Condition category
Oral Health
Date applied
17/09/2016
Date assigned
24/11/2016
Last edited
24/11/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and aim:
Several studies suggest a two-way link between rheumatoid arthritis and periodontal (gum) disease. There have been studies that have looked into the effect of non-surgical periodontal therapy on the severity rheumatoid arthritis but the results are contradictory. The bacteria Porphyromonas gingivalis is thought to play an important role in periodontal disease and possibly rheumatoid arthritis. However, this has not been confirmed as there is a lack of evidence. The aim of the study was to compare the effect of non-surgical periodontal treatment on clinical symptoms and severity of inflammation in patients with moderate to severe chronic periodontitis (long term inflammatory gum disease) and rheumatoid arthritis with patients with gum disease but not suffering from rheumatoid arthritis.

Who can participate?
Adults over 30 with moderate or severe chronic periodontitis and with or without rheumatoid arthritis.

What does the study involve from a participants perspective:
All patients from all groups have a dental examination to confirm that they are suffering from chronic periodontitis. They all then receive non-surgical periodontal therapy at all teeth affected by the disease. They also have an oral hygiene assessment, are given instructions to correct brushing technique, have a professional teeth cleaning performed by a doctor, and undergo further cleaning under local anaesthesia of the roots of all affected teeth. Before treatment, at 3 and 6 months after treatments, saliva samples from the gingiva of the 4 most badly affected teeth are taken with paper points and strips. Furthermore, patients suffering of rheumatoid arthritis, undergo a thorough examination of their arthritis, again before treatment, at 3 months and 6 months, which includes the taking of blood samples for assessment.

What are the possible benefits and risks of participating?
All participants benefit from thorough dental examinations. All participants confirmed as having periodontitis, will benefit of non-surgical periodontal treatment. Patients with rheumatoid arthritis will also benefit from a of thorough of their condition. No risks are to be expected.

Where is the study run from?
Clinic for Prosthetic Dentistry, University of Medicine and Pharmacy "IUliu Hatieganu" Cluj-Napoca

When is the study starting and how long is it expected to run for?
Janaury 2012 to August 2015

Who is funding the study?
University of Medicine and Pharmacy Cluj Napoca, Romania

Who is the main contact?
Dr Raluca Cosgarea
ralucacosgarea@gmail.com

Trial website

Contact information

Type

Scientific

Primary contact

Dr Raluca Cosgarea

ORCID ID

http://orcid.org/0000-0003-2148-9645

Contact details

Str. Clinicilor nr. 32
Cluj-Napoca
400503
Romania
0040264 597844
ralucacosgarea@gmail.com

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

#580/13.04.2012

Study information

Scientific title

Effects of non-surgical periodontal therapy on periodontal laboratory and clinical data as well as on disease activity in patients with rheumathoid arthritis

Acronym

RA-PA

Study hypothesis

Non-surgical periodontal treatment improves clinical periodontal, microbiological and inflammatory variables in chronic periodontitis (CP) patients with rheumathoid arthritis (RA) and without RA.

Ethics approval

Ethics Committee (Comisia de etica) of the University of Medicine and Pharmacy "Iuliu Hatieganu", Cluj-Napoca, Romania, 13/04/2012, ref: #580/13.04.2012

Study design

Single-centre prospective non-randomized interventional clinical trial

Primary study design

Interventional

Secondary study design

Non randomised study

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details to request a patient information sheet’

Condition

Chronic periodontitis

Intervention

This study is comparing the effect of non-surgical periodontal treatment on clinical and inflammatory parameters in patients with moderate to severe chronic periodontitis and rheumatoid arthritis with systemically healthy periodontitis patients.

For all patients, at baseline and again at 3 and 6 months after non-surgical periodontal treatment (scaling and root planing SRP), medical and smoking history, clinical periodontal variables (i.e.full mouth plaque score (FMPS), periodontal pocket depth (PD), clinical attachment level (CAL), bleeding on probing (BOP)) were recorded; furthermore, gingival crevicular (GCF) and subgingival plaque were sampled . For RA patients, the following rheumatological parameters were determined at the same timepoints by one specialised rheumatologist: diseases activity score 28 (DAS28), erythrocite sedimentation rate (ESR), C reactive Protein (CRP) and rheumatoid factor (RF).

Oral hygiene instructions and professional prophylaxis sessions were performed until each patient had a FMPS ≤30%. Thereafter, non-surgical periodontal treatment (SRP) was performed within 24 hours by one experienced periodontist as follows: under local anesthesia, all pockets with PD ≥4 mm were scaled and root-planed to the bottom of the pocket with ultrasonic instruments (Kavo Sonicflex Scaler, Kavo Dental GmbH, Biberach, Germany) and Gracey curets (Hu Friedy, Chicago, IL, USA); treated pockets were then thoroughly rinsed with 0.2% chlorhexidine digluconate solution (Corsodyl®, GlaxoSmithKline, Brentford, London, UK) and patients were instructed to rinse twice daily for 2 minutes with a 0.2% chlorhexidine digluconate solution (Corsodyl®, GlaxoSmithKline, Brentford, London, UK) and to brush their teeth with 0.2% chlorhexidine digluconate tooth paste (Elugel®, Pierre Fabre, Paris, France) for 14 days.

