Arthritis, RheumatoidNCT05502601
Periodontal Therapy in Patients With Rheumatoid Arthritis
A study testing Non-surgical periodontal treatment in people with Arthritis, Rheumatoid and Periodontitis, run by Federal University of Rio Grande do Sul at 1 site in Peru.
Trial summary
Aim: A prospective randomized, controlled clinical trial comparing two groups of a cohort of Rheumatoid Arthritis (RA) patients with periodontal disease will be carried out to identify if the effect of non-surgical periodontal therapy is a predictor of remission/ low disease activity (LDA)-remission. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arthritis, Rheumatoid, Periodontitis
- What is being tested?
- Non-surgical 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
- 42 participants
- Where
- 1 sitePeru
- Study dates
- 15 Dec 2022to 1 May 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients of both sexes
- Age ≥16 years at the time of diagnosis and who do not meet criteria of overlap with any other autoimmune disease.
- Presence of six or more permanent teeth in the mouth, excluding third molars.
- Presence of periodontitis stage 3 or 4 with at least 2 non-adjacent teeth with insertion loss >=5mm, probing depth >=5mm and bleeding on probing according to Tonetti et al.[35].
- Willingness to attend all visits for the duration of the study.
Who cannot join
- Patients with Sjogren's syndrome
- - Severe ongoing systemic infection.
- - Associated dental infection
- - History of oral cavity cancer or precancerous lesion.
- - Use of local or systemic antibiotics in the last 3 months (including tetracyclines or other medication that could change the periodontal evaluation in the investigator's opinion, such as heparin alendronate, antivitamin K).
- - Medications that induce gingival hyperplasia (such as phenytoin, warfarin or cyclosporine).
Show all 9Show fewer
- - Pregnant or breastfeeding women
- - Participation in another intervention study.
- Patients with a history of PD treatment in the last 6 months or previous dental surgery)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Non-surgical Periodontal Therapy in the Systemic and Clinical Conditions of Patients With Rheumatoid Arthritis: a 6-months Randomized Controlled Trial
Aim: A prospective randomized, controlled clinical trial comparing two groups of a cohort of Rheumatoid Arthritis (RA) patients with periodontal disease will be carried out to identify if the effect of non-surgical periodontal therapy is a predictor of remission/ low disease activity (LDA)-remission.
Methods: 42 patients with RA and periodontitis from the RA Almenara cohort will be included (ACR 1987 and or ACR/EULAR 2010 criteria with more than 16 years old at diagnosis); those with <6 teeth, current infections, cancer or oral precancerous lesions, diabetics, Sjogren's syndrome, use of antibiotics or drugs associated with dry mouth and dental surgery, will be excluded. Periodontal Disease was defined by the presence of periodontitis stage 3 or 4 with at least 2 non-adjacent teeth with insertion loss >=5mm, probing depth >=5mm and bleeding on probing according with the 2018 periodontitis diagnostic criteria.
Two RA patients groups will be follow up by monthly visits. Patients will be divided into two groups (intervention and no intervention treatment). PD treatment will be performed by a qualified periodontist. No intervention group will receive PD treatment after 6 month visit because ethical principles. Disease activity will be determined according with DAS 28index, Clinical Disease Activity Index (CDAI) and Simple Disease Activity Index (SDAI) scores, C-reactive protein (CRP), the erythrocyte sedimentation rate (ESR), and rheumatoid factor levels will be registered before and after PD treatment (baseline, 3 and 6 months visits), and the differences between the groups will be analyzed and compared. Periodontal parameters including probing depth (PD), clinical attachment loss, and sulcus bleeding index (SBI) will be correlated with the factor levels.
- Conditions
- Arthritis, Rheumatoid, Periodontitis
- Being tested
- Non-surgical periodontal treatment
- Keywords
- C-reactive protein, Periodontal diseases, Periodontitis, Rheumatoid arthritis, Scaling and root planning
- Medical subject headings
- Arthritis, Rheumatoid, Periodontitis, Periodontal Diseases
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
Also called Scaling and root planing
SRP will be performed under local anesthesia during a single, 2-hour, full-mouth ultrasonic and hand instrument debridement using curettes.
