PeriodontitisESPERANCT02779179
Therapeutic Management of Periodontitis and Clinical Manifestations of Rheumatoid Arthritis
A study testing Periodontal treatment in people with Periodontitis and Rheumatoid Arthritis, run by University Hospital, Toulouse at 2 sites in France.
Trial summary
Although RA pathomechanisms remains incompletely understood, periodontitis and RA share pathogenic features : genetic and environmental influences, chronic inflammatory disease, immunoregulatory imbalance, bacterial factors, persistence of antigen/peptide and clinical factors (conjunctive and hard tissues… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Periodontitis, Rheumatoid Arthritis
- What is being tested?
- Periodontal treatment
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 2 sitesFrance
- Study dates
- Nov 2010to Nov 2016
- 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
- rheumatoid arthritis diagnosed for at least one year
- DAS28 score between 3.2 and 5.1
- no change to medication, dosage or formulation in RA treatment during the 3 months preceding the screening visit
- subject available for all study visits over three months in the Dental Care Departments (V1 to V4)
- subjects with at least six natural teeth with root
- subject with periodontitis, defined by the presence of one site with periodontal probing depth ≥ 4 mm and clinical attachment level ≥ 3 mm on at least 4 teeth.
- subject has given his informed consent: 1 week cooling-off period
Who cannot join
- subject will not qualify for enrolment if he presents at least one of the following: acute oral infection, acute oral pain (including pulpitis), suspicious oral mucosal lesion, severe oral inflammation unrelated to periodontal conditions, or need for immediate tooth extractions
- have a planned hospitalization within 4 months after the screening visit
- subject suffering from one or more known infectious diseases (HIV, hepatitis, infectious mononucleosis),
- subject suffering from known clinically significant renal disease (creatinine clearance <60 ml/min), or liver disease,
- unbalanced diabetes
- have a known risk of endocarditis,
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- have a permanent pacemaker,
- subject taking antithrombotic treatment,
- subject having severe difficulties in understanding written and spoken French
- for females: are pregnant or intending to become pregnant, or lactating
- subject suffering from a chronic disorder that requires chronic or intermittent use of antibiotics,
- subject having known hypersensitivity to chlorhexidine gluconate
- are participating in another intervention study
- have known contraindications to both amoxicillin and clindamycin
- have known contraindications to dental local anesthetic.
Trial locations and contacts
2 sites in 1 country.
France2 sites
CHU de Bordeaux
Bordeaux, 33000
Pôle Odontologie Hôpital Purpan - Pavillon Rayer
Toulouse, 31059
About this study
Official title: Efficacy of Therapeutic Management of Periodontitis on the Clinical Manifestations of Rheumatoid Arthritis: the Randomized, Controlled ESPERA Trial.
Although RA pathomechanisms remains incompletely understood, periodontitis and RA share pathogenic features : genetic and environmental influences, chronic inflammatory disease, immunoregulatory imbalance, bacterial factors, persistence of antigen/peptide and clinical factors (conjunctive and hard tissues destruction). Several hypothesis can be evocated : Gram negative bacterial systemic spreading, inflammatory transmitter substance systemic spreading (IL1, IL6, IL17, PGE2), systemic spreading of bacterial degradation products (LPS for example).
Currently Porphyromonas gingivalis (PG) might be a susceptibility factor to RA because PG has an enzyme, the peptidylarginine deiminase leading to auto antibodies creation and RA increasing. As periodontitis, RA is chronic disease with a cyclic increase evolution, needing a complex pluridisciplinary treatment approach. Recent studies have reported an increased prevalence of RA patients with periodontal disease. Others studies show that periodontal treatment induces a significant decrease of the sedimentation rate and of the DAS28. Periodontitis is suspected to be an independent, aggravating factor in patients with RA (given the definition from NIH : an aggravating factor is something that makes a condition worse). So periodontal treatment cannot be considered as a RA treatment per se. But it is hypothesised that treating periodontitis in RA patients showing signs of periodontitis could result in improvement in RA disease activity. To date the role of periodontitis as an aggravating factor in these patients remains unclear, and only RCT designs can reasonably be used to test this causal hypothesis. There still remains some RA patients who have persistent symptoms and frequent exacerbations despite specialist care and continuous treatment, so results of treating aggravating factors are needed. As the majority of patients will benefit from a systematic evaluation and treatment of aggravating factors, the periodontal treatment strategy need to be tested.
Read more
The aim of this randomised controlled trial is to assess the effectiveness of periodontal treatment for rheumatoid arthritis patients.
