Plain English Summary
Background and study aims
Periodontitis (PD) is a very common chronic gum infection that damages the soft tissue and destroys the bone supporting the teeth. It can lead to tooth loss, difficulties chewing, poor appearance of teeth and gums and it can even increase the risk of a heart attack or stroke. It is caused by the build-up of bacteria in the mouth (oral bacteria) which, over time, combines with saliva and small food particles to form a sticky film over the teeth, called plaque. The bacteria in the plaque can result in gum disease, leading to swollen, painful gums. If not treated, this gum disease will get worse and will develop into periodontitis. There is no specific pharmacological (drug) treatment for PD and treatment mainly involves good oral hygiene and removing the plaque by scaling and root planning. Here, we want to see if taking chondroitin sulphate (CS), an important chemical found in cartilage, can help treat periodontal disease in patients that also suffer from osteoarthritis (OA). We also want to and to determine salivary biomarker levels of periodontitis.
Who can participate?
PD Patients older than 40, with knee, hand or hip OA taking CS for their OA.
What does the study involve?
All patients in the study are prescribed 800 mg of oral CS once daily. Their periodontitis is assessed at the beginning of the study, and then 3, 6, 9, and 12 months later.
What are the possible benefits and risks of participating?
Possible benefits are related with anti-inflammatory effect of CS on periodontitis. Possible side effects include upset stomach, nausea, heartburn, and diarrhoea.
Where is the study run from?
The Rheumatology service from Hospital del Mar, Barcelona (Spain)
When is study starting and how long is it expected to run for?
December 2009 to September 2012
Who is funding the study?
Rheumatology service from Hospital del Mar, Barcelona (Spain)
Who is the main contact?
1. Dr. Jordi Monfort
jmonfort@parcdesalutmar.cat
2. Dr. Laura Tío
ltio@imim.es
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
MON-CON-2009-01
Study information
Scientific title
Pilot, open-label, observational, prospective study to evaluated the clinical effect of chondroitin sulfate adjunctive therapy in patients with periodontitis
Acronym
Study hypothesis
It is hypothesized that the adjunctive treatment with chondroitin sulfate reduces the clinical signs and symptoms in periodontitis patients. This reduction will be reflected in the levels of salivary biomarkers.
Ethics approval
IMAS-Hospital del Mar, 21/07/2009, ref. (2009/3610/I
Study design
Pilot, open-label, observational, prospective study
Primary study design
Observational
Secondary study design
Longitudinal study
Trial setting
GP practices
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Periodontal disease - a chronic inflammatory process of the periodontal tissue.
Intervention
Osteoarthritic patients were prescribed 800 mg of oral CS once daily (Condrosan®, Bioiberica, S.A., Spain) for this disease, before being eligible to enter the study. Once enrolled were asked not to change their recommended oral hygiene habits or receive additional periodontal treatments throughout the study duration
Intervention type
Supplement
Phase
Drug names
Primary outcome measure
Patients were assessed at baseline 3, 6, 9, and 12 months.
1. Assessment of the periodontal pocket is calculated with CPITN in the more affected dental piece in each sextant of the oral cavity.
2. Gingival inflammation status evaluation Löe and Silness index is recorded from Ramfjord dental pieces (1.6, 2.1,2.4, 3.6, 4.1, 4.4).
In addition, for the establishment of the bone dental support status an orthopantomography (Siemens Ortophos orthopantomograph, PACS software, image scale 1:1) is carried out at baseline, month 6, and end of follow up (month 12). The loss of bone was assessed through the measurement in mm of the distance between the cemento-enamel junction and the bone margin in the 3 most affected teeth.
The pattern of alveolar bone destruction is assessed by a unique expert dentist, by quantifying the vertical defects, which reflex the slow and chronic lesions; and well as horizontal defects, more related to the teeth support and hence in the tooth loss.
Secondary outcome measures
Biomarkers of inflammation (IL-1, IL-18, TNF-alfa, and PGE2) matrix degradation (MMP-8) and bone metabolism markers (osteopontin, OPG and RANKL) are measured in the saliva collected at baseline, 3,6,9 and 12 months. The biomarkers were measured by means of custom made protein microarray except for PGE2 levels that were quantified using an enzyme-linked immunosorbent assay kit.
Overall trial start date
01/12/2009
Overall trial end date
30/09/2012
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Patients > 40 years
2. Fulfilled the American College of Rheumatology classification criteria for clinical knee, hand or hip OA
3. Initiated CS treatment for their OA
4. Had PD of any severity grade as assessed by the Community Periodontal Index Treatment Needs (CPITN)
5. Had PD of grades II, III or IV as assessed with the Löe and Silness gingival index
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
20
Participant exclusion criteria
1. Uncompensated cardiopathy;
2. Impaired renal or liver function;
3. Uncompensated asthma; severe infection
4. Human Immunodeficiency Virus
5. History of alcohol or substance abuse
6. Any currently uncompensated psychiatric disorder
7. Fibromyalgia
8. Uncompensated thyroid disease
9. Having a contraindication to CS use
Recruitment start date
10/03/2010
Recruitment end date
30/06/2012
Locations
Countries of recruitment
Spain
Trial participating centre
Rheumatology Service, Hospital del Mar
Dr. Aiguader 88
Barcelona
08003
Spain
Barcelona
08003
Spain
Funders
Funder type
Hospital/treatment centre
Funder name
Rheumatology Service, Hospital del Mar (Spain)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
To be confirmed at a later date
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list