Oral hygiene instructions (to educate and motivate patients to control the accumulation of plaque and calculus)
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | The control group will be comprised by those who will not receive any specific oral care intervention. For ethical reasons, the control group will receive periodontal therapy at the Endo of the study (after 6 months). In those cases presenting periodontal disease progression in a single tooth, the patients will be treated and withdrawn from the study |
| Non-surgical periodontal treatment | Active comparator | Periodontal treatment will be performed with scaling and root planning (SRP).SRP will be performed under local anesthesia during a single, 2-hour, full-mouth ultrasonic and hand instrument debridement using curettes.
Oral hygiene instructions (patient education and motivation to control plaque and calculus accumulation) Receives: Procedure: Non-surgical periodontal treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in the Disease Activity Score with 28-joint counts (DAS 28)
The DAS28 includes a 28-swollen joint count (28SJC), 28-tender joint count (28TJC), ESR, and a patient global assessment of disease activity (PtGA) or GH (General Health) assessment on a VAS. It may also be calculated using C-reactive protein (CRP) level instead of Westergren ESR the unabbreviated scale title: Disease Activity Score (28-joint counts) A score greater than 5.1 indicates active disease and less than 3.2 indicates well-controlled disease. A score of less of than 2.6 indicates remission
Measured: Baseline, 3 and 6 months after treatment
Changes in the Simplified disease activity index (SDAI)
The SDAI includes a 28-swollen joint count (28SJC), 28-tender joint count (28TJC), patient global assessment of disease activity (PtGA) on a 10-cm visual analog scale (VAS), provider global assessment of disease activity (PrGA) on a 10-cm VAS, and C-reactive protein (CRP) level in mg/dl.
The unabbreviated scale title: Simplified disease SDAI is calculated as follows: SDAI = SJC + TJC +PtGA + EGA (Evaluator Global disease Activity) + CRP.
activity index The SDAI has range from 0 to 86. higher scores mean a worse outcome.
Measured: Baseline, 3 and 6 months after treatment
Changes in the Clinical disease activity index (CDAI)
The CDAI includes a 28-swollen joint count (28SJC), 28-tender joint count (28TJC), patient global assessment of disease activity (PtGA) on a 10-cm visual analog scale (VAS), and provider global assessment of disease activity (PrGA) on a 10-cm VAS
The unabbreviated scale title: Clinical disease activity index The CDAI has range from 0 to 76. higher scores mean a worse outcome.
Measured: Baseline, 3 and 6 months after treatment
Changes in Antibodies to cyclic citrullinated protein (anti-CCP)
measurement of CCP (cyclic citrullinated peptide) antibodies in the blood
Measured: Baseline, 3 and 6 months after treatment
Changes in rheumatoid factor (RF)
measurement of the amount of the RF antibody in the blood
Measured: Baseline, 3 and 6 months after treatment
Changes in erythrocyte sedimentation rate (ESR)
measurement of the erythrocyte sedimentation rate in a test tube
Measured: Baseline, 3 and 6 months after treatment
C-reactive protein (CRP)
measurement of the level of c-reactive protein (CRP) in your blood.
Measured: Baseline, 3 and 6 months after treatment
Secondary outcomes (4)
Changes in Probing pocket depth (PPD)
Measurement of pocket depth with periodontal probe in 6 sites per tooth
Measured: Baseline, 3 and 6 months after treatment
Changes in Clinical attachment level (CAL)
Measurement from the cemento-enamel junction to the total probing depth in 6 sites per tooth
Measured: Baseline, 3 and 6 months after treatment
Changes in Bleeding on probing (BOP)
Bleeding present or absent within 20 s after palpation in 6 sites per tooth
Measured: Baseline, 3 and 6 months after treatment
Changes in Plaque index (PI)
Presence or absence of bacterial plaque in 6 sites per tooth
Measured: Baseline, 3 and 6 months after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2022
- Study start15 Dec 2022 (estimated)
- Primary completion1 May 2024 (estimated)
- Study completion1 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Arthritis, RheumatoidStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Federal University of Rio Grande do Sul
- Sponsor type
- University, hospital or other
- Collaborators
- Universidad Científica del Sur
- Responsible party
- Principal investigator, Alex Nogueira Haas, Federal University of Rio Grande do Sul
- Investigators
- Andrea Vergara, Principal investigator, Universidad Cientifica del Sur
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05502601
- Sponsor's protocol ID
- CientificaDelSur
- Status last verified
- Nov 2022
- First submitted
- 1 Apr 2022
- Last updated
- 7 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Cheng Z, Meade J, Mankia K, Emery P, Devine DA. Periodontal disease and periodontal bacteria as triggers for rheumatoid arthritis. Best Pract Res Clin Rheumatol. 2017 Feb;31(1):19-30. doi: 10.1016/j.berh.2017.08.001. Epub 2017 Sep 1.
