PeriodontitisNCT05271890
Rheumatoid Arthritis and Treatment of Periodontitis: a Randomized Clinical Trial.
A study testing Immediate non-surgical periodontal treatment and oral hygiene instructions in people with Periodontitis and Arthritis, Rheumatoid, run by University of Pisa at 1 site in Italy.
Trial summary
Periodontitis is an infectious disease defined by bacteria-mediated inflammation of the supporting tissues of the teeth that if left untreated may ultimately lead to the destruction of the attachment apparatus, culminating in tooth loss. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Periodontitis, Arthritis, Rheumatoid
- What is being tested?
- Immediate non-surgical periodontal treatment and oral hygiene instructions
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteItaly
- Study dates
- 25 Aug 2014to Feb 2019
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects affected by rheumatoid arthritis with a stable therapeutic regimen for at least 3 months preceding the study participation
- Subjects with at least 15 teeth
- Subjects affected by severe generalized periodontitis that had undergone no periodontal treatment in the 6 months preceding the study participation
Who cannot join
- Age younger than 18 years
- Pregnancy or breastfeeding
- Edentulism
- Diagnosis of other autoimmune pathologies, liver disease, diabetes, early/juvenile arthritis or syndromes associated with RA
Trial locations and contacts
1 site in 1 country.
About this study
Periodontitis is an infectious disease defined by bacteria-mediated inflammation of the supporting tissues of the teeth that if left untreated may ultimately lead to the destruction of the attachment apparatus, culminating in tooth loss. Rheumatoid arthritis is a chronic destructive inflammatory disease characterized by autoantibodies and the accumulation and persistence of an inflammatory infiltrate in the synovial membrane that leads to synovitis and the destruction of the joint architecture. The objective of this study was to evaluate the possible beneficial additional value of non-surgical periodontal therapy on systemic markers of inflammation and clinical and serological parameters of rheumatoid arthritis.
- Conditions
- Periodontitis, Arthritis, Rheumatoid
- Being tested
- Immediate non-surgical periodontal treatment and oral hygiene instructions
- Keywords
- Periodontitis, Rheumatoid arthritis, Treatment of periodontitis
- 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.
Immediate non-surgical periodontal treatment and oral hygiene instructionsProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Immediate periodontal treatment | Experimental | Subjects assigned to this group were receiving non-surgical periodontal treatment as well as oral hygiene instructions immediately after their inclusion. All subjects were undergone full periodontal and rheumatologic clinical examinations both at baseline and 90 days after the completion of the treatment. Blood collection for the analysis of the serum concentration of CRP, ESR, Fibrinogen, IL-6 and TNF-α was also performed at baseline and 90 days after periodontal treatment. Receives: Procedure: Immediate non-surgical periodontal treatment and oral hygiene instructions |
| Delayed periodontal treatment | No intervention | Subjects assigned to this group were receiving non-surgical periodontal treatment 90 days after baseline evaluation. All subjects were undergone full periodontal and rheumatologic clinical examinations both at baseline and 90 days after. Blood collection for the analysis of the serum concentration of CRP, ESR, Fibrinogen, IL-6 and TNF-α was also performed at baseline and 90 days after. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease Activity Score 28 (DAS-28)
Variation of DAS-28 90 days after periodontal treatment
Measured: 90 days
Secondary outcomes (4)
Erythrocyte Sedimentation Rate (ESR)
Variation of ESR 90 days after periodontal treatment
Measured: 90 days
C-Reactive Protein (CRP)
Variation of CRP 90 days after periodontal treatment
Measured: 90 days
Interleuchin-6 concentration (IL-6)
Variation of IL-6 90 days after periodontal treatment
Measured: 90 days
Oral Health Related Quality of Life (OHRQoL)
Variation of OHRQoL 90 days after periodontal treatment
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2022
- Study start25 Aug 2014
- Primary completionDec 2018
- Study completionFeb 2019
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.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pisa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Filippo Graziani, DDS MClinDent PhD, University of Pisa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05271890
- Sponsor's protocol ID
- Perioreuma
- Status last verified
- May 2022
- First submitted
- 27 Feb 2022
- Last updated
- 24 May 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rheumatoid Arthritis and Treatment of Periodontitis: a Randomized Clinical Trial.
