PeriodontitisNCT06245265
The Effect of Non-Surgical Periodontal Therapy on Rheumatoid Arthritis
A study testing ELISA (Enzyme-Linked ImmunoSorbent Assay) in people with Periodontitis and Rheumatoid Arthritis, run by Biruni University at 1 site in Turkey (Türkiye).
Trial summary
Periodontitis is a common chronic inflammatory disease characterised by the destruction of the soft and hard tissues supporting the tooth, including alveolar bone, periodontal ligament and cementum. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Periodontitis, Rheumatoid Arthritis
- What is being tested?
- ELISA (Enzyme-Linked ImmunoSorbent Assay)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2024to 1 Oct 2024
- 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
- To be between the ages of 18-65,
- Having at least 8 teeth excluding wisdom teeth,
- No periodontal treatment in the last 3 months,
- Not having used antibiotics in the last 3 months,
- Not being pregnant or breastfeeding,
- The individuals to be included in the control group should not have any systemic disease that may change the periodontal status, and the individuals to be included in the experimental group should not have any systemic disease that may affect periodontal health except RA.
Who cannot join
- Under 18 years of age and over 65 years of age,
- Having less than 8 teeth,
- Having undergone periodontal treatment in the last 3 months,
- Having used antibiotics in the last 3 months,
- Being pregnant or breastfeeding,
- Individuals to be included in the control group should have any systemic disease that may change the periodontal status, and individuals to be included in the test group should have any systemic disease that may affect periodontal health except RA.
- Abnormal body mass index (more than 29.9 kg/m2).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Effect of Non-Surgical Periodontal Therapy on Serum and Salivary Biomarker Levels in Individuals With Rheumatoid Arthritis
Periodontitis is a common chronic inflammatory disease characterised by the destruction of the soft and hard tissues supporting the tooth, including alveolar bone, periodontal ligament and cementum. Periodontitis has been associated with different host characteristics such as diabetes or neutrophil disorders and environmental factors such as smoking, alcohol consumption and stress. On the other hand, periodontal bacterial infection triggers a systemic immune response that is associated with an increased risk of different disorders such as bacterial pneumonia, cardiovascular disease and autoimmune diseases. Rheumatoid arthritis (RA) is a severe chronic autoimmune disease of unknown etiology, characterised by symmetrical, erosive synovitis of the joints, sometimes with multisystem organ involvement, joint destruction and excessive bone loss. Although the etiology of RA is unknown, it is thought to occur in individuals with genetic predisposition as a result of exposure to various environmental factors. RA and periodontitis are chronic destructive inflammatory diseases with common genetic and environmental risk factors, pathogenesis mechanisms and complex multifactorial pathological processes. Several studies suggest that periodontitis, a common inflammatory disease of the periodontium surrounding the teeth and triggered by bacteria in the mouth, is associated with RA and may initiate and worsen inflammation in RA. Non-surgical periodontal treatment (COPT), which is considered the gold standard in the treatment of periodontitis with hand instruments and ultrasonic instruments, has been shown to provide significant improvements in the clinical outcomes of periodontitis patients with RA. COPT is performed to stop the progression of periodontal diseases. Considering the studies supporting the bidirectional relationship between periodontitis and RA, it is thought that COPT may affect the clinical and biochemical values of RA. Based on these points, the aim of our study was to investigate the relationship between serum and salivary ANGPTL-4, MMP-13, TNF-α and IL-6 levels and periodontal disease in individuals with RA and to evaluate the effects of COPT on RA disease severity in vivo.
- Conditions
- Periodontitis, Rheumatoid Arthritis
- Being tested
- ELISA (Enzyme-Linked ImmunoSorbent Assay)
- Keywords
- Periodontititis, Rheumatoid arthritis, Cytokine
- Medical subject headings
- Periodontitis, Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ELISA (Enzyme-Linked ImmunoSorbent Assay)Other
In this study, 15 periodontitis patients with RA, 15 healthy individuals with RA, 15 systemic healthy periodontitis patients and 15 systemic periodontally healthy individuals will be included. ANGPTL-4 biomarker and other biomarkers (MMP-13, TNF-α, IL-6) that have not been previously analysed in the serum and saliva of both RA and periodontitis patients will be evaluated before and 3 months after COPT. Clinical parameters (Plaque index, probing depth, gingival recession, clinical attachment level, bleeding on probing), biochemical evaluations of serum, saliva and gingival samples will be performed and correlated with clinical parameters at baseline and 3 months after COPT in all individuals with periodontitis included in the study.
