Peridontal DiseaseNCT06818045
Nonsurgical Periodontal Treatment Combined With Anti-TNF-α in Patients With Rheumatoid Arthritis and Periodontitis
A study testing Non Surgical Periodontal Treatment, Periodontal measurements will be performed and biochemical measurements in people with Peridontal Disease and Rheumatic Arthritis, run by Hatice Yemenoğlu at 1 site in Turkey (Türkiye).
Trial summary
Periodontitis is a multifactorial disease of the periodontium that can lead to destruction of the alveolar bone and supporting connective tissue and subsequent tooth loss. Recent studies have shown that periodontitis is associated with age, smoking habits, genetic predisposition, socioeconomic status, and various… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Peridontal Disease, Rheumatic Arthritis
- What is being tested?
- Non Surgical Periodontal Treatment, Periodontal measurements will be performed and biochemical measurements
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2024to 18 Apr 2025
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Being between the ages of 18-65,
- Having a confirmed diagnosis of Rheumatoid Arthritis (RA),
- Having a diagnosis of Stage III-IV periodontitis,
- Having at least 20 teeth,
Who cannot join
- Having used antibiotics for the 3 months before the study,
- Being pregnant and lactating,
- Having received periodontal treatment in the last 6 months,
- Being diabetic.
- Smoking.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Recep Tayyip Erdoğan University Faculty of Dentistry
Rize, 53020
About this study
Official title: Investigation of the Effect of Nonsurgical Periodontal Treatment Applied Together With Anti-TNF-α on Alveolar Bone Loss and Oxidative Stress in Patients With Rheumatoid Arthritis and Periodontitis
Periodontitis is a multifactorial disease of the periodontium that can lead to destruction of the alveolar bone and supporting connective tissue and subsequent tooth loss. Recent studies have shown that periodontitis is associated with age, smoking habits, genetic predisposition, socioeconomic status, and various systemic diseases such as diabetes mellitus, atherosclerosis, obesity, osteoporosis, and rheumatoid arthritis (RA). RA is a chronic, systemic inflammatory disease of unknown etiology that primarily affects the joints. Periodontitis and RA have similar clinical and pathogenic features. Clinically, both diseases are characterized by local destruction of hard and soft tissues. Their pathogenesis involves the release of cytokines and matrix metalloproteinases (MMPs) from inflammatory cells. Expression of proinflammatory cytokines such as tumor necrosis factor-alpha (TNF-α) leads to the release of high levels of inflammatory mediators that cause bone destruction and the spread of inflammation. TNF-α is the main regulatory cytokine in both RA and periodontitis. TNF-α inhibitors (anti-TNF-α) reduce the number of inflammatory cells, osteoclast formation and bone loss. In addition, many immunological processes have been identified that are similar to both diseases. Autoreactive T cells, natural killer cells, heat shock proteins, autoantibodies and genetic factors are reported to play an important role in the inflammatory pathway of RA and periodontitis.
Recently, TNF-α blocking agents (anti-TNF-α) have been developed and used for the treatment of RA. Animal and human studies have suggested that anti-TNF-α treatment may reduce the severity of periodontitis.
The aim of this study was to investigate the effect of nonsurgical periodontal treatment combined with anti-TNF-α on alveolar bone loss and oxidative stress in individuals with RA and periodontitis.
- Conditions
- Peridontal Disease, Rheumatic Arthritis
- Being tested
- Non Surgical Periodontal Treatment, Periodontal measurements will be performed, biochemical measurements, No medication will be administered to patients.
- Keywords
- rheumatoid arthritis, periodontal disease, inflammation
- Medical subject headings
- Rheumatic Fever, Arthritis, Rheumatoid, Periodontal Diseases, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non Surgical Periodontal TreatmentProcedure or surgery
This procedure will be applied to all patients. All patients received nonsurgical periodontal treatment. Scaling root planing and subgingival debridement were performed.
Periodontal measurements will be performedOther
Periodontal measurements will be performed on all patients (plaque index, gingival index, bleeding on probing, periodontal pocket depth, clinical attachment loss).
biochemical measurementsOther
Serum and gingival crevicular fluid (GCF) samples will be collected from patients for biochemical evaluations.