To assess the effectiveness of periodontal treatment to reduce the severity of rheumatoid arthritis (RA), in patients suffering from both periodontitis and rheumatoid arthritis. The hypothesis is that periodontal treatment reduce the severity of rheumatoid arthritis.
- Conditions
- Periodontitis, Rheumatoid Arthritis
- Being tested
- Periodontal treatment
- 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.
Periodontal treatmentProcedure or surgery
- Mechanical debridement (scaling, root planning, subgingival curettage)
- Antimicrobial therapy (systematically administered: amoxicillin or clindamycin).
- Antiseptic mouthrinses, gel or dentifrice
- Oral hygiene instructions (to educate and motivate patients to control the accumulation of plaque and calculus)
| Study group | Role | What they receive |
|---|---|---|
| Immediate Periodontal treatment group | Experimental | Not described Receives: Procedure: Periodontal treatment |
| Delayed Periodontal treatment Group | Active comparator | Not described Receives: Procedure: Periodontal treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of parodontitis therapeutic care as assessed by variation in DAS28 score
Measured: Day 15 and day 90
Secondary outcomes (3)
Evaluation of parodontitis therapeutic care as assessed by variation in ACR 20 score
Measured: Day 15 and day 90
Evaluation of parodontitis therapeutic care as assessed by variation in HAQ score
Measured: Day 15 and day 90
Evaluation of parodontitis therapeutic care as assessed by variation in GOHAI score
Measured: Day 15 and day 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2016 (estimated)
- Study startNov 2010
- Primary completionNov 2016
- Study completionNov 2016
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 PeriodontitisStudies of the same condition, open and under way.
- More trials run by University Hospital, ToulouseThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Paul MONSARRAT, MD, Principal investigator, Faculté de chirurgie dentaire - Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02779179
- Sponsor's protocol ID
- 10 046 08
- Other IDs
- 2010-A01193-36
- Acronym
- ESPERA
- Status last verified
- Nov 2018
- First submitted
- 10 Jul 2015
- Last updated
- 10 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Monsarrat P, Vergnes JN, Cantagrel A, Algans N, Cousty S, Kemoun P, Bertrand C, Arrive E, Bou C, Sedarat C, Schaeverbeke T, Nabet C, Sixou M. Effect of periodontal treatment on the clinical parameters of patients with rheumatoid arthritis: study protocol of the randomized, controlled ESPERA trial. Trials. 2013 Aug 14;14:253. doi: 10.1186/1745-6215-14-253.
PubMed 23945051Monsarrat P, Fernandez de Grado G, Constantin A, Willmann C, Nabet C, Sixou M, Cantagrel A, Barnetche T, Mehsen-Cetre N, Schaeverbeke T, Arrive E, Vergnes JN; ESPERA Group. The effect of periodontal treatment on patients with rheumatoid arthritis: The ESPERA randomised controlled trial. Joint Bone Spine. 2019 Oct;86(5):600-609. doi: 10.1016/j.jbspin.2019.02.006. Epub 2019 Feb 26.
PubMed 30822490
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Therapeutic Management of Periodontitis on the Clinical Manifestations of Rheumatoid Arthritis: the Randomized, Controlled ESPERA Trial.
- ClinicalTrials.gov ID
- NCT02779179
- Acronym / sponsor ID
- ESPERA / 10 046 08
- Conditions
- Periodontitis, Rheumatoid Arthritis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- Nov 2010 (actual)
- Primary completion
- Nov 2016 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 20 May 2016 (estimated)
- 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.
Although RA pathomechanisms remains incompletely understood, periodontitis and RA share pathogenic features : genetic and environmental influences, chronic inflammatory disease, immunoregulatory imbalance, bacterial factors, persistence of antigen/peptide and clinical factors (conjunctive and hard tissues destruction). Several hypothesis can be evocated : Gram negative bacterial systemic spreading, inflammatory transmitter substance systemic spreading (IL1, IL6, IL17, PGE2), systemic spreading of bacterial degradation products (LPS for example).