| Study group | Role | What they receive |
|---|---|---|
| Clinical Healthy | Experimental | Clinical measurements (Plaque index, probing depth, gingival recession, clinical attachment level, bleeding on probing) salivary sample and serum will be taken from all individuals at the beginning of the study. ANGPTL-4 levels will be examined to evaluate before and after treatment in periodontal health and periodontitis. A pre-treatment saliva sample and serum will be collected from the clinically healthy group. Receives: Other: ELISA (Enzyme-Linked ImmunoSorbent Assay) |
| Periodontitis | Experimental | Non-surgical periodontal treatment will be applied to individuals with periodontitis, clinical measurements, saliva collection and serum will be repeated 12 weeks after the treatment. ANGPTL-4 analysis will be performed by ELISA in saliva and serum of individuals. ANGPTL-4 levels will be examined to evaluate before and after treatment in periodontal health and periodontitis. Clinical measurements (Plaque index, probing depth, gingival recession, clinical attachment level, bleeding on probing) and salivary sample will be taken from all individuals at the beginning of the study. Receives: Other: ELISA (Enzyme-Linked ImmunoSorbent Assay) |
| Periodontitis with rheumatoid arthritis | Experimental | Non-surgical periodontal treatment will be applied to individuals with periodontitis, clinical measurements, saliva collection and serum will be repeated 12 weeks after the treatment. ANGPTL-4 analysis will be performed by ELISA in saliva and serum of individuals. ANGPTL-4 levels will be examined to evaluate before and after treatment in periodontitis with rheumatoid arthritis. Clinical measurements (Plaque index, probing depth, gingival recession, clinical attachment level, bleeding on probing) and salivary sample will be taken from all individuals at the beginning of the study. Receives: Other: ELISA (Enzyme-Linked ImmunoSorbent Assay) |
| Healthy individuals with RA | Experimental | Clinical measurements (Plaque index, probing depth, gingival recession, clinical attachment level, bleeding on probing) salivary sample and serum fluid will be taken from all individuals at the beginning of the study. ANGPTL-4 levels will be examined to evaluate before and after treatment in periodontal health and periodontitis. A pre-treatment saliva sample and serum will be collected from the healthy individuals with RA group. Receives: Other: ELISA (Enzyme-Linked ImmunoSorbent Assay) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Examination of ANGPTL-4 levels of periodontal disease and rheumatoid arthritis
Examination of ANGPTL-4 levels, which are stated to be associated with periodontal disease, in serum and saliva samples obtained from individuals with periodontitis and periodontitis individuals with RA.
Measured: up to 1 year
Secondary outcomes (1)
Evaluation of the effect of non-surgical periodontal treatment on changes in ANGPTL-4 level.
Evaluation of the effect of non-surgical periodontal treatment on changes in ANGPTL-4 level.
Measured: up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2024
- Study start1 Jan 2024
- Primary completion1 Jun 2024
- Study completion1 Oct 2024
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 Biruni 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biruni University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Burcu KARADUMAN, Biruni University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06245265
- Sponsor's protocol ID
- 2015-KAEK-80-23-02
- Status last verified
- Feb 2024
- First submitted
- 26 Jan 2024
- Last updated
- 25 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effect of Non-Surgical Periodontal Therapy on Serum and Salivary Biomarker Levels in Individuals With Rheumatoid Arthritis
- ClinicalTrials.gov ID
- NCT06245265
- Acronym / sponsor ID
- 2015-KAEK-80-23-02
- Conditions
- Periodontitis, Rheumatoid Arthritis
- Keywords
- Periodontititis, Rheumatoid arthritis, Cytokine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Biruni UniversityUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 1 Jun 2024 (actual)
- Study completion
- 1 Oct 2024 (actual)
- First posted
- 7 Feb 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.
