Study to evaluate the clinical effect of chondroitin sulfate as adjunctive therapy in periodontitis disease

Completed

Conditions: Periodontal disease - a chronic inflammatory process of the periodontal tissue.
Oral Health
Periodontitis

Registration Number: ISRCTN15683590

Lead Sponsor: Rheumatology Service, Hospital del Mar

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 20

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

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

Study & Design

Study Type: Observational

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Patients were assessed at baseline 3, 6, 9, and 12 months. <br>1. Assessment of the periodontal pocket is calculated with CPITN in the more affected dental piece in each sextant of the oral cavity. <br>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). <br><br>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.<br>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

Name	Time	Method
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.