No medication will be administered to patients.Other
No medication will be administered to patients.
| Study group | Role | What they receive |
|---|---|---|
| control | Experimental | Not described Receives: Procedure: Non Surgical Periodontal Treatment; Other: Periodontal measurements will be performed; Other: biochemical measurements; Other: No medication will be administered to patients. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Periodontal pocket depth
The distance between the pocket base and the gingival margin is measured
Measured: baseline, 3rd month after non-surgical periodontal therapy, 6th month after non-surgical periodontal therapy
clinical attachment loss
The distance between the pocket base and the cementoenamel junction is measured
Measured: baseline, 3rd month after non-surgical periodontal therapy, 6th month after non-surgical periodontal therapy
Secondary outcomes (5)
serum and GCF receptor activator nuclear kappa B ligand (RANKL) level
RANKL levels in serum and GCF will be measured with biochemical kits.
Measured: baseline, after non-surgical periodontal therapy at 3 months, after non-surgical periodontal therapy at 6 months,
serum and GCF osteoprotegrin (OPG) level
OPG levels in serum and GCF will be measured with biochemical kits.
Measured: baseline, after non-surgical periodontal therapy at 3 months, after non-surgical periodontal therapy at 6 months,
serum and GCF matrix metalloproteinase 8 (MMP8) level
MMP-8 levels in serum and GCF will be measured with biochemical kits.
Measured: baseline, after non-surgical periodontal therapy at 3 months, after non-surgical periodontal therapy at 6 months,
serum total antioxidant status (TAS) level
TAS levels in serum will be measured with biochemical kits.
Measured: baseline, after non-surgical periodontal therapy at 3 months, after non-surgical periodontal therapy at 6 months,
serum total oxidant status (TAS) level
TOS levels in serum will be measured with biochemical kits.
Measured: baseline, after non-surgical periodontal therapy at 3 months, after non-surgical periodontal therapy at 6 months,
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2025
- Study start1 Mar 2024
- Primary completion18 Apr 2025
- Study completion18 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Peridontal DiseaseStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hatice Yemenoğlu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Hatice Yemenoğlu, Recep Tayyip Erdogan University Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06818045
- Sponsor's protocol ID
- RecepTayyipErdogan University
- Status last verified
- Apr 2024
- First submitted
- 2 Feb 2025
- Last updated
- 23 Apr 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The requested data can be shared in a way that protects patient personal information.
Publications
de Pablo P, Dietrich T, McAlindon TE. Association of periodontal disease and tooth loss with rheumatoid arthritis in the US population. J Rheumatol. 2008 Jan;35(1):70-6. Epub 2007 Nov 15.
PubMed 18050377Yemenoglu H, Beder M, Cure O, Kose O, Arpa M, Atak M, Bostan SA. The effect of anti-tumor necrosis factor-alpha and nonsurgical periodontal therapy in individuals with rheumatoid arthritis. BMC Oral Health. 2026 May 13;26(1):1259. doi: 10.1186/s12903-026-08538-6.
PubMed 42129776
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Effect of Nonsurgical Periodontal Treatment Applied Together With Anti-TNF-α on Alveolar Bone Loss and Oxidative Stress in Patients With Rheumatoid Arthritis and Periodontitis
- ClinicalTrials.gov ID
- NCT06818045
- Acronym / sponsor ID
- RecepTayyipErdogan University
- Conditions
- Peridontal Disease, Rheumatic Arthritis
- Keywords
- rheumatoid arthritis, periodontal disease, inflammation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Hatice YemenoğluUniversity, hospital or other
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- 18 Apr 2025 (actual)
- Study completion
- 18 Apr 2025 (actual)
- First posted
- 10 Feb 2025 (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 multifactorial disease of the periodontium that can lead to destruction of the alveolar bone and supporting connective tissue and subsequent tooth loss. Recent studies have shown that periodontitis is associated with age, smoking habits, genetic predisposition, socioeconomic status, and various systemic diseases such as diabetes mellitus, atherosclerosis, obesity, osteoporosis, and rheumatoid arthritis (RA). RA is a chronic, systemic inflammatory disease of unknown etiology that primarily affects the joints. Periodontitis and RA have similar clinical and pathogenic features. Clinically, both diseases are characterized by local destruction of hard and soft tissues. Their pathogenesis involves the release of cytokines and matrix metalloproteinases (MMPs) from inflammatory cells. Expression of proinflammatory cytokines such as tumor necrosis factor-alpha (TNF-α) leads to the release of high levels of inflammatory mediators that cause bone destruction and the spread of inflammation. TNF-α is the main regulatory cytokine in both RA and periodontitis. TNF-α inhibitors (anti-TNF-α) reduce the number of inflammatory cells, osteoclast formation and bone loss. In addition, many immunological processes have been identified that are similar to both diseases. Autoreactive T cells, natural killer cells, heat shock proteins, autoantibodies and genetic factors are reported to play an important role in the inflammatory pathway of RA and periodontitis.