PubMed 29221594Genco RJ, Sanz M. Clinical and public health implications of periodontal and systemic diseases: An overview. Periodontol 2000. 2020 Jun;83(1):7-13. doi: 10.1111/prd.12344.
PubMed 32385880Gabriel SE, Michaud K. Epidemiological studies in incidence, prevalence, mortality, and comorbidity of the rheumatic diseases. Arthritis Res Ther. 2009;11(3):229. doi: 10.1186/ar2669. Epub 2009 May 19.
PubMed 19519924Schneeberger EE, Citera G, Maldonado Cocco JA, Salcedo M, Chiardola F, Rosemffet MG, Marengo MF, Papasidero S, Chaparro Del Moral R, Rillo OL, Bellomio V, Lucero E, Spindler A, Berman A, Duartes Noe D, Barreira JC, Lazaro MA, Paira SO. Factors associated with disability in patients with rheumatoid arthritis. J Clin Rheumatol. 2010 Aug;16(5):215-8. doi: 10.1097/RHU.0b013e3181e92d25.
PubMed 20577095Aletaha D, Neogi T, Silman AJ, Funovits J, Felson DT, Bingham CO 3rd, Birnbaum NS, Burmester GR, Bykerk VP, Cohen MD, Combe B, Costenbader KH, Dougados M, Emery P, Ferraccioli G, Hazes JM, Hobbs K, Huizinga TW, Kavanaugh A, Kay J, Kvien TK, Laing T, Mease P, Menard HA, Moreland LW, Naden RL, Pincus T, Smolen JS, Stanislawska-Biernat E, Symmons D, Tak PP, Upchurch KS, Vencovsky J, Wolfe F, Hawker G. 2010 Rheumatoid arthritis classification criteria: an American College of Rheumatology/European League Against Rheumatism collaborative initiative. Arthritis Rheum. 2010 Sep;62(9):2569-81. doi: 10.1002/art.27584.
PubMed 20872595Zhao X, Liu Z, Shu D, Xiong Y, He M, Xu S, Si S, Guo B. Association of Periodontitis with Rheumatoid Arthritis and the Effect of Non-Surgical Periodontal Treatment on Disease Activity in Patients with Rheumatoid Arthritis. Med Sci Monit. 2018 Aug 20;24:5802-5810. doi: 10.12659/MSM.909117.
PubMed 30124222Ceccarelli F, Saccucci M, Di Carlo G, Lucchetti R, Pilloni A, Pranno N, Luzzi V, Valesini G, Polimeni A. Periodontitis and Rheumatoid Arthritis: The Same Inflammatory Mediators? Mediators Inflamm. 2019 May 5;2019:6034546. doi: 10.1155/2019/6034546. eCollection 2019.
PubMed 31191116Calderaro DC, Correa JD, Ferreira GA, Barbosa IG, Martins CC, Silva TA, Teixeira AL. Influence of periodontal treatment on rheumatoid arthritis: a systematic review and meta-analysis. Rev Bras Reumatol Engl Ed. 2017 May-Jun;57(3):238-244. doi: 10.1016/j.rbre.2016.11.011. Epub 2017 Jan 4. English, Portuguese.