Periodontitis is a common chronic inflammatory disease characterised by the destruction of the soft and hard tissues supporting the tooth, including alveolar bone, periodontal ligament and cementum. Periodontitis has been associated with different host characteristics such as diabetes or neutrophil disorders and environmental factors such as smoking, alcohol consumption and stress. On the other hand, periodontal bacterial infection triggers a systemic immune response that is associated with an increased risk of different disorders such as bacterial pneumonia, cardiovascular disease and autoimmune diseases. Rheumatoid arthritis (RA) is a severe chronic autoimmune disease of unknown etiology, characterised by symmetrical, erosive synovitis of the joints, sometimes with multisystem organ involvement, joint destruction and excessive bone loss. Although the etiology of RA is unknown, it is thought to occur in individuals with genetic predisposition as a result of exposure to various environmental factors. RA and periodontitis are chronic destructive inflammatory diseases with common genetic and environmental risk factors, pathogenesis mechanisms and complex multifactorial pathological processes. Several studies suggest that periodontitis, a common inflammatory disease of the periodontium surrounding the teeth and triggered by bacteria in the mouth, is associated with RA and may initiate and worsen inflammation in RA. Non-surgical periodontal treatment (COPT), which is considered the gold standard in the treatment of periodontitis with hand instruments and ultrasonic instruments, has been shown to provide significant improvements in the clinical outcomes of periodontitis patients with RA. COPT is performed to stop the progression of periodontal diseases. Considering the studies supporting the bidirectional relationship between periodontitis and RA, it is thought that COPT may affect the clinical and biochemical values of RA. Based on these points, the aim of our study was to investigate the relationship between serum and salivary ANGPTL-4, MMP-13, TNF-α and IL-6 levels and periodontal disease in individuals with RA and to evaluate the effects of COPT on RA disease severity in vivo.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Clinical Healthy | Experimental | Other: ELISA (Enzyme-Linked ImmunoSorbent Assay)Clinical measurements (Plaque index, probing depth, gingival recession, clinical attachment level, bleeding on probing) salivary sample and serum will be taken from all individuals at the beginning of the study. ANGPTL-4 levels will be examined to evaluate before and after treatment in periodontal health and periodontitis. A pre-treatment saliva sample and serum will be collected from the clinically healthy group. |
| Periodontitis | Experimental | Other: ELISA (Enzyme-Linked ImmunoSorbent Assay)Non-surgical periodontal treatment will be applied to individuals with periodontitis, clinical measurements, saliva collection and serum will be repeated 12 weeks after the treatment. ANGPTL-4 analysis will be performed by ELISA in saliva and serum of individuals. ANGPTL-4 levels will be examined to evaluate before and after treatment in periodontal health and periodontitis. Clinical measurements (Plaque index, probing depth, gingival recession, clinical attachment level, bleeding on probing) and salivary sample will be taken from all individuals at the beginning of the study. |
| Periodontitis with rheumatoid arthritis | Experimental | Other: ELISA (Enzyme-Linked ImmunoSorbent Assay)Non-surgical periodontal treatment will be applied to individuals with periodontitis, clinical measurements, saliva collection and serum will be repeated 12 weeks after the treatment. ANGPTL-4 analysis will be performed by ELISA in saliva and serum of individuals. ANGPTL-4 levels will be examined to evaluate before and after treatment in periodontitis with rheumatoid arthritis. Clinical measurements (Plaque index, probing depth, gingival recession, clinical attachment level, bleeding on probing) and salivary sample will be taken from all individuals at the beginning of the study. |
| Healthy individuals with RA | Experimental | Other: ELISA (Enzyme-Linked ImmunoSorbent Assay)Clinical measurements (Plaque index, probing depth, gingival recession, clinical attachment level, bleeding on probing) salivary sample and serum fluid will be taken from all individuals at the beginning of the study. ANGPTL-4 levels will be examined to evaluate before and after treatment in periodontal health and periodontitis. A pre-treatment saliva sample and serum will be collected from the healthy individuals with RA group. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- To be between the ages of 18-65,
- Having at least 8 teeth excluding wisdom teeth,
- No periodontal treatment in the last 3 months,
- Not having used antibiotics in the last 3 months,
- Not being pregnant or breastfeeding,
Key exclusion criteria (7 listed)
- Under 18 years of age and over 65 years of age,
- Having less than 8 teeth,
- Having undergone periodontal treatment in the last 3 months,
- Having used antibiotics in the last 3 months,
- Being pregnant or breastfeeding,
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 |
|---|---|---|
| ELISA (Enzyme-Linked ImmunoSorbent Assay)In this study, 15 periodontitis patients with RA, 15 healthy individuals with RA, 15 systemic healthy periodontitis patients and 15 systemic periodontally healthy individuals will be included. ANGPTL-4 biomarker and other biomarkers (MMP-13, TNF-α, IL-6) that have not been previously analysed in the serum and saliva of both RA and periodontitis patients will be evaluated before and 3 months after COPT. Clinical parameters (Plaque index, probing depth, gingival recession, clinical attachment level, bleeding on probing), biochemical evaluations of serum, saliva and gingival samples will be performed and correlated with clinical parameters at baseline and 3 months after COPT in all individuals with periodontitis included in the study. | Other | Clinical Healthy, Healthy individuals with RA, Periodontitis, Periodontitis with rheumatoid arthritis |
Primary outcome
Examination of ANGPTL-4 levels of periodontal disease and rheumatoid arthritis
Time frame: up to 1 year
Examination of ANGPTL-4 levels, which are stated to be associated with periodontal disease, in serum and saliva samples obtained from individuals with periodontitis and periodontitis individuals with RA.
1 secondary outcome
Evaluation of the effect of non-surgical periodontal treatment on changes in ANGPTL-4 level.
Time frame: up to 1 year
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 25 Jun 2025.
- 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 ELISA (Enzyme-Linked ImmunoSorbent Assay) in people with Periodontitis and Rheumatoid Arthritis, run by Biruni 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 6 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: finished, as of the sponsor's last update on 25 Jun 2025. 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?
Examination of ANGPTL-4 levels of periodontal disease and rheumatoid arthritis (time frame: up to 1 year). 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 25 Jun 2025.