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Trial registered on ANZCTR


Registration number
ACTRN12612000446864
Ethics application status
Approved
Date submitted
13/04/2012
Date registered
19/04/2012
Date last updated
19/04/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
Effect of periodontal treatment on rheumatoid arthritis
Scientific title
In individuals with both periodontal disease and rheumatoid arthritis does periodontal treatment influence clinical features of rheumatoid arthritis compared with no periodontal treatment?
Secondary ID [1] 280325 0
Nil
Universal Trial Number (UTN)
Nil
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Rheumatoid arthritis 286287 0
Periodontal Disease 286323 0
Condition category
Condition code
Inflammatory and Immune System 286521 286521 0 0
Rheumatoid arthritis
Oral and Gastrointestinal 286570 286570 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
For patients in the treatment group we will undertake a course of conventional periodontal examination and treatment This will include oral hygiene instruction and full mouth cleaning over a 4 week period. These visits (30 minutes weekly for 4 weeks) will involve cleaning around the teeth under local anaesthesia, doing a quarter of the mouth at a time (upper right, upper left, lower left, lower right). Following this, regular periodontal maintenance involving a periodontal assessment, oral hygiene instruction and full mouth cleaning will be carried out 2,4 and 6 months after completion of the initial conservative periodontal treatment.
Intervention code [1] 284680 0
Treatment: Other
Comparator / control treatment
No periodontal treatment.

Those patients assigned to the non-treatment group will receive neither oral hygiene instruction nor periodontal treatment for the duration of the study (7 months). For ethical reasons, all patients in the control/nontreatment group will be offered treatment at the conclusion of the study (7 months from date of initial examination).
Control group
Active

Outcomes
Primary outcome [1] 286952 0
Change in Disease Activity Score (DAS-28)
Timepoint [1] 286952 0
2, 4 and 6 months
Primary outcome [2] 286953 0
Serum CRP
Timepoint [2] 286953 0
2,4 and 6 months
Primary outcome [3] 286954 0
Anti-CCP antibody levels in serum
Timepoint [3] 286954 0
2,4 and 6 months
Secondary outcome [1] 297051 0
Periodontal response to periodontal treatment. This is achieved by a standard periodontal examination which includes measuring the periodontal pockets, clinical attachment levels, gum bleeding, gum colour and collection of a sample of gingival crevicular fluid. Periodontal pockets and clinical attachment levels are determined using a periodontal probe which is a small metallic instrument with millimetre markings on it. The probe is gently inserted into the space between the gum and the tooth and the depth it sinks to is recorded in millimetres. This is a relatively painless procedure and is standard clinical practice. Gum colour and gum bleeding are assessed visually. Collection of gingival crevicular fluid involves placement of a piece of filter paper adjacent to the position of where the gum meets the tooth. It is left in place for 30 seconds to collect the fluid which naturally seeps out of the periodontal pocket into the oral cavity. This is a painless and atraumatic clinical procedure. The levels of inflammatory cytokines (eg IL-1), CRP, citrullinated proteins and anti-CCP antibodies in the collected fluid are then measured in our laboaratory.
Timepoint [1] 297051 0
2, 4 and 6 months

Eligibility
Key inclusion criteria
All participants must have rheumatoid arthritis.

Willingness to participate and return for multiple visits; presence of gingivitis, mild, moderate or advanced chronic periodontitis, partially or fully dentate patients (at least 20 teeth); no evidence of known systemic modifiers of periodontal disease such as: type I and II diabetes mellitus, osteoporosis, disorders of cellular immunity (e.g. AIDS, cyclic neutropenia, or other known specific leukocyte defects which we know predisposes to periodontitis), medications known to influence the periodontal tissues, or any conditions that would contraindicate a periodontal examination (e.g. risk of bacterial endocarditis).