Currently Porphyromonas gingivalis (PG) might be a susceptibility factor to RA because PG has an enzyme, the peptidylarginine deiminase leading to auto antibodies creation and RA increasing. As periodontitis, RA is chronic disease with a cyclic increase evolution, needing a complex pluridisciplinary treatment approach. Recent studies have reported an increased prevalence of RA patients with periodontal disease. Others studies show that periodontal treatment induces a significant decrease of the sedimentation rate and of the DAS28. Periodontitis is suspected to be an independent, aggravating factor in patients with RA (given the definition from NIH : an aggravating factor is something that makes a condition worse). So periodontal treatment cannot be considered as a RA treatment per se. But it is hypothesised that treating periodontitis in RA patients showing signs of periodontitis could result in improvement in RA disease activity. To date the role of periodontitis as an aggravating factor in these patients remains unclear, and only RCT designs can reasonably be used to test this causal hypothesis. There still remains some RA patients who have persistent symptoms and frequent exacerbations despite specialist care and continuous treatment, so results of treating aggravating factors are needed. As the majority of patients will benefit from a systematic evaluation and treatment of aggravating factors, the periodontal treatment strategy need to be tested.
The aim of this randomised controlled trial is to assess the effectiveness of periodontal treatment for rheumatoid arthritis patients.
To assess the effectiveness of periodontal treatment to reduce the severity of rheumatoid arthritis (RA), in patients suffering from both periodontitis and rheumatoid arthritis. The hypothesis is that periodontal treatment reduce the severity of rheumatoid arthritis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Immediate Periodontal treatment group | Experimental | Procedure: Periodontal treatment |
| Delayed Periodontal treatment Group | Active comparator | Procedure: Periodontal treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- rheumatoid arthritis diagnosed for at least one year
- DAS28 score between 3.2 and 5.1
- no change to medication, dosage or formulation in RA treatment during the 3 months preceding the screening visit
- subject available for all study visits over three months in the Dental Care Departments (V1 to V4)
- subjects with at least six natural teeth with root
Key exclusion criteria (15 listed)
- subject will not qualify for enrolment if he presents at least one of the following: acute oral infection, acute oral pain (including pulpitis), suspicious oral mucosal lesion, severe oral inflammation unrelated to periodontal conditions, or need for immediate tooth extractions
- have a planned hospitalization within 4 months after the screening visit
- subject suffering from one or more known infectious diseases (HIV, hepatitis, infectious mononucleosis),
- subject suffering from known clinically significant renal disease (creatinine clearance <60 ml/min), or liver disease,
- unbalanced diabetes
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 |
|---|---|---|
| Periodontal treatment* Mechanical debridement (scaling, root planning, subgingival curettage) * Antimicrobial therapy (systematically administered: amoxicillin or clindamycin). * Antiseptic mouthrinses, gel or dentifrice * Oral hygiene instructions (to educate and motivate patients to control the accumulation of plaque and calculus) | Procedure or surgery | Delayed Periodontal treatment Group, Immediate Periodontal treatment group |
Primary outcome
Evaluation of parodontitis therapeutic care as assessed by variation in DAS28 score
Time frame: Day 15 and day 90
3 secondary outcomes
Evaluation of parodontitis therapeutic care as assessed by variation in ACR 20 score
Time frame: Day 15 and day 90
Evaluation of parodontitis therapeutic care as assessed by variation in HAQ score
Time frame: Day 15 and day 90
Evaluation of parodontitis therapeutic care as assessed by variation in GOHAI score
Time frame: Day 15 and day 90
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 10 Dec 2025.
- Results publication: PubMed 23945051Monsarrat P, Vergnes JN, Cantagrel A, Algans N, Cousty S, Kemoun P, Bertrand C, Arrive E, Bou C, Sedarat C, Schaeverbeke T, Nabet C, Sixou M. Effect of periodontal treatment on the clinical parameters of patients with rheumatoid arthritis: study protocol of the randomized, controlled ESPERA trial. Trials. 2013 Aug 14;14:253. doi: 10.1186/1745-6215-14-253.
- Results publication: PubMed 30822490Monsarrat P, Fernandez de Grado G, Constantin A, Willmann C, Nabet C, Sixou M, Cantagrel A, Barnetche T, Mehsen-Cetre N, Schaeverbeke T, Arrive E, Vergnes JN; ESPERA Group. The effect of periodontal treatment on patients with rheumatoid arthritis: The ESPERA randomised controlled trial. Joint Bone Spine. 2019 Oct;86(5):600-609. doi: 10.1016/j.jbspin.2019.02.006. Epub 2019 Feb 26.
- 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.
Paul MONSARRAT, MD principal investigator
Faculté de chirurgie dentaire - Toulouse
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Periodontal treatment in people with Periodontitis and Rheumatoid Arthritis, run by University Hospital, Toulouse at 2 sites in France.
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 7 inclusion and 15 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 10 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. 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?
Evaluation of parodontitis therapeutic care as assessed by variation in DAS28 score (time frame: Day 15 and day 90). 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 NCT02779179, 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 10 Dec 2025.