Rheumatoid ArthritisNCT04658615
Periodontal Treatment in Rheumatoid Arthritis Patients
A study testing Non-surgical periodontal therapy in people with Rheumatoid Arthritis and Periodontitis, run by Universidad de Antioquia at 1 site in Colombia.
Trial summary
Periodontitis is a chronic disease that leads to the loss of teeth. It has been associated to rheumatoid arthritis (RA). Periodontal therapy (NSPT) has been shown to have systemic effects. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Rheumatoid Arthritis, Periodontitis
- What is being tested?
- Non-surgical periodontal therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteColombia
- Study dates
- 1 Jan 2019to 30 Jun 2021
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- age ≥ 18 years old; diagnosis of RA according to the American College of Rheumatology with DAS-28 score ≥ 3.2 and no change in RA medication in the previous 3 months;
- at least 15 teeth excluding third molars;
- ≥2 non-adjacent teeth interproximal sites with loss of periodontal attachment level (PAL) ≥ 2 mm; or buccal or oral PAL ≥3 mm with pocketing >3 mm is detectable at ≥2 teeth.
- Patients without RA met the same criteria except for the diagnosis of RA.
Who cannot join
- periodontal treatment or use of antibiotics in the previous 3 months.
- diabetes, liver disease, head and neck radiation therapy.
- pregnancy
- HIV
- use of cyclosporine.
- Smoking, use of hypertension and hyperlipidemia medication were not exclusion criteria and were recorded accordingly.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Non-surgical Periodontal Therapy (NSPT) in Patients With and Without Rheumatoid Arthritis (RA)
Periodontitis is a chronic disease that leads to the loss of teeth. It has been associated to rheumatoid arthritis (RA). Periodontal therapy (NSPT) has been shown to have systemic effects. The objective of this study was to compare the effects of non-surgical periodontal therapy on biochemical parameters of rheumatoid arthritis (RA), periodontal parameters and quality of life in patients with and without RA.
Adult patients with and RA and periodontitis can participate in the study. Participants benefit from the effects of conventional tooth cleaning (periodontal therapy) and oral hygiene instructions. There are no significant risk associated with periodontal therapy.
The study is conducted at the Universidad de Antioquia in Medellin, Colombia. The study is set to start 2019 and end mid 2021. The study is funded by a grant from the Universidad de Antioquia. Contact person: Javier Enrique Botero (javier.botero@udea.edu.co)
Read the detailed description
After participants are screened for inclusion, serum samples will be collected for the analysis of C-reactive protein (CRP; mg/L), rheumatoid factor (RF; UI/mL) and anti-citrullinated protein antibodies (ACPAs; UI/mL) in a reference laboratory. A complete periodontal chart will be carried out at six sites per tooth excluding third molars by a single experienced clinician using a calibrated probe (Hu-Friedy Mfg. Co.). Subgingival plaque samples will be collected by means of paper points inserted to the bottom of the pocket and processed immediately for culture analysis and detection of Porphyromonas gingivalis. RA patients will be examined by an experienced rheumatologist to determine their Disease Activity Score (DAS-28). All examinations will be taken at baseline and repeated 3 months after intervention.
Non-surgical periodontal therapy (NSPT) will be administered on the following 5 days of inclusion. A single 1-hour session of full-mouth debridement with an ultrasonic device will be carried out in each participant under local anesthesia by an experienced clinician. After NSPT is completed, each patient will receive oral hygiene instructions and oral care pack including toothbrush and toothpaste (toothbrush Vitis Encias Medium; Toothpaste Vitis Encias; Dentaid, Colombia).
Demographic ,clinical history as well as medication data for all participants will be collected. Periodontal parameters of PD (mm), PAL (mm) and BOP (%) will be recorded at each visit. The stage and grade of periodontitis will be established according to the new classification of periodontal diseases (Papapanou et al. 2018). The clinician who records data will not be blinded to the condition of the patients.
Sample size was calculated to detect a 50 % change in CRP with a power of >80% (alpha 0,05) which resulted in 15 per group (Cosgarea et al. 2018). Considering possible dropouts, 20 participants will be included per group. Randomization will not be performed since the purpose was to compare the effects of NSPT in patients with and without RA. The clinical investigator who records periodontal parameters will be calibrated for repeated measurements before patient inclusion (Kappa value was ≥0.80 for PAL and PD). Continuous variables will be presented as the mean and 95% confidence interval (CI) or median [interquartile range] when appropriate. Change in biochemical markers (CRP, RF, ACPAs) and periodontal parameters (PAL, PD, BOP, microbial counts) will be expressed as the delta (∆) from baseline to 3 months after intervention. Differences in means will be determined by the student t test for paired and unpaired samples or non-parametric tests when appropriate. Categorical variables will be presented as frequencies (%) and analyzed in contingency tables and X2. Logistic regression analysis for categorical variables and linear models will be used to test for associations and the odds ratio with 95%CI will be calculated. The primary analysis will be performed as intention to treat and then compared to per-protocol analysis results. The level of statistical significance will be set at 5% (P≤0,05).