Oral hygiene instructions and professional prophylacis sessions:
Dental plaque was colored by means of a dye and the FMPS was assessed. By this dental brushing mistakes were visible to the patients and the correct brushing technique was explained. Furthermore, use of dental floss or interdental brushes was demonstrated and explained. Finally, supragingival plaque and calculus was removed by means of a rubber cup or ultrasonic scaler.

Follow-up: at 3,6 and 12 months patients were recalled for follow-up. At every session the clinical periodontal parameters PD, FMPS, CAL, BOP were assessed, proffessional tooth cleaning was performed, rheumatological parameters CRP, DAS28, ESR and RF were determined. Furthermore, subgingival plaque samples were obtained by means of sterile paper strips and paper points from the 4 deepest pocket depths in the mouth for evaluation of the periodontal bacteria and inflammatory markers.

Intervention type

Phase

Drug names

Primary outcome measures

The decrease of CRP in the patients with rheumatoid arthritis at 3 months (The CRP level, measured as counts, was determined from blood samples in the laboratory of the Clinic of Rheumatology of the University Iuliu Hatieganu Cluj-Napoca).

Secondary outcome measures

1. Changes (from baseline to 6 months) of CRP at 6 months
2. ESR, measured in a similar to the CRP at 3 and 6 months in the RA-CP group
3. DAS28 at 3 and 6 months in the RA-CP group (was calculated using a formula and the ESR value),
4. BOP (calculated as %)
5. FMPS (calculated as %)
6. PD (value measured clinically at teeth in mm)
7. CAL (value measured clinically at teeth in mm)
8. Number of sites PD ≥4 mm incl. their changes (the sites with values of PD≥4mm were counted)
9. Qualitative and quantitative analysis of microorganisms (by means of real-time polymerase chain reaction- is a laboratory test, the are parameters reported as counts of bacteria and number of patients that presented these bacteria)
10. Inflammatory markers in sulcus fluid (these are measured by ELISA Test, a laboratory test, where also the inflammatory markers are reported as counts, and the number of patients the presented the investigated inflammatory markers) at 3 and 6 months for both patient groups

Unless otherwise stated, outcomes were measured at 3 months and 6 months.

Overall trial start date

10/01/2012

Overall trial end date

03/08/2015

Reason abandoned

Eligibility

Participant inclusion criteria

1. Moderate or severe chronic periodontitis; >30 years of age
2. ≥10 natural teeth present in the oral cavity
3. Full-mouth plaque scores (FMPS) ≤30% after oral hygiene instructions
4. No other systemic diseases or medications except for RA, which are known to influence periodontal conditions/treatment outcome (e.g. Down Syndrome, HIV, Diabetes Mellitus type 1 and 2)
5. DAS28≥3.2
6. No infectious or heart diseases that need prophylactic administration of antibiotics before dental treatment
7. No liver disease; no head and neck radiation therapy

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

36 patients

Participant exclusion criteria

1. Non-surgical periodontal therapy within the previous 12 months
2. Systemic or local use of antibiotics within the previous 3 months
3. Medication with a possible influence on the periodontium (e.g., ciclosporines, phenytoines, calcium channel blockers)
4. Pregnancy or lactation

In the RA group, RA was diagnosed according to the criteria set by the American College of Rheumatology;

Recruitment start date

01/05/2012

Recruitment end date

16/12/2014

Locations

Countries of recruitment

Romania

Trial participating centre

Clinic for Prosthetic Dentistry, University of Medicine and Pharmacy "IUliu Hatieganu" Cluj-Napoca
Cluj-Napoca
400506
Romania

Sponsor information

Organisation

University of Medicine and Pharmacy Cluj-Napoca

Sponsor details

Str. Clinicilor nr 32
Cluj-Napoca
400503
Romania

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

University/education

Funder name

University of Medicine and Pharmacy Cluj Napoca, Romania

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Department of Periodontology, University of Bern, Switzerland

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

SCIEX- The scientific exchange program NMS.CH (project number 12.188)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

European Commission (FP7-HEALTH-F3-2012-306029 "TRIGGER")

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Postdoctoral grant POSDRU Grant no. 159/1.5/S/138776 (TRANSCENT)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

It is planned to publish the results in 3 separate papers in a dental medicine journal journal

IPD Sharing plan
The datasets generated and/or analysed during the current study during this study will be included in the subsequent results publication

Intention to publish date

20/09/2017

Participant level data

Other

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes