Study to evaluate the clinical effect of chondroitin sulfate as adjunctive therapy in periodontitis disease
| ISRCTN | ISRCTN15683590 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN15683590 |
| Secondary identifying numbers | MON-CON-2009-01 |
- Submission date
- 01/12/2014
- Registration date
- 22/01/2015
- Last edited
- 22/01/2015
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Oral Health
Plain English summary of protocol
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
Contact information
Scientific
Passeig Marítim de la Barceloneta, 25-29
Barcelona
08003
Spain
Study information
| Study design | Pilot, open-label, observational, prospective study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Longitudinal study |
| Study setting(s) | GP practice |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Pilot, open-label, observational, prospective study to evaluated the clinical effect of chondroitin sulfate adjunctive therapy in patients with periodontitis |
| Study objectives | 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(s) | IMAS-Hospital del Mar, 21/07/2009, ref. (2009/3610/I |
| Health condition(s) or problem(s) studied | 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 |
| 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 study start date | 01/12/2009 |
| Completion date | 30/09/2012 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 20 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 10/03/2010 |
| Date of final enrolment | 30/06/2012 |
Locations
Countries of recruitment
- Spain
Study participating centre
Barcelona
08003
Spain
Barcelona
08003
Spain
Sponsor information
Hospital/treatment centre
Passeig Marítim de la Barceloneta, 25-29
Barcelona
08003
Spain
"ROR" |
https://ror.org/03a8gac78 |
|---|
Funders
Funder type
Hospital/treatment centre
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | To be confirmed at a later date |
| IPD sharing plan |
