinical attachment level
Clinical attachment level (or loss, CAL) is a more accurate indicator of the periodontal support around a tooth than probing depth alone. CAL is measured from a fixed point on the tooth that does not change, the CEJ.
To calculate CAL, two measurements are needed: distance from the gingival margin to the CEJ and probing depth.
In recession: probing depth (+) gingival margin to the CEJ (add). In tissue overgrowth: probing depth (-) gingival margin to the CEJ (subtract)
Measured: 6 months
Bleeding on probing
referring to bleeding that is induced by gentle manipulation of the tissue at the depth of the gingival sulcus, or interface between the gingiva and a tooth.
Measured: 6 months
Secondary outcomes (1)
Saliva and serum samples processing and analyses
Saliva and serum samples obtained for each patient were used for cytokine analysis. Prepared samples were analyzed for Lipoxin A4 (LXA4), Caspase 8 (CASP8) and Sirtuin-6 (SIRT6) using commercial ELISA kits
(Elabscience, Houston, Texas, USA and Bioaasay Technology Laboratory (BT-Lab), Shanghai, China, respectively) according to the manufacturer's instructions.
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2022
- Study start14 Oct 2021
- Primary completion21 Apr 2022
- Study completion30 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Model description
- Saliva and serum of periodontitis patients collected for analyzing SIRT6, LPXA4, CASP8
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Medipol University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nur Balci, DDs, PhD, Istanbul Medipol University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05417061
- Sponsor's protocol ID
- 138
- Status last verified
- Jun 2022
- First submitted
- 9 Jun 2022
- Last updated
- 23 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Cekici A, Sahinkaya S, Donmez MF, Turkmen E, Balci N, Toygar H. Sirtuin6 and Lipoxin A4 levels are decreased in severe periodontitis. Clin Oral Investig. 2023 Dec;27(12):7407-7415. doi: 10.1007/s00784-023-05330-6. Epub 2023 Oct 18.
PubMed 37851128
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Serum and Saliva Sirtuin 6, Lipoxin A4, Caspase8 Levels in Correlation With Periodontal Status in Severe Periodontitis
- ClinicalTrials.gov ID
- NCT05417061
- Acronym / sponsor ID
- 138
- Conditions
- Periodontitis, Diagnose Disease
- Keywords
- inflammation resolution, periodontitis, cell apoptosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Istanbul Medipol University HospitalUniversity, hospital or other
- Study start
- 14 Oct 2021 (actual)
- Primary completion
- 21 Apr 2022 (actual)
- Study completion
- 30 May 2022 (actual)
- First posted
- 14 Jun 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.
It has been stated that Sirtuin-6 (SIRT6) play a important role in regulation of inflammation, energy metabolism, homeostasis and apoptosis, and SIRT6 may be assosiciated with many diseases. The aim of this study was to evaluate saliva and serum SIRT6, Lipoxin A4 (LXA4) and Caspase-8 (CASP8) levels in correlation with periodontal clinical status in patients with periodontitis and healthy subjects
Detailed description
20 patients with Stage III Grade B periodontitis (P) and 20 periodontally healthy individuals (control;C) were included in this study. Clinical periodontal parameters were measured. Saliva and serum levels of SIRT6, LXA4 and CASP8 were analyzed by enzyme-linked immunosorbent assay.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Saliva and serum of periodontitis patients collected for analyzing SIRT6, LPXA4, CASP8
| Arm | Type | Receives |
|---|---|---|
| Saliva and serum collection of patients and samples molecules analysis | Active comparator | Other: Saliva and serum sampling |
| Salivary and serum SIRT6, LPXA4 and CASP8 observation | Experimental | Other: Saliva and serum samplingSaliva and serum samples obtained for each patient were used for cytokine analysis. Prepared samples were analyzed for Lipoxin A4 (LXA4), Caspase 8 (CASP8) and Sirtuin-6 (SIRT6) using commercial ELISA kits (Elabscience, Houston, Texas, USA and Bioaasay Technology Laboratory (BT-Lab), Shanghai, China, respectively) according to the manufacturer's instructions. The detection limits of ELISA kits were 0.78 - 50ng/ml for LXA4, 0.16 - 10ng/ml for CASP8 and 0.1- 40 ng/ml for SIRT6. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- systemically healthy
- clinical diagnosis of periodontitis
- clinical diagnosis of periodontal health
Key exclusion criteria (11 listed)
- history of regular use of systemic antibiotics anti-inflammatory, or antioxidant drugs (previous 3 months)
- nonsurgical periodontal treatment (previous 6 months)
- surgical periodontal treatment (previous 12 months)
- presence of<10 teeth
- current medications affecting gingival health (calcium channel blockers, phenytoin, cyclosporine, and hormone replacement therapy)
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 |
|---|---|---|
| Saliva and serum samplingSaliva were collected to analyze the selected markers as unstimulated samples during the early hours of the day. The saliva was centrifuged and then transferred into Eppendorf tubes. Venous puncture was performed after saliva collection and 10 mL of blood samples were collected by qualified staff (MFD) from each participant. Saliva and serum were then stored at -80 °C until analysis. | Other | Saliva and serum collection of patients and samples molecules analysis, Salivary and serum SIRT6, LPXA4 and CASP8 observation |
Primary outcome
Pocket probing depth
Time frame: 6 months
Measurement of the depth of a sulcus or periodontal pocket determined by measuring distance from a gingival margin to the base of the sulcus or pocket with a calibrated periodontal probe.
Clinical attachment level
Time frame: 6 months
Clinical attachment level (or loss, CAL) is a more accurate indicator of the periodontal support around a tooth than probing depth alone. CAL is measured from a fixed point on the tooth that does not change, the CEJ. To calculate CAL, two measurements are needed: distance from the gingival margin to the CEJ and probing depth. In recession: probing depth (+) gingival margin to the CEJ (add). In tissue overgrowth: probing depth (-) gingival margin to the CEJ (subtract)
Bleeding on probing
Time frame: 6 months
referring to bleeding that is induced by gentle manipulation of the tissue at the depth of the gingival sulcus, or interface between the gingiva and a tooth.
1 secondary outcome
Saliva and serum samples processing and analyses
Time frame: 2 months
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 23 Oct 2023.
- Derived from this study: PubMed 37851128Cekici A, Sahinkaya S, Donmez MF, Turkmen E, Balci N, Toygar H. Sirtuin6 and Lipoxin A4 levels are decreased in severe periodontitis. Clin Oral Investig. 2023 Dec;27(12):7407-7415. doi: 10.1007/s00784-023-05330-6. Epub 2023 Oct 18.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Saliva and serum sampling in people with Periodontitis and Diagnose Disease, run by Istanbul Medipol University Hospital 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 3 inclusion and 11 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 23 Oct 2023. 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?
Pocket probing depth (time frame: 6 months). The study lists 3 primary outcomes in all. 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 NCT05417061, which also lists 1 linked publication.
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 23 Oct 2023.