- ClinicalTrials.gov ID
- NCT05271890
- Acronym / sponsor ID
- Perioreuma
- Conditions
- Periodontitis, Arthritis, Rheumatoid
- Keywords
- Periodontitis, Rheumatoid arthritis, Treatment of periodontitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of PisaUniversity, hospital or other
- Study start
- 25 Aug 2014 (actual)
- Primary completion
- Dec 2018 (actual)
- Study completion
- Feb 2019 (actual)
- First posted
- 9 Mar 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.
Periodontitis is an infectious disease defined by bacteria-mediated inflammation of the supporting tissues of the teeth that if left untreated may ultimately lead to the destruction of the attachment apparatus, culminating in tooth loss. Rheumatoid arthritis is a chronic destructive inflammatory disease characterized by autoantibodies and the accumulation and persistence of an inflammatory infiltrate in the synovial membrane that leads to synovitis and the destruction of the joint architecture. The objective of this study was to evaluate the possible beneficial additional value of non-surgical periodontal therapy on systemic markers of inflammation and clinical and serological parameters of rheumatoid arthritis.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Immediate periodontal treatment | Experimental | Procedure: Immediate non-surgical periodontal treatment and oral hygiene instructionsSubjects assigned to this group were receiving non-surgical periodontal treatment as well as oral hygiene instructions immediately after their inclusion. All subjects were undergone full periodontal and rheumatologic clinical examinations both at baseline and 90 days after the completion of the treatment. Blood collection for the analysis of the serum concentration of CRP, ESR, Fibrinogen, IL-6 and TNF-α was also performed at baseline and 90 days after periodontal treatment. |
| Delayed periodontal treatment | No intervention | –Subjects assigned to this group were receiving non-surgical periodontal treatment 90 days after baseline evaluation. All subjects were undergone full periodontal and rheumatologic clinical examinations both at baseline and 90 days after. Blood collection for the analysis of the serum concentration of CRP, ESR, Fibrinogen, IL-6 and TNF-α was also performed at baseline and 90 days after. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Subjects affected by rheumatoid arthritis with a stable therapeutic regimen for at least 3 months preceding the study participation
- Subjects with at least 15 teeth
- Subjects affected by severe generalized periodontitis that had undergone no periodontal treatment in the 6 months preceding the study participation
Key exclusion criteria (4 listed)
- Age younger than 18 years
- Pregnancy or breastfeeding
- Edentulism
- Diagnosis of other autoimmune pathologies, liver disease, diabetes, early/juvenile arthritis or syndromes associated with RA
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 |
|---|---|---|
| Immediate non-surgical periodontal treatment and oral hygiene instructions | Procedure or surgery | Immediate periodontal treatment |
Primary outcome
Disease Activity Score 28 (DAS-28)
Time frame: 90 days
Variation of DAS-28 90 days after periodontal treatment
4 secondary outcomes
Erythrocyte Sedimentation Rate (ESR)
Time frame: 90 days
C-Reactive Protein (CRP)
Time frame: 90 days
Interleuchin-6 concentration (IL-6)
Time frame: 90 days
Oral Health Related Quality of Life (OHRQoL)
Time frame: 90 days
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 24 May 2022.
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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 Immediate non-surgical periodontal treatment and oral hygiene instructions in people with Periodontitis and Arthritis, Rheumatoid, run by University of Pisa at 1 site in Italy.
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 4 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 24 May 2022. 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 Italy. 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?
Disease Activity Score 28 (DAS-28) (time frame: 90 days). 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 24 May 2022.