PubMed 28535896Silvestre FJ, Silvestre-Rangil J, Bagan L, Bagan JV. Effect of nonsurgical periodontal treatment in patients with periodontitis and rheumatoid arthritis: A systematic review. Med Oral Patol Oral Cir Bucal. 2016 May 1;21(3):e349-54. doi: 10.4317/medoral.20974.
PubMed 26946202Sun J, Zheng Y, Bian X, Ge H, Wang J, Zhang Z. Non-surgical periodontal treatment improves rheumatoid arthritis disease activity: a meta-analysis. Clin Oral Investig. 2021 Aug;25(8):4975-4985. doi: 10.1007/s00784-021-03807-w. Epub 2021 Jan 29.
PubMed 33515120
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Non-surgical Periodontal Therapy in the Systemic and Clinical Conditions of Patients With Rheumatoid Arthritis: a 6-months Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05502601
- Acronym / sponsor ID
- CientificaDelSur
- Conditions
- Arthritis, Rheumatoid, Periodontitis
- Keywords
- C-reactive protein, Periodontal diseases, Periodontitis, Rheumatoid arthritis, Scaling and root planning
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Federal University of Rio Grande do SulUniversity, hospital or other
- Collaborators
- Universidad Científica del Sur
- Study start
- 15 Dec 2022 (estimated)
- Primary completion
- 1 May 2024 (estimated)
- Study completion
- 1 May 2025 (estimated)
- First posted
- 16 Aug 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.
Aim: A prospective randomized, controlled clinical trial comparing two groups of a cohort of Rheumatoid Arthritis (RA) patients with periodontal disease will be carried out to identify if the effect of non-surgical periodontal therapy is a predictor of remission/ low disease activity (LDA)-remission.
Methods: 42 patients with RA and periodontitis from the RA Almenara cohort will be included (ACR 1987 and or ACR/EULAR 2010 criteria with more than 16 years old at diagnosis); those with <6 teeth, current infections, cancer or oral precancerous lesions, diabetics, Sjogren's syndrome, use of antibiotics or drugs associated with dry mouth and dental surgery, will be excluded. Periodontal Disease was defined by the presence of periodontitis stage 3 or 4 with at least 2 non-adjacent teeth with insertion loss >=5mm, probing depth >=5mm and bleeding on probing according with the 2018 periodontitis diagnostic criteria.
Two RA patients groups will be follow up by monthly visits. Patients will be divided into two groups (intervention and no intervention treatment). PD treatment will be performed by a qualified periodontist. No intervention group will receive PD treatment after 6 month visit because ethical principles. Disease activity will be determined according with DAS 28index, Clinical Disease Activity Index (CDAI) and Simple Disease Activity Index (SDAI) scores, C-reactive protein (CRP), the erythrocyte sedimentation rate (ESR), and rheumatoid factor levels will be registered before and after PD treatment (baseline, 3 and 6 months visits), and the differences between the groups will be analyzed and compared. Periodontal parameters including probing depth (PD), clinical attachment loss, and sulcus bleeding index (SBI) will be correlated with the factor levels.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –The control group will be comprised by those who will not receive any specific oral care intervention. For ethical reasons, the control group will receive periodontal therapy at the Endo of the study (after 6 months). In those cases presenting periodontal disease progression in a single tooth, the patients will be treated and withdrawn from the study |
| Non-surgical periodontal treatment | Active comparator | Procedure: Non-surgical periodontal treatmentPeriodontal treatment will be performed with scaling and root planning (SRP).SRP will be performed under local anesthesia during a single, 2-hour, full-mouth ultrasonic and hand instrument debridement using curettes. Oral hygiene instructions (patient education and motivation to control plaque and calculus accumulation) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients of both sexes
- Age ≥16 years at the time of diagnosis and who do not meet criteria of overlap with any other autoimmune disease.
- Presence of six or more permanent teeth in the mouth, excluding third molars.
- Presence of periodontitis stage 3 or 4 with at least 2 non-adjacent teeth with insertion loss >=5mm, probing depth >=5mm and bleeding on probing according to Tonetti et al.[35].
- Willingness to attend all visits for the duration of the study.
