Rheumatoid ArthritisNCT03513263
Effect of Periodontal Care on Rhematoid Arthritis in Uganda
A study testing Scaling and polishing and oral hygiene instructions in people with Rheumatoid Arthritis and Periodontal Diseases, run by Makerere University at 1 site in Uganda.
Trial summary
this will be an RCT. to determine if non-surgical treatment for periodontitis can improve the disease activity score in 28 joints of rheumatoid arthritis in an African setting. Rheumatoid arthritis patients with periodontal disease will be randomised into an immediate intervention arm and a delayed intervention arm… Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Rheumatoid Arthritis, Periodontal Diseases
- What is being tested?
- Scaling and polishing and oral hygiene instructions
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 152 participants
- Where
- 1 siteUganda
- Study dates
- 1 Sep 2017to 31 Dec 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 years or older (of either gender).
- RA diagnosed at least 2 year before V0.
- DAS28 score between 3.2 and 5.1 during the month preceding V0.
- No change in medication, dose, or formulation in RA treatment during the 3 months preceding V0.
- Available for all study visits over 6 months
- Presence of at least six natural teeth.
- Ability to give written informed consent.
- Having Periodontal Disease
Who cannot join
- Chronic disorder requiring chronic or intermittent use of antibiotics.
- Known hypersensitivity to chlorhexidine digluconate.
- Participation in another intervention study.
- Known contraindications to both amoxicillin and clindamycin.
- Known contraindications to dental local anesthetic.
- Pregnancy or lactation or intent to become pregnant
Trial locations and contacts
1 site in 1 country.
Uganda1 site, 1 recruiting
- Recruiting
Rheumatology clinic, medical outpatient department, Mulago national referral hospital and the Uganda
Kampala
Mark KadduMukasa, PhD, +256 772 633475, mkaddumukasa@chs.mak.ac.ug
About this study
Official title: RCT: Evaluating the Effect of Oral Care for Periodontitis in Rhematoid Arthritis Patients in Uganda
this will be an RCT. to determine if non-surgical treatment for periodontitis can improve the disease activity score in 28 joints of rheumatoid arthritis in an African setting. Rheumatoid arthritis patients with periodontal disease will be randomised into an immediate intervention arm and a delayed intervention arm and both groups will be followed for two three monthly periods
Read the detailed description
- RESEARCH QUESTIONS
- What is the prevalence of periodontitis among rthematoid arthritis patients attending the Mulago rheumatology clinic?
- Does non-surgical treatment for periodontitis improve the disease activity score in 28 joints of rheumatoid arthritis in this local setting?
- Problem statement It has been shown that intervention with nonsurgical treatment of periodontitis improved the periodontal condition of patients with periodontitis and RA, with beneficial effects upon the clinical and laboratory test parameters, disease activity scores in 28 joints (DAS28) and erythrocyte sedimentation rate (ESR). However, all the studies included in the reviews involved small samples sizes and follow-up periods of less than 6 months. And locally to our knowledge there is currently no published information looking at the role of periodontal disease among Ugandans with rheumatoid arthritis.
- METHODS Objective 1 will be addressed with a cross sectional study design while objective 2 will be a randomized control intervention on a fresh sample of patients from the clinic who will be randomly assigned using computer generated random numbers.
Population : To address the objective 1 a total sample size of 146 randomly selected study participants.
For objective 2 the target sample size of 304 individuals or 152 individuals per group.
Procedures: On arrival to the dental clinic, the selected and previously consented participants will undergo a standardized interview. This will be followed by an oral examination to assess for: registration of plaque, bleeding on probing, probing depth and followed with the calculation of the Periodontal inflamed surface area score and clinical attachment loss, pick crevicular fluid using paper point for follow-up confirmatory polymerase chain reactions (PCR), quantification with quantitative real-time PCR (QPCR) experiments for P. gingivalis. At the end of the examination a peripheral blood sample will be obtained for: erythrocyte sedimentation rate to be factored in the determination of DAS 28 score. The remaining blood sample will be stored in the department of Anatomy for further studies latter pertaining to PD and RA.
