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

Osteoporosis Clinical Trial

Official title:

EVALUATION OF THE EFFETCS OF NON-SURGICAL PERIODONTAL TREATMENT ON SALIVARY BIOMARKERS OF PATIENTS UNDERGOING BISPHOSPHONATE THERAPY

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04299477
• Other study ID #: 2018/26120
• Status: Completed
• Phase: N/A
• Start date: June 30, 2018
• Est. completion date: May 30, 2019

Study information

• Verified date: March 2020
• Source: Gazi University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: May 30, 2019
• Est. primary completion date: March 30, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 35 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Osteoporosis
• Periodontitis

Intervention

Procedure:
• non-surgical periodontal treatment
supra- and subgingival scaling, and root planning

Locations

Country	Name	City	State
Turkey	Gazi University	Ankara	Cankaya

Sponsors (1)

Lead Sponsor	Collaborator
Gazi University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	salivary levels of IL-1ß at baseline	evaluation of the salivary levels of IL-1ß in g/ml	baseline
Primary	salivary levels of IL-1ß at 1-month	evaluation of the salivary levels of IL-1ß in g/ml	1-month follow-up after non-surgical periodontal therapy
Primary	salivary levels of IL-1ß at 3-month	evaluation of the salivary levels of IL-1ß in g/ml	3-month follow-up after non-surgical periodontal therapy
Primary	salivary levels of IL-17 baseline	evaluation of the salivary levels of IL-17 in g/ml	baseline
Primary	salivary levels of IL-17 at 1-month	evaluation of the salivary levels of IL-17 in g/ml	1-month follow-up after non-surgical periodontal therapy
Primary	salivary levels of IL-17 at 3-month	evaluation of the salivary levels of IL-17 in g/ml	3-month follow-up after non-surgical periodontal therapy
Primary	salivary levels of alkaline phosphatase at baseline	evaluation of the salivary levels of alkaline phosphatase in g/ml	baseline
Primary	salivary levels of alkaline phosphatase at 1-month	evaluation of the salivary levels of alkaline phosphatase in g/ml	1-month follow-up after non-surgical periodontal therapy
Primary	salivary levels of alkaline phosphatase at 3-month	evaluation of the salivary levels of alkaline phosphatase in g/ml	3-month follow-up after non-surgical periodontal therapy
Primary	salivary levels of 8-hydroxydeoxyguanosine at baseline	evaluation of the salivary levels of 8-hydroxydeoxyguanosine in g/ml	baseline
Primary	salivary levels of 8-hydroxydeoxyguanosine at 1-month	evaluation of the salivary levels of 8-hydroxydeoxyguanosine in g/ml	1-month follow-up after non-surgical periodontal therapy
Primary	salivary levels of 8-hydroxydeoxyguanosine at 3-month	evaluation of the salivary levels of 8-hydroxydeoxyguanosine in g/ml	3-month follow-up after non-surgical periodontal therapy
Secondary	Plaque index	Plaque index scores assessed at baseline and at 1 month and 3 months after non-surgical periodontal therapy	baseline, 1- and 3-month follow- up.
Secondary	gingival index	gingival index scores assessed at baseline and at 1 month and 3 months after non-surgical periodontal therapy	baseline, 1- and 3-month follow- up.
Secondary	bleeding on probing	bleeding on probing scores assessed at baseline and at 1 month and 3 months after non-surgical periodontal therapy	baseline, 1- and 3-month follow- up.
Secondary	probing depth	probing depth scores assessed at baseline and at 1 month and 3 months after non-surgical periodontal therapy	baseline, 1- and 3-month follow- up.
Secondary	clinical attachment level	clinical attachment level scores assessed at baseline and at 1 month and 3 months after non-surgical periodontal therapy	baseline, 1- and 3-month follow- up.