To be included in the RA group, all participants must have rheumatoid arthritis. Patients will need to indicate a willingness to participate and return for multiple visits and be partially or fully dentate patients (at least 20 teeth). Individuals with evidence of sicca symptoms will not be excluded because decreased salivary flow in these individuals is NOT a modifying or predisposing factor for the development or progression of periodontitis. RA patients will need to have low to moderate disease activity (DAS 2.6-5.1)
Minimum age
30 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients who will not give informed consent; aggressive periodontitis, obvious endodontic infections or other sources of oral infection, pregnancy or lactating females; patients with a significant medical history indicating evidence of known systemic modifiers of periodontal disease as described above; patients who have taken prescribed systemic antibiotics in the last 3 months; patients who would need prophylactic antibiotics before any medical/dental procedures; patients who have received previous periodontal therapy. Smokers and individuals taking medications known to impact on gingival health will also be excluded as these individuals may have impaired responses to conservative periodontal therapy

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
1. Patients attending rheumatology clinics will be asked to fill out a questionaire relating to their periodontal health.

2. If patients answer "yes" to any of these questions they will be invited to undergo a periodontal assessment to determine eligibility for entry into the study.

3. If the peridontal assessment indicates the patient has periodontitis they will be invited to particpate fully in the study. At this stage the examiner will be unaware of which group the individual will be assigned to (treatment or no treatment).

4. Subjects will be randomly assigned to a treatment or non-treatment as described below.

5. Allocation Concealment: Sealed opaque envelopes numbered in sequence containing the group allocation (treatmetn or nontreatment) as determined by random number assignment will be used. The operator will have no knowledge before whether the patient will be assigned to a treament or nontreatment group.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Patients will be allocated to a treatment or non-treatment group using a random assignment process generated through www.random.org to allow assignment of participants to the experimental conditions.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Because of the interventional nature of the treatment it will be impossible for the investigator or the subject to be unaware of which group (treatment or nontreatment) they have been assigned to, thus an unblinded study is our only option. The primary outcome measures of rheumatological markers will be blinded since the investigator carrying out these assays will not know whether the samples have come from a treated or untreated subject.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/06/2012
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
90
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 5234 0
5000
Recruitment postcode(s) [2] 5235 0
5005
Recruitment postcode(s) [3] 5236 0
5041

Funding & Sponsors
Funding source category [1] 285097 0
Government body
Name [1] 285097 0
National Health & Medical Research Council of Australia
Country [1] 285097 0
Australia
Primary sponsor type
University
Name
University of Adelaide
Address
North Terrace
Adelaide SA 5005
Country
Australia
Secondary sponsor category [1] 283957 0
University
Name [1] 283957 0
Dental School
University of Adelaide
Address [1] 283957 0
Frome Road
Adelaide SA 5005
Country [1] 283957 0
Australia
Other collaborator category [1] 260736 0
Hospital
Name [1] 260736 0
Royal Adelaide Hospital
Address [1] 260736 0
North Terrace
Adelaide SA 5000
Country [1] 260736 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287112 0
University of Adelaide Research Ethics & Compliance Unit
Ethics committee address [1] 287112 0
Ethics committee country [1] 287112 0
Australia
Date submitted for ethics approval [1] 287112 0
01/06/2011
Approval date [1] 287112 0
28/06/2011
Ethics approval number [1] 287112 0
H-049-2009

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34064 0
Address 34064 0
Country 34064 0
Phone 34064 0
Fax 34064 0
Email 34064 0
Contact person for public queries
Name 17311 0
Mark Bartold
Address 17311 0
Dental School
University of Adelaide
Frome Road
Adelaide SA 5005
Country 17311 0
Australia
Phone 17311 0
+61 8 8303 3435
Fax 17311 0
+61 8 8303 6429
Email 17311 0
mark.bartold@adelaide.edu.au
Contact person for scientific queries
Name 8239 0
Mark Bartold
Address 8239 0
Dental School
University of Adelaide
Frome Road
Adelaide SA 5005
Country 8239 0
Australia
Phone 8239 0
+61 8 8303 3435
Fax 8239 0
+61 8 8303 6429
Email 8239 0
mark.bartold@adelaide.edu.au

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
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