Relationship between gum disease and rheumatoid arthritis in Vietnamese patients
| ISRCTN | ISRCTN40789708 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN40789708 |
| Secondary identifying numbers | 12135-DHYD |
- Submission date
- 24/06/2020
- Registration date
- 26/06/2020
- Last edited
- 18/08/2020
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Oral Health
Plain English summary of protocol
Background and study aims
Periodontitis is a severe gum infection that can lead to tooth loss and other serious health complications. Rheumatoid arthritis is a long-term condition that causes pain, swelling and stiffness in the joints. The condition usually affects the hands, feet and wrists. Periodontitis (PD) is common in patients with rheumatoid arthritis (RA). The aim of this study is to evaluate the effects of non-surgical periodontal treatment on Vietnamese patients with active RA and periodontitis.
Who can participate?
Adult patients diagnosed with active RA and PD from previous study
What does the study involve?
Patients are divided randomly into two groups: the treatment group and the control group. Both groups are treated with conventional regimens. The control group only will have oral hygiene instruction while the treatment group receive an advanced periodontal treatment intervention, including supragingival scaling and root planning, reviewing the effect after 3 and 6 months, and treating again after each evaluation. Each patient receives an explanation about the treatment procedure for both groups from an investigator. At the end of the study, the control group receive an advanced periodontal treatment intervention. At the end of the study, the control group will receive an advanced periodontal treatment intervention.
What are the possible benefits and risks of participating?
By the end of the study, all patients receive free advanced periodontal treatment (including supragingival scaling and root planning). There are no risks of participating.
Where is the study run from?
Cho Ray Hospital (Viet Nam)
When is the study starting and how long is it expected to run for?
September 2011 to December 2014
Who is funding the study?
Investigator initiated and funded
Who is the main contact?
Nguyen Bich Van
nbvan@ump.edu.vn
Contact information
Scientific
Department of Periodontology, Faculty of Odonto-stomatology
University of Medicine and Pharmacy at Ho Chi Minh City
652 Nguyen Trai
W11, D5
Ho Chi Minh city
749000
Viet Nam
| Phone | +84 28 3855 8735 |
|---|---|
| nbvan@ump.edu.vn |
Study information
| Study design | Single-center interventional randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | Effects of non-surgical periodontal treatment in Vietnamese rheumatoid arthritis patients |
| Study objectives | The researchers aimed to evaluate the effects of non-surgical periodontal treatment on clinical characteristics and serum indices in Vietnamese patients with active RA and periodontitis (PD). |
| Ethics approval(s) | Approved 02/07/2012, Ethics Committee of the University of Medicine and Pharmacy at Ho Chi Minh City (217 Hong Bang Street, W11, D5, Ho Chi Minh City, Viet Nam; +83 8558411; no email provided), ref: No.1781/DHYD-HD |
| Health condition(s) or problem(s) studied | Periodontal disease and rheumatoid arthritis (RA) |
| Intervention | Rheumatoid arthritis is diagnosed according to ACR/EULAR 2010 (American College of Rheumatology/ European League Against Rheumatism). The periodontal condition is detected by a periodontist following the criteria of Machtei, 1992. Both groups are treated with conventional regimens. The assignment of each patient to a study group is determined by means of a randomization technique using sealed and numbered envelopes; details of the sequence were concealed from all clinicians who participated in the study. A staff member not involved in the subsequent experimentation generates a random allocation sequence, in a 1:1 ratio, for distribution of the patients to one of the two groups. The control group only receive oral hygiene instruction while the treatment group receive an advanced periodontal treatment intervention, including supragingival scaling and root planning, reviewing effect after 3 and 6 months respectively, and retreating after each evaluation. The study team consists of a periodontist recording periodontal indices, a rheumatologist assessing swollen and tender joints, and an assistant. Researchers treat periodontitis for RA patients, not involving in periodontal as well as the joint examination. Team members are trained by experts before the study, achieving consistency from 80% to 90.4%. The disease activity score 28 based on CRP (DAS28-CRP), disease activity classification, rheumatoid factor (RF), erythrocyte sedimentation rate (ESR) and reactive Protein - C (CRP) are recorded and monitored at baseline, 3 and 6 months later after undergoing periodontal treatment. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | 1. Periodontal indicators (plaque index (PlI), gingival index (GI), %BOP (percentage of sites with bleeding on probing), probing pocket depth (PPD), and clinical attachment loss (CAL)) measured at six positions in all teeth at baseline, 3 and 6 months 2. Pain measured using the visual analogue score (VAS) at baseline, 3 and 6 months 3. Pain and swelling of 28 joints assessed using DAS28-CRP activity score at baseline, 3 and 6 months |
| Secondary outcome measures | Serum concentrations of rheumatoid factor (RF) and CRP measured with a latex particle-enhanced method at baseline, 3 and 6 months |
| Overall study start date | 01/09/2011 |
| Completion date | 01/12/2014 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 82 |
| Total final enrolment | 82 |
| Key inclusion criteria | 1. Adult patients diagnosed with active RA and PD from previous cross-sectional descriptive study 1.1. Rheumatoid arthritis was diagnosed according to ACR/EULAR 2010 1.2. The periodontal condition was detected by a periodontist following the criteria of Machtei, 1992 |
| Key exclusion criteria | 1. Patients less than 30 years old 2. RAs with other polyarthritides such as polymyalgia, gout, pseudogout, spinal stiffness, Sjögren's syndrome, diabetes mellitus, malignant disease. 3. Less than four real teeth (regardless of the third-largest molars) 4. Received periodontal treatment in the last 3 months 5. Pregnancy, breastfeeding |
| Date of first enrolment | 01/10/2012 |
| Date of final enrolment | 31/08/2013 |
Locations
Countries of recruitment
- Viet Nam
Study participating centre
201B Nguyen Chi Thanh
Ward 12, District 5
Ho Chi Minh City
700000
Viet Nam
Sponsor information
University/education
217 Hong Bang
Ward 11
District 5
Ho Chi Minh city
749000
Viet Nam
| Phone | +84 28 3855 8411 |
|---|---|
| daihocyduoc@ump.edu.vn | |
| Website | https://ump.edu.vn |
"ROR" |
https://ror.org/025kb2624 |
Funders
Funder type
Other
No information available
Results and Publications
| Intention to publish date | 30/07/2020 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | The protocol and study data are being prepared for publication. Planned publication in a high-impact peer-reviewed journal. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are/will be available upon request from Van Bich Nguyen (nbvan@ump.edu.vn). Type of data: raw outcomes of the interventions. When: after publication. Data will be shared with other research groups belong to a university or institute (not for individuals) with reasonable requests (for study purpose only). Means: direct email. No patient information will be shared (by ethical or legal restrictions). |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/10/2020 | 18/08/2020 | Yes | No |
Editorial Notes
18/08/2020: Internal review.
24/06/2020: Trial's existence confirmed by Ethics Committee of the University of Medicine and Pharmacy at Ho Chi Minh City.