- Conditions
- Rheumatoid Arthritis, Periodontitis
- Being tested
- Non-surgical periodontal therapy
- Medical subject headings
- Arthritis, Rheumatoid, Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-surgical periodontal therapyProcedure or surgery
A single 1-hour session of full-mouth debridement with an ultrasonic device under local anesthesia
| Study group | Role | What they receive |
|---|---|---|
| group with rheumatoid arthritis | Other | Non-surgical periodontal therapy (NSPT) Receives: Procedure: Non-surgical periodontal therapy |
| group without rheumatoid arthritis | Other | Non-surgical periodontal therapy (NSPT) Receives: Procedure: Non-surgical periodontal therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in C reactive protein
change in C-reactive protein levels (mg/L) measured as the difference between the baseline and 3-month examination.
Measured: 3 months
Secondary outcomes (8)
Change in rheumatoid factor (RF)
change in RF levels (UI/mL) measured as the difference between the baseline and 3-month examination.
Measured: 3 months
Change in anti-citrullinated protein antibodies (ACPAs)
change in ACPA levels (UI/mL) measured as the difference between the baseline and 3-month examination
Measured: 3 months
Change in periodontal attachment level (PAL)
change in PAL (mm) measured as the difference between the baseline and 3-month examination
Measured: 3 months
Change in probing depth (PD)
change in PD (mm) measured as the difference between the baseline and 3-month examination
Measured: 3 months
Change in bleeding on probing (BOP)
change in BOP (%) measured as the difference between the baseline and 3-month examination
Measured: 3 months
Change in microbial counts
change in subgingival microbial counts (% total colony counts) measured as the difference between the baseline and 3-month examination
Measured: 3 months
Change in quality of life
Change in The Short Form ( SF36) Health Survey measured as the difference between the baseline and 3-month examination. It is converted to a 0-100 scale.The lower the score the more disability. The higher the score the less disability.
Measured: 3 months
Change in oral health profile
Change in Oral Health Impact Profile (OHIP-14) measured as the difference between the baseline and 3-month examination. The OHIP-14 scores can range from 0 to 56 and are calculated by summing the ordinal values for the 14 items. Higher scores indicate worse and lower scores indicate better oral health quality of life.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2020
- Study start1 Jan 2019
- Primary completion30 Jun 2021
- Study completion30 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Rheumatoid ArthritisStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad de Antioquia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Javier E Botero, PhD, Principal investigator, Universidad de Antioquia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04658615
- Sponsor's protocol ID
- 05-2016
- Status last verified
- Sep 2021
- First submitted
- 23 Nov 2020
- Last updated
- 29 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Raw data will be available at the end of the study upon request
Publications
Botero JE, Posada-Lopez A, Mejia-Vallejo J, Pineda-Tamayo RA, Bedoya-Giraldo E. Effects of nonsurgical periodontal therapy in patients with rheumatoid arthritis: a prospective before and after study. Colomb Med (Cali). 2021 Sep 30;52(3):e2095051. doi: 10.25100/cm.v52i3.5051. eCollection 2021 Jul-Sep.
PubMed 35431355
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Non-surgical Periodontal Therapy (NSPT) in Patients With and Without Rheumatoid Arthritis (RA)
- ClinicalTrials.gov ID
- NCT04658615
- Acronym / sponsor ID
- 05-2016
- Conditions
- Rheumatoid Arthritis, Periodontitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Universidad de AntioquiaUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 30 Jun 2021 (actual)
- Study completion
- 30 Jun 2021 (actual)
- First posted
- 8 Dec 2020 (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 chronic disease that leads to the loss of teeth. It has been associated to rheumatoid arthritis (RA). Periodontal therapy (NSPT) has been shown to have systemic effects. The objective of this study was to compare the effects of non-surgical periodontal therapy on biochemical parameters of rheumatoid arthritis (RA), periodontal parameters and quality of life in patients with and without RA.
Adult patients with and RA and periodontitis can participate in the study. Participants benefit from the effects of conventional tooth cleaning (periodontal therapy) and oral hygiene instructions. There are no significant risk associated with periodontal therapy.
The study is conducted at the Universidad de Antioquia in Medellin, Colombia. The study is set to start 2019 and end mid 2021. The study is funded by a grant from the Universidad de Antioquia. Contact person: Javier Enrique Botero (javier.botero@udea.edu.co)
Detailed description
After participants are screened for inclusion, serum samples will be collected for the analysis of C-reactive protein (CRP; mg/L), rheumatoid factor (RF; UI/mL) and anti-citrullinated protein antibodies (ACPAs; UI/mL) in a reference laboratory. A complete periodontal chart will be carried out at six sites per tooth excluding third molars by a single experienced clinician using a calibrated probe (Hu-Friedy Mfg. Co.). Subgingival plaque samples will be collected by means of paper points inserted to the bottom of the pocket and processed immediately for culture analysis and detection of Porphyromonas gingivalis. RA patients will be examined by an experienced rheumatologist to determine their Disease Activity Score (DAS-28). All examinations will be taken at baseline and repeated 3 months after intervention.