Recently, TNF-α blocking agents (anti-TNF-α) have been developed and used for the treatment of RA. Animal and human studies have suggested that anti-TNF-α treatment may reduce the severity of periodontitis.
The aim of this study was to investigate the effect of nonsurgical periodontal treatment combined with anti-TNF-α on alveolar bone loss and oxidative stress in individuals with RA and periodontitis.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| control | Experimental | Procedure: Non Surgical Periodontal Treatment, Other: Periodontal measurements will be performed, Other: biochemical measurements, Other: No medication will be administered to patients. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Being between the ages of 18-65,
- Having a confirmed diagnosis of Rheumatoid Arthritis (RA),
- Having a diagnosis of Stage III-IV periodontitis,
- Having at least 20 teeth,
Key exclusion criteria (5 listed)
- Having used antibiotics for the 3 months before the study,
- Being pregnant and lactating,
- Having received periodontal treatment in the last 6 months,
- Being diabetic.
- Smoking.
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 |
|---|---|---|
| Non Surgical Periodontal TreatmentThis procedure will be applied to all patients. All patients received nonsurgical periodontal treatment. Scaling root planing and subgingival debridement were performed. | Procedure or surgery | control |
| Periodontal measurements will be performedPeriodontal measurements will be performed on all patients (plaque index, gingival index, bleeding on probing, periodontal pocket depth, clinical attachment loss). | Other | control |
| biochemical measurementsSerum and gingival crevicular fluid (GCF) samples will be collected from patients for biochemical evaluations. | Other | control |
| No medication will be administered to patients.No medication will be administered to patients. | Other | control |
Primary outcome
Periodontal pocket depth
Time frame: baseline, 3rd month after non-surgical periodontal therapy, 6th month after non-surgical periodontal therapy
The distance between the pocket base and the gingival margin is measured
clinical attachment loss
Time frame: baseline, 3rd month after non-surgical periodontal therapy, 6th month after non-surgical periodontal therapy
The distance between the pocket base and the cementoenamel junction is measured
5 secondary outcomes
serum and GCF receptor activator nuclear kappa B ligand (RANKL) level
Time frame: baseline, after non-surgical periodontal therapy at 3 months, after non-surgical periodontal therapy at 6 months,
serum and GCF osteoprotegrin (OPG) level
Time frame: baseline, after non-surgical periodontal therapy at 3 months, after non-surgical periodontal therapy at 6 months,
serum and GCF matrix metalloproteinase 8 (MMP8) level
Time frame: baseline, after non-surgical periodontal therapy at 3 months, after non-surgical periodontal therapy at 6 months,
serum total antioxidant status (TAS) level
Time frame: baseline, after non-surgical periodontal therapy at 3 months, after non-surgical periodontal therapy at 6 months,
serum total oxidant status (TAS) level
Time frame: baseline, after non-surgical periodontal therapy at 3 months, after non-surgical periodontal therapy at 6 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 Apr 2025.
- Results publication: PubMed 18050377de Pablo P, Dietrich T, McAlindon TE. Association of periodontal disease and tooth loss with rheumatoid arthritis in the US population. J Rheumatol. 2008 Jan;35(1):70-6. Epub 2007 Nov 15.
- Derived from this study: PubMed 42129776Yemenoglu H, Beder M, Cure O, Kose O, Arpa M, Atak M, Bostan SA. The effect of anti-tumor necrosis factor-alpha and nonsurgical periodontal therapy in individuals with rheumatoid arthritis. BMC Oral Health. 2026 May 13;26(1):1259. doi: 10.1186/s12903-026-08538-6.
- Individual participant dataSharing planned: Yes. The requested data can be shared in a way that protects patient personal information.
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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 Non Surgical Periodontal Treatment, Periodontal measurements will be performed and biochemical measurements in people with Peridontal Disease and Rheumatic Arthritis, run by Hatice Yemenoğlu 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 23 Apr 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?
Periodontal pocket depth (time frame: baseline, 3rd month after non-surgical periodontal therapy, 6th month after non-surgical periodontal therapy). The study lists 2 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 NCT06818045, which also lists 2 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 23 Apr 2025.