Objective 2 RCT study Participants will be randomized into an immediate intervention arm and a delayed intervention arm.
- Conditions
- Rheumatoid Arthritis, Periodontal Diseases
- Being tested
- Scaling and polishing, oral hygiene instructions
- Medical subject headings
- Arthritis, Rheumatoid, Periodontal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Scaling and polishingProcedure or surgery
An electronic scaler will be used to clean the gums
oral hygiene instructionsOther
It will include 15-minute oral session with visual and verbal information on how to use a toothbrush, dental floss, and mouthwash correctly; how to clean bridges and dentures; and how and why to use a plaque disclosing test to perform tooth cleaning
| Study group | Role | What they receive |
|---|---|---|
| Scaling and polishing plus oral hygiene instruction | Active comparator | This arm will contain RA participants with PD who will continue with their treatment for RA and also receive the intervention of scaling and polishing plus oral hygiene instructions Receives: Procedure: Scaling and polishing; Other: oral hygiene instructions |
| only oral hygiene instructions | Sham comparator | This arm will contain rheumatoid arthritis (RA) participants with periodontitis who will continue with their treatment for (RA) and also receive only oral hygiene instructions Receives: Other: oral hygiene instructions |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in Disease Activity score of 28 joints
≤ 3.2- inactive, >3.2 but ≤ 5.1 - moderate and > 5.1- very active
Measured: Two three monthly follow ups
Secondary outcomes (1)
change in clinical attachment loss
less than 2mm - improvement, more than 3 mm - getting worse
Measured: Two three monthly follow ups
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2018
- Study start1 Sep 2017
- Primary completion1 Sep 2019 (estimated)
- Study completion31 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- scaling and polishing plus oral hygiene instructions will be provided for the intervention arm while only oral hygiene instruction will be provided for the control arm. At the end of the six month follow up the control arm will also be provided with scaling and polishing.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 152 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Makerere University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ian Munabi, PhD, Study director, MakCHS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03513263
- Sponsor's protocol ID
- SBS 457
- Status last verified
- Mar 2018
- First submitted
- 16 Mar 2018
- Last updated
- 1 May 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RCT: Evaluating the Effect of Oral Care for Periodontitis in Rhematoid Arthritis Patients in Uganda
- ClinicalTrials.gov ID
- NCT03513263
- Acronym / sponsor ID
- SBS 457
- Conditions
- Rheumatoid Arthritis, Periodontal Diseases
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 152 participants (estimated)
- Lead sponsor
- Makerere UniversityUniversity, hospital or other
- Study start
- 1 Sep 2017 (actual)
- Primary completion
- 1 Sep 2019 (estimated)
- Study completion
- 31 Dec 2019 (estimated)
- First posted
- 1 May 2018 (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.
this will be an RCT. to determine if non-surgical treatment for periodontitis can improve the disease activity score in 28 joints of rheumatoid arthritis in an African setting. Rheumatoid arthritis patients with periodontal disease will be randomised into an immediate intervention arm and a delayed intervention arm and both groups will be followed for two three monthly periods
Detailed description
- RESEARCH QUESTIONS
- What is the prevalence of periodontitis among rthematoid arthritis patients attending the Mulago rheumatology clinic?
- Does non-surgical treatment for periodontitis improve the disease activity score in 28 joints of rheumatoid arthritis in this local setting?
- Problem statement It has been shown that intervention with nonsurgical treatment of periodontitis improved the periodontal condition of patients with periodontitis and RA, with beneficial effects upon the clinical and laboratory test parameters, disease activity scores in 28 joints (DAS28) and erythrocyte sedimentation rate (ESR). However, all the studies included in the reviews involved small samples sizes and follow-up periods of less than 6 months. And locally to our knowledge there is currently no published information looking at the role of periodontal disease among Ugandans with rheumatoid arthritis.