Non-surgical periodontal therapy (NSPT) will be administered on the following 5 days of inclusion. A single 1-hour session of full-mouth debridement with an ultrasonic device will be carried out in each participant under local anesthesia by an experienced clinician. After NSPT is completed, each patient will receive oral hygiene instructions and oral care pack including toothbrush and toothpaste (toothbrush Vitis Encias Medium; Toothpaste Vitis Encias; Dentaid, Colombia).
Demographic ,clinical history as well as medication data for all participants will be collected. Periodontal parameters of PD (mm), PAL (mm) and BOP (%) will be recorded at each visit. The stage and grade of periodontitis will be established according to the new classification of periodontal diseases (Papapanou et al. 2018). The clinician who records data will not be blinded to the condition of the patients.
Sample size was calculated to detect a 50 % change in CRP with a power of >80% (alpha 0,05) which resulted in 15 per group (Cosgarea et al. 2018). Considering possible dropouts, 20 participants will be included per group. Randomization will not be performed since the purpose was to compare the effects of NSPT in patients with and without RA. The clinical investigator who records periodontal parameters will be calibrated for repeated measurements before patient inclusion (Kappa value was ≥0.80 for PAL and PD). Continuous variables will be presented as the mean and 95% confidence interval (CI) or median [interquartile range] when appropriate. Change in biochemical markers (CRP, RF, ACPAs) and periodontal parameters (PAL, PD, BOP, microbial counts) will be expressed as the delta (∆) from baseline to 3 months after intervention. Differences in means will be determined by the student t test for paired and unpaired samples or non-parametric tests when appropriate. Categorical variables will be presented as frequencies (%) and analyzed in contingency tables and X2. Logistic regression analysis for categorical variables and linear models will be used to test for associations and the odds ratio with 95%CI will be calculated. The primary analysis will be performed as intention to treat and then compared to per-protocol analysis results. The level of statistical significance will be set at 5% (P≤0,05).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group with rheumatoid arthritis | Other | Procedure: Non-surgical periodontal therapyNon-surgical periodontal therapy (NSPT) |
| group without rheumatoid arthritis | Other | Procedure: Non-surgical periodontal therapyNon-surgical periodontal therapy (NSPT) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- age ≥ 18 years old; diagnosis of RA according to the American College of Rheumatology with DAS-28 score ≥ 3.2 and no change in RA medication in the previous 3 months;
- at least 15 teeth excluding third molars;
- ≥2 non-adjacent teeth interproximal sites with loss of periodontal attachment level (PAL) ≥ 2 mm; or buccal or oral PAL ≥3 mm with pocketing >3 mm is detectable at ≥2 teeth.
- Patients without RA met the same criteria except for the diagnosis of RA.
Key exclusion criteria (6 listed)
- periodontal treatment or use of antibiotics in the previous 3 months.
- diabetes, liver disease, head and neck radiation therapy.
- pregnancy
- HIV
- use of cyclosporine.
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 therapyA single 1-hour session of full-mouth debridement with an ultrasonic device under local anesthesia | Procedure or surgery | group with rheumatoid arthritis, group without rheumatoid arthritis |
Primary outcome
Change in C reactive protein
Time frame: 3 months
change in C-reactive protein levels (mg/L) measured as the difference between the baseline and 3-month examination.
8 secondary outcomes
Change in rheumatoid factor (RF)
Time frame: 3 months
Change in anti-citrullinated protein antibodies (ACPAs)
Time frame: 3 months
Change in periodontal attachment level (PAL)
Time frame: 3 months
Change in probing depth (PD)
Time frame: 3 months
Change in bleeding on probing (BOP)
Time frame: 3 months
Change in microbial counts
Time frame: 3 months
Change in quality of life
Time frame: 3 months
Change in oral health profile
Time frame: 3 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 29 Sep 2021.
- Derived from this study: PubMed 35431355Botero JE, Posada-Lopez A, Mejia-Vallejo J, Pineda-Tamayo RA, Bedoya-Giraldo E. Effects of nonsurgical periodontal therapy in patients with rheumatoid arthritis: a prospective before and after study. Colomb Med (Cali). 2021 Sep 30;52(3):e2095051. doi: 10.25100/cm.v52i3.5051. eCollection 2021 Jul-Sep.
- Individual participant dataSharing planned: Yes. Raw data will be available at the end of the study upon request
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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.
Javier E Botero, PhD principal investigator
Universidad de Antioquia
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 therapy in people with Rheumatoid Arthritis and Periodontitis, run by Universidad de Antioquia at 1 site in Colombia.
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 6 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 29 Sep 2021. 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 Colombia. 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?
Change in C reactive protein (time frame: 3 months). 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 NCT04658615, which also lists 1 linked publication.
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 29 Sep 2021.