Key exclusion criteria (9 listed)
- Patients with Sjogren's syndrome
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 treatmentAlso: Scaling and root planingSRP will be performed under local anesthesia during a single, 2-hour, full-mouth ultrasonic and hand instrument debridement using curettes. Oral hygiene instructions (to educate and motivate patients to control the accumulation of plaque and calculus) | Procedure or surgery | Non-surgical periodontal treatment |
Primary outcome
Changes in the Disease Activity Score with 28-joint counts (DAS 28)
Time frame: Baseline, 3 and 6 months after treatment
The DAS28 includes a 28-swollen joint count (28SJC), 28-tender joint count (28TJC), ESR, and a patient global assessment of disease activity (PtGA) or GH (General Health) assessment on a VAS. It may also be calculated using C-reactive protein (CRP) level instead of Westergren ESR the unabbreviated scale title: Disease Activity Score (28-joint counts) A score greater than 5.1 indicates active disease and less than 3.2 indicates well-controlled disease. A score of less of than 2.6 indicates remission
Changes in the Simplified disease activity index (SDAI)
Time frame: Baseline, 3 and 6 months after treatment
The SDAI includes a 28-swollen joint count (28SJC), 28-tender joint count (28TJC), patient global assessment of disease activity (PtGA) on a 10-cm visual analog scale (VAS), provider global assessment of disease activity (PrGA) on a 10-cm VAS, and C-reactive protein (CRP) level in mg/dl. The unabbreviated scale title: Simplified disease SDAI is calculated as follows: SDAI = SJC + TJC +PtGA + EGA (Evaluator Global disease Activity) + CRP. activity index The SDAI has range from 0 to 86. higher scores mean a worse outcome.
Changes in the Clinical disease activity index (CDAI)
Time frame: Baseline, 3 and 6 months after treatment
The CDAI includes a 28-swollen joint count (28SJC), 28-tender joint count (28TJC), patient global assessment of disease activity (PtGA) on a 10-cm visual analog scale (VAS), and provider global assessment of disease activity (PrGA) on a 10-cm VAS The unabbreviated scale title: Clinical disease activity index The CDAI has range from 0 to 76. higher scores mean a worse outcome.
Changes in Antibodies to cyclic citrullinated protein (anti-CCP)
Time frame: Baseline, 3 and 6 months after treatment
measurement of CCP (cyclic citrullinated peptide) antibodies in the blood
Changes in rheumatoid factor (RF)
Time frame: Baseline, 3 and 6 months after treatment
measurement of the amount of the RF antibody in the blood
Changes in erythrocyte sedimentation rate (ESR)
Time frame: Baseline, 3 and 6 months after treatment
measurement of the erythrocyte sedimentation rate in a test tube
C-reactive protein (CRP)
Time frame: Baseline, 3 and 6 months after treatment
measurement of the level of c-reactive protein (CRP) in your blood.
4 secondary outcomes
Changes in Probing pocket depth (PPD)
Time frame: Baseline, 3 and 6 months after treatment
Changes in Clinical attachment level (CAL)
Time frame: Baseline, 3 and 6 months after treatment
Changes in Bleeding on probing (BOP)
Time frame: Baseline, 3 and 6 months after treatment
Changes in Plaque index (PI)
Time frame: Baseline, 3 and 6 months after treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2022.
- Background: PubMed 29221594Cheng Z, Meade J, Mankia K, Emery P, Devine DA. Periodontal disease and periodontal bacteria as triggers for rheumatoid arthritis. Best Pract Res Clin Rheumatol. 2017 Feb;31(1):19-30. doi: 10.1016/j.berh.2017.08.001. Epub 2017 Sep 1.
- Background: PubMed 32385880Genco RJ, Sanz M. Clinical and public health implications of periodontal and systemic diseases: An overview. Periodontol 2000. 2020 Jun;83(1):7-13. doi: 10.1111/prd.12344.
- Background: PubMed 19519924Gabriel SE, Michaud K. Epidemiological studies in incidence, prevalence, mortality, and comorbidity of the rheumatic diseases. Arthritis Res Ther. 2009;11(3):229. doi: 10.1186/ar2669. Epub 2009 May 19.
