THE EFFETCS OF NON-SURGICAL PERIODONTAL TREATMENT ON SALIVARY BIOMARKERS OF PATIENTS WITH OSTEOPOROSIS AND PERIODONTITIS

NCT ID: NCT04299477

Last Updated: 2020-03-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 75 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-06-30
• Study Completion Date: 2019-05-30

Brief Summary

Inflammatory mediators in periodontitis may lead to elevated systemic cytokine levels, resulting in increased bone resorption including the jaws. Osteoporosis may have an influence on the periodontal condition of post-menopausal women and the risk for periodontal disease may increase due to osteoporosis. The hypothesis of the study was that non-surgical periodontal treatment and medical treatment of osteoporosis by bisphosphonates may improve the clinical outcomes and decrease salivary levels of IL-1β, IL-17, ALP and 8-OHdG. Therefore, the aim of this study was to evaluate the mechanism of bi-directional relationship between osteoporosis and periodontal diseases and to investigate the outcomes of non-surgical periodontal treatment with regard to salivary levels of IL-1β, IL-17, 8-OHdG and ALP in patients with periodontitis and osteoporosis.

Conditions

Osteoporosis; Periodontitis

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Patients with periodontitis and osteoporosis

Group 1 : Patients who have periodontitis and osteoporosis prescribed with bisphosphonates

Group Type: EXPERIMENTAL

non-surgical periodontal treatment

Intervention Type: PROCEDURE

supra- and subgingival scaling, and root planning

Systemically healthy patients with periodontitis

Group 2: Patients who have no systemic diseases but diagnosed as periodontitis

Group Type: EXPERIMENTAL

non-surgical periodontal treatment

Intervention Type: PROCEDURE

supra- and subgingival scaling, and root planning

Systemically and periodontally healthy individuals

Group 3: Healthy controls

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

non-surgical periodontal treatment

supra- and subgingival scaling, and root planning

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• The participants were postmenopausal patients defined as absence of menstruation for at least 12 months.
• Patients with periodontitis;
• Patients who had no systemic diseases and were periodontally healthy (no attachment loss),
• Patients who were treated with oral bisphosphonate at least one year (70 mg tablet once weekly)

Exclusion Criteria

• if they had received any periodontal treatment in the preceding three months,
• if they were pregnant or in the period of lactation,
• if they had systemic diseases that may interfere with normal healing mechanism,
• if they had taken antibiotics, anticonvulsants, immunosuppressants, calcium channel blockers in the preceding six months.
• Smokers

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Gazi University

OTHER

Sponsor Role: lead

Responsible Party

Basak Karasu

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Basak Karasu

Role: PRINCIPAL_INVESTIGATOR

Gazi University

Locations

Gazi University

Ankara, Cankaya, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

2018/26120

Identifier Type: -

Identifier Source: org_study_id