- METHODS Objective 1 will be addressed with a cross sectional study design while objective 2 will be a randomized control intervention on a fresh sample of patients from the clinic who will be randomly assigned using computer generated random numbers.
Population : To address the objective 1 a total sample size of 146 randomly selected study participants.
For objective 2 the target sample size of 304 individuals or 152 individuals per group.
Procedures: On arrival to the dental clinic, the selected and previously consented participants will undergo a standardized interview. This will be followed by an oral examination to assess for: registration of plaque, bleeding on probing, probing depth and followed with the calculation of the Periodontal inflamed surface area score and clinical attachment loss, pick crevicular fluid using paper point for follow-up confirmatory polymerase chain reactions (PCR), quantification with quantitative real-time PCR (QPCR) experiments for P. gingivalis. At the end of the examination a peripheral blood sample will be obtained for: erythrocyte sedimentation rate to be factored in the determination of DAS 28 score. The remaining blood sample will be stored in the department of Anatomy for further studies latter pertaining to PD and RA.
Objective 2 RCT study Participants will be randomized into an immediate intervention arm and a delayed intervention arm.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- scaling and polishing plus oral hygiene instructions will be provided for the intervention arm while only oral hygiene instruction will be provided for the control arm. At the end of the six month follow up the control arm will also be provided with scaling and polishing.
| Arm | Type | Receives |
|---|---|---|
| Scaling and polishing plus oral hygiene instruction | Active comparator | Procedure: Scaling and polishing, Other: oral hygiene instructionsThis arm will contain RA participants with PD who will continue with their treatment for RA and also receive the intervention of scaling and polishing plus oral hygiene instructions |
| only oral hygiene instructions | Sham comparator | Other: oral hygiene instructionsThis arm will contain rheumatoid arthritis (RA) participants with periodontitis who will continue with their treatment for (RA) and also receive only oral hygiene instructions |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age 18 years or older (of either gender).
- RA diagnosed at least 2 year before V0.
- DAS28 score between 3.2 and 5.1 during the month preceding V0.
- No change in medication, dose, or formulation in RA treatment during the 3 months preceding V0.
- Available for all study visits over 6 months
Key exclusion criteria (6 listed)
- Chronic disorder requiring chronic or intermittent use of antibiotics.
- Known hypersensitivity to chlorhexidine digluconate.
- Participation in another intervention study.
- Known contraindications to both amoxicillin and clindamycin.
- Known contraindications to dental local anesthetic.
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 |
|---|---|---|
| Scaling and polishingAn electronic scaler will be used to clean the gums | Procedure or surgery | Scaling and polishing plus oral hygiene instruction |
| oral hygiene instructionsIt will include 15-minute oral session with visual and verbal information on how to use a toothbrush, dental floss, and mouthwash correctly; how to clean bridges and dentures; and how and why to use a plaque disclosing test to perform tooth cleaning | Other | Scaling and polishing plus oral hygiene instruction, only oral hygiene instructions |
Primary outcome
change in Disease Activity score of 28 joints
Time frame: Two three monthly follow ups
≤ 3.2- inactive, >3.2 but ≤ 5.1 - moderate and > 5.1- very active
1 secondary outcome
change in clinical attachment loss
Time frame: Two three monthly follow ups
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2018.
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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.
Ian Munabi, PhD study director
MakCHS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Scaling and polishing and oral hygiene instructions in people with Rheumatoid Arthritis and Periodontal Diseases, run by Makerere University at 1 site in Uganda.
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 8 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: status not confirmed, as of the sponsor's last update on 1 May 2018. 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 Uganda. 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. Some participants in this study may receive a placebo. 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 William Buwembo, PhD (+256 751 414863, wbuwembo@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in Disease Activity score of 28 joints (time frame: Two three monthly follow ups). 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 1 May 2018.