Non-surgical periodontal therapy in rheumatoid arthritis patients

• Register: ISRCTN
• Last refreshed on: 19 December 2016
• Main ID: ISRCTN60187959
• Date of registration: 24/11/2016
• Prospective Registration: No
• Primary sponsor: University of Medicine and Pharmacy Cluj-Napoca
• Public title: Non-surgical periodontal therapy in rheumatoid arthritis patients
• 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
• Date of first enrolment: 01/05/2012
• Target sample size: 36
• Recruitment status: Completed
• URL: http://isrctn.com/ISRCTN60187959
• Study type: Interventional
• Study design: Single-centre prospective non-randomized interventional clinical trial (Treatment)

Countries of recruitment

Romania

Contacts

• Name: Raluca Cosgarea

Key inclusion & exclusion criteria

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
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;

Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

Chronic periodontitis
Oral Health
Chronic periodontitis

Intervention(s)

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 mis

Primary Outcome(s)

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(s)

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.

Secondary ID(s)

#580/13.04.2012

Source(s) of Monetary Support

University of Medicine and Pharmacy Cluj Napoca, Romania, Department of Periodontology, University of Bern, Switzerland, SCIEX- The scientific exchange program NMS.CH (project number 12.188), European Commission (FP7-HEALTH-F3-2012-306029 "TRIGGER") , Postdoctoral grant POSDRU Grant no. 159/1.5/S/138776 (TRANSCENT)