PeriodontitisNCT06523205
Relationships Between Tenascin C, Smoking and Periodontal Status
An observational study of Periodontitis and Smoking, run by Necmettin Erbakan University.
Trial summary
The goal of this observational study is to determine if there is a relationship between different periodontal conditions (gingival healthy, stage 2 grade B, stage 2 grade C, stage 3 grade B, stage 3 grade C) and the levels of tenascin C, IL-1 beta, IL-4, and IL-6 in saliva samples from smokers and non-smokers. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Periodontitis, Smoking, Periodontal Diseases
- What is being tested?
- Clinical Measurements and Saliva Sample Collection
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2024to 15 Sep 2024
- Phase
- Observational
- 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
Study population: This study is planned to be conducted with 100 individuals aged between 18 and 65 who apply to the Department of Periodontology, Faculty of Dentistry, Necmettin Erbakan University, for various reasons. The eligibility of individuals to be included will be evaluated by Assistant Professor Dr. Osman BABAYIGIT at the Periodontology Clinic of NEU Faculty of Dentistry.
Who may be able to join
- The periodontitis groups (Non-smoking and smoking) in the study will include systemically healthy patients who are clinically diagnosed with Stage II and III, generalized, Grade B, C periodontitis based on the consensus report of the 2017 World Workshop on Classification of Periodontal and Peri-Implant Diseases and Conditions.
- Agreeing to participate in the study
Who cannot join
- use of oral contraceptive drugs
- use of antibiotics, immunosuppressants, or drug therapies in the last 6 months before the study;
- history of excessive alcohol use;
- pregnancy or breastfeeding status;
- periodontal treatment during the last 6 months before the study.
- Not agreeing to participate in the study
- Not meeting the inclusion criteria
About this study
Official title: Evaluation of the Relationships Between Salivary Tenascin C ,IL-4, IL-6, and IL-1β Levels, Smoking and Periodontal Status
The goal of this observational study is to determine if there is a relationship between different periodontal conditions (gingival healthy, stage 2 grade B, stage 2 grade C, stage 3 grade B, stage 3 grade C) and the levels of tenascin C, IL-1 beta, IL-4, and IL-6 in saliva samples from smokers and non-smokers. The main questions it aims to answer are:
Is there a difference in the levels of tenascin C, IL-1 beta, IL-4, and IL-6 between smokers and non-smokers with different periodontal conditions? Do these biomarkers correlate with the severity and grade of periodontal disease?
Read more
Researchers will compare the saliva samples from smokers and non-smokers across the different periodontal conditions to see if there are significant differences in the biomarker levels. Participants will:
Provide saliva samples. Be categorized based on their smoking status and periodontal condition.
- Conditions
- Periodontitis, Smoking, Periodontal Diseases
- Being tested
- Clinical Measurements and Saliva Sample Collection
- Keywords
- periodontitis, cytokines, saliva
- Medical subject headings
- Periodontitis, Smoking, Periodontal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinical Measurements and Saliva Sample CollectionDiagnostic test
Saliva samples will be collected from all patients. Clinical parameters will also be recorded. Plaque index (PI) and gingival index (GI) will be recorded at four sites per tooth. Full-mouth probing depth (PD) and clinical attachment level (CAL) will be detailed per tooth at six sites, and the percentage of bleeding areas will be recorded as present or absent within 20 seconds after probing using a binary scoring system. A calibrated periodontologist will record all clinical parameters using manual probing.
Following sampling, saliva samples will be stored at -80°C until analysis. Concentrations of Tenascin-C, IL-4, IL-6, and IL-1beta will be analyzed by specific enzyme-linked immunosorbent assay (ELISA) kits in saliva samples.
| Study group | Role | What they receive |
|---|---|---|
| non-smoking - periodontally healthy | participants who reported never smoking and periodontal healthy. Receives: Diagnostic Test: Clinical Measurements and Saliva Sample Collection | |
| smoking - periodontally healthy | participants who reported smoking >10 cigarettes per day and periodontal healthy. Receives: Diagnostic Test: Clinical Measurements and Saliva Sample Collection | |
| non-smoking - periodontitis | participants who reported never smoking, with clinical attachment loss ≥3 mm in >30% of sites, with probing depth ≥5 mm in at least six teeth, and with radiographic bone loss extending to or beyond the middle third of the root in the coronal third will be included. Receives: Diagnostic Test: Clinical Measurements and Saliva Sample Collection | |
| smoking - periodontitis | participants who reported smoking >10 cigarettes per day for >5 years with clinical attachment loss ≥3 mm in >30% of sites, with probing depth ≥5 mm in at least six teeth, and with radiographic bone loss extending to or beyond the middle third of the root in the coronal third will be included. Receives: Diagnostic Test: Clinical Measurements and Saliva Sample Collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
1.Periodontal clinical parameters (plaque index (PI) and gingival index (GI))
The measurements will be performed using a Williams periodontal probe (Hu-Friedy, Chicago, IL, USA) and will include plaque index (PI) and gingival index (GI) at six sites per tooth (mesio-buccal, buccal, disto-buccal, mesio-lingual, lingual and disto-lingual) on each tooth.
Gingival Index (GI) Unit: Numerical score Plaque Index (PI) Unit: Numerical score
Measured: baseline
Periodontal clinical parameters (percentage bleeding on probing (BOP))
The measurements will be performed using a Williams periodontal probe (Hu-Friedy, Chicago, IL, USA) and will include percentage bleeding on probing (BOP) at six sites per tooth (mesio-buccal, buccal, disto-buccal, mesio-lingual, lingual and disto-lingual) on each tooth.
Percentage Bleeding on Probing (BOP) Unit: Percentage (%)
Measured: baseline
Periodontal clinical parameters (Clinical Attachment Level (CAL) and Probing Pocket Depth (PPD))
The measurements will be performed using a Williams periodontal probe (Hu-Friedy, Chicago, IL, USA) and will include probing pocket depth (PPD) and clinical attachment level (CAL) at six sites per tooth (mesio-buccal, buccal, disto-buccal, mesio-lingual, lingual and disto-lingual) on each tooth.
Clinical Attachment Level (CAL) Unit: Millimeters (mm) Probing Pocket Depth (PPD) Unit: Millimeters (mm)
Measured: baseline
Levels of Tenascin C, IL-1β, IL-4 and IL-6 saliva samples
Levels of Tenascin C, IL-1β, IL-4 and IL-6 saliva samples (ng/L)
Unit: Picograms per milliliter (pg/mL)
Tenascin C, IL-1β, IL-4 and IL-6 levels will be assayed with commercially available kits using the enzyme-linked immunosorbent assay (ELISA) method.
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2024
- Study start1 Aug 2024 (estimated)
- Primary completion1 Sep 2024 (estimated)
- Study completion15 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PeriodontitisStudies of the same condition, open and under way.
- More trials run by Necmettin Erbakan UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Necmettin Erbakan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Osman Babayigit, Necmettin Erbakan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06523205
- Sponsor's protocol ID
- tenascincsmokeperiodontitis
- Status last verified
- Jul 2024
- First submitted
- 12 Jul 2024
- Last updated
- 26 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Relationships Between Salivary Tenascin C ,IL-4, IL-6, and IL-1β Levels, Smoking and Periodontal Status
- ClinicalTrials.gov ID
- NCT06523205
- Acronym / sponsor ID
- tenascincsmokeperiodontitis
- Conditions
- Periodontitis, Smoking, Periodontal Diseases
- Keywords
- periodontitis, cytokines, saliva
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Necmettin Erbakan UniversityUniversity, hospital or other
- Study start
- 1 Aug 2024 (estimated)
- Primary completion
- 1 Sep 2024 (estimated)
- Study completion
- 15 Sep 2024 (estimated)
- First posted
- 26 Jul 2024 (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 goal of this observational study is to determine if there is a relationship between different periodontal conditions (gingival healthy, stage 2 grade B, stage 2 grade C, stage 3 grade B, stage 3 grade C) and the levels of tenascin C, IL-1 beta, IL-4, and IL-6 in saliva samples from smokers and non-smokers. The main questions it aims to answer are:
Is there a difference in the levels of tenascin C, IL-1 beta, IL-4, and IL-6 between smokers and non-smokers with different periodontal conditions? Do these biomarkers correlate with the severity and grade of periodontal disease?
Researchers will compare the saliva samples from smokers and non-smokers across the different periodontal conditions to see if there are significant differences in the biomarker levels. Participants will:
Provide saliva samples. Be categorized based on their smoking status and periodontal condition.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| non-smoking - periodontally healthy | – | Diagnostic Test: Clinical Measurements and Saliva Sample Collectionparticipants who reported never smoking and periodontal healthy. |
| smoking - periodontally healthy | – | Diagnostic Test: Clinical Measurements and Saliva Sample Collectionparticipants who reported smoking >10 cigarettes per day and periodontal healthy. |
| non-smoking - periodontitis | – | Diagnostic Test: Clinical Measurements and Saliva Sample Collectionparticipants who reported never smoking, with clinical attachment loss ≥3 mm in >30% of sites, with probing depth ≥5 mm in at least six teeth, and with radiographic bone loss extending to or beyond the middle third of the root in the coronal third will be included. |
| smoking - periodontitis | – | Diagnostic Test: Clinical Measurements and Saliva Sample Collectionparticipants who reported smoking >10 cigarettes per day for >5 years with clinical attachment loss ≥3 mm in >30% of sites, with probing depth ≥5 mm in at least six teeth, and with radiographic bone loss extending to or beyond the middle third of the root in the coronal third will be included. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- This study is planned to be conducted with 100 individuals aged between 18 and 65 who apply to the Department of Periodontology, Faculty of Dentistry, Necmettin Erbakan University, for various reasons. The eligibility of individuals to be included will be evaluated by Assistant Professor Dr. Osman BABAYIGIT at the Periodontology Clinic of NEU Faculty of Dentistry.
Key inclusion criteria (2 listed)
- The periodontitis groups (Non-smoking and smoking) in the study will include systemically healthy patients who are clinically diagnosed with Stage II and III, generalized, Grade B, C periodontitis based on the consensus report of the 2017 World Workshop on Classification of Periodontal and Peri-Implant Diseases and Conditions.
- Agreeing to participate in the study
Key exclusion criteria (7 listed)
- use of oral contraceptive drugs
- use of antibiotics, immunosuppressants, or drug therapies in the last 6 months before the study;
- history of excessive alcohol use;
- pregnancy or breastfeeding status;
- periodontal treatment during the last 6 months before the study.
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 |
|---|---|---|
| Clinical Measurements and Saliva Sample CollectionSaliva samples will be collected from all patients. Clinical parameters will also be recorded. Plaque index (PI) and gingival index (GI) will be recorded at four sites per tooth. Full-mouth probing depth (PD) and clinical attachment level (CAL) will be detailed per tooth at six sites, and the percentage of bleeding areas will be recorded as present or absent within 20 seconds after probing using a binary scoring system. A calibrated periodontologist will record all clinical parameters using manual probing. Following sampling, saliva samples will be stored at -80°C until analysis. Concentrations of Tenascin-C, IL-4, IL-6, and IL-1beta will be analyzed by specific enzyme-linked immunosorbent assay (ELISA) kits in saliva samples. | Diagnostic test | non-smoking - periodontally healthy, non-smoking - periodontitis, smoking - periodontally healthy, smoking - periodontitis |
Primary outcome
1.Periodontal clinical parameters (plaque index (PI) and gingival index (GI))
Time frame: baseline
The measurements will be performed using a Williams periodontal probe (Hu-Friedy, Chicago, IL, USA) and will include plaque index (PI) and gingival index (GI) at six sites per tooth (mesio-buccal, buccal, disto-buccal, mesio-lingual, lingual and disto-lingual) on each tooth. Gingival Index (GI) Unit: Numerical score Plaque Index (PI) Unit: Numerical score
Periodontal clinical parameters (percentage bleeding on probing (BOP))
Time frame: baseline
The measurements will be performed using a Williams periodontal probe (Hu-Friedy, Chicago, IL, USA) and will include percentage bleeding on probing (BOP) at six sites per tooth (mesio-buccal, buccal, disto-buccal, mesio-lingual, lingual and disto-lingual) on each tooth. Percentage Bleeding on Probing (BOP) Unit: Percentage (%)
Periodontal clinical parameters (Clinical Attachment Level (CAL) and Probing Pocket Depth (PPD))
Time frame: baseline
The measurements will be performed using a Williams periodontal probe (Hu-Friedy, Chicago, IL, USA) and will include probing pocket depth (PPD) and clinical attachment level (CAL) at six sites per tooth (mesio-buccal, buccal, disto-buccal, mesio-lingual, lingual and disto-lingual) on each tooth. Clinical Attachment Level (CAL) Unit: Millimeters (mm) Probing Pocket Depth (PPD) Unit: Millimeters (mm)
Levels of Tenascin C, IL-1β, IL-4 and IL-6 saliva samples
Time frame: baseline
Levels of Tenascin C, IL-1β, IL-4 and IL-6 saliva samples (ng/L) Unit: Picograms per milliliter (pg/mL) Tenascin C, IL-1β, IL-4 and IL-6 levels will be assayed with commercially available kits using the enzyme-linked immunosorbent assay (ELISA) method.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2024.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Periodontitis and Smoking, run by Necmettin Erbakan University.
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 2 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 26 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
1.Periodontal clinical parameters (plaque index (PI) and gingival index (GI)) (time frame: baseline). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Jul 2024.