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
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

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

Dr Van Nguyen
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
Email nbvan@ump.edu.vn

Study information

Study designSingle-center interventional randomized controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please use contact details to request a participant information sheet
Scientific titleEffects of non-surgical periodontal treatment in Vietnamese rheumatoid arthritis patients
Study objectivesThe 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) studiedPeriodontal disease and rheumatoid arthritis (RA)
InterventionRheumatoid 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 typeProcedure/Surgery
Primary outcome measure1. 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 measuresSerum concentrations of rheumatoid factor (RF) and CRP measured with a latex particle-enhanced method at baseline, 3 and 6 months
Overall study start date01/09/2011
Completion date01/12/2014

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participants82
Total final enrolment82
Key inclusion criteria1. 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 criteria1. 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 enrolment01/10/2012
Date of final enrolment31/08/2013

Locations

Countries of recruitment

  • Viet Nam

Study participating centre

Cho Ray Hospital
Department of Rheumatology
201B Nguyen Chi Thanh
Ward 12, District 5
Ho Chi Minh City
700000
Viet Nam

Sponsor information

Ho Chi Minh City Medicine and Pharmacy University
University/education

217 Hong Bang
Ward 11
District 5
Ho Chi Minh city
749000
Viet Nam

Phone +84 28 3855 8411
Email daihocyduoc@ump.edu.vn
Website https://ump.edu.vn
ROR logo "ROR" https://ror.org/025kb2624

Funders

Funder type

Other

Investigator initiated and funded

No information available

Results and Publications

Intention to publish date30/07/2020
Individual participant data (IPD) Intention to shareYes
IPD sharing plan summaryAvailable on request
Publication and dissemination planThe protocol and study data are being prepared for publication. Planned publication in a high-impact peer-reviewed journal.
IPD sharing planThe 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.