- Background: PubMed 20577095Schneeberger EE, Citera G, Maldonado Cocco JA, Salcedo M, Chiardola F, Rosemffet MG, Marengo MF, Papasidero S, Chaparro Del Moral R, Rillo OL, Bellomio V, Lucero E, Spindler A, Berman A, Duartes Noe D, Barreira JC, Lazaro MA, Paira SO. Factors associated with disability in patients with rheumatoid arthritis. J Clin Rheumatol. 2010 Aug;16(5):215-8. doi: 10.1097/RHU.0b013e3181e92d25.
- Background: PubMed 20872595Aletaha D, Neogi T, Silman AJ, Funovits J, Felson DT, Bingham CO 3rd, Birnbaum NS, Burmester GR, Bykerk VP, Cohen MD, Combe B, Costenbader KH, Dougados M, Emery P, Ferraccioli G, Hazes JM, Hobbs K, Huizinga TW, Kavanaugh A, Kay J, Kvien TK, Laing T, Mease P, Menard HA, Moreland LW, Naden RL, Pincus T, Smolen JS, Stanislawska-Biernat E, Symmons D, Tak PP, Upchurch KS, Vencovsky J, Wolfe F, Hawker G. 2010 Rheumatoid arthritis classification criteria: an American College of Rheumatology/European League Against Rheumatism collaborative initiative. Arthritis Rheum. 2010 Sep;62(9):2569-81. doi: 10.1002/art.27584.
- Background: PubMed 30124222Zhao X, Liu Z, Shu D, Xiong Y, He M, Xu S, Si S, Guo B. Association of Periodontitis with Rheumatoid Arthritis and the Effect of Non-Surgical Periodontal Treatment on Disease Activity in Patients with Rheumatoid Arthritis. Med Sci Monit. 2018 Aug 20;24:5802-5810. doi: 10.12659/MSM.909117.
- Background: PubMed 31191116Ceccarelli F, Saccucci M, Di Carlo G, Lucchetti R, Pilloni A, Pranno N, Luzzi V, Valesini G, Polimeni A. Periodontitis and Rheumatoid Arthritis: The Same Inflammatory Mediators? Mediators Inflamm. 2019 May 5;2019:6034546. doi: 10.1155/2019/6034546. eCollection 2019.
- Background: PubMed 28535896Calderaro DC, Correa JD, Ferreira GA, Barbosa IG, Martins CC, Silva TA, Teixeira AL. Influence of periodontal treatment on rheumatoid arthritis: a systematic review and meta-analysis. Rev Bras Reumatol Engl Ed. 2017 May-Jun;57(3):238-244. doi: 10.1016/j.rbre.2016.11.011. Epub 2017 Jan 4. English, Portuguese.
- Background: PubMed 26946202Silvestre FJ, Silvestre-Rangil J, Bagan L, Bagan JV. Effect of nonsurgical periodontal treatment in patients with periodontitis and rheumatoid arthritis: A systematic review. Med Oral Patol Oral Cir Bucal. 2016 May 1;21(3):e349-54. doi: 10.4317/medoral.20974.
- Background: PubMed 33515120Sun J, Zheng Y, Bian X, Ge H, Wang J, Zhang Z. Non-surgical periodontal treatment improves rheumatoid arthritis disease activity: a meta-analysis. Clin Oral Investig. 2021 Aug;25(8):4975-4985. doi: 10.1007/s00784-021-03807-w. Epub 2021 Jan 29.
- 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.
Andrea Vergara principal investigator
Universidad Cientifica del Sur
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 in people with Arthritis, Rheumatoid and Periodontitis, run by Federal University of Rio Grande do Sul at 1 site in Peru.
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 5 inclusion and 9 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 7 Nov 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 Peru. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Andrea Vergara, MS (51994968218, avergarabuenaventura@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in the Disease Activity Score with 28-joint counts (DAS 28) (time frame: Baseline, 3 and 6 months after treatment). The study lists 7 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 NCT05502601, which also lists 10 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 7 Nov 2022.