Condition category
Oral Health
Date applied
24/06/2020
Date assigned
26/06/2020
Last edited
18/08/2020
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting
Publication status
Results

Plain English Summary

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

Trial website

Contact information

Type

Scientific

Primary contact

Dr Van Nguyen

ORCID ID

Contact details

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
+84 28 3855 8735
nbvan@ump.edu.vn

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

12135-DHYD

Study information

Scientific title

Effects of non-surgical periodontal treatment in Vietnamese rheumatoid arthritis patients

Acronym

Study hypothesis

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

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

Study design

Single-center interventional randomized controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet

Condition

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

Phase

Drug names

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 trial start date

01/09/2011

Overall trial end date

01/12/2014

Reason abandoned (if study stopped)

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

82

Total final enrolment

82

Participant 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

Recruitment start date

01/10/2012

Recruitment end date

31/08/2013

Locations

Countries of recruitment

Viet Nam

Trial 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

Organisation

Ho Chi Minh City Medicine and Pharmacy University

Sponsor details

217 Hong Bang
Ward 11
District 5
Ho Chi Minh city
749000
Viet Nam
+84 28 3855 8411
daihocyduoc@ump.edu.vn

Sponsor type

University/education

Website

https://ump.edu.vn

Funders

Funder type

Other

Funder name

Investigator initiated and funded

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

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 statement
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).

Intention to publish date

30/07/2020

Participant level data

Available on request

Basic results (scientific)

Publication list

2020 results in https://pubmed.ncbi.nlm.nih.gov/32238080/ (added 18/08/2020)

Publication citations

Additional files

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.