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

Not Applicable

Completed

• Conditions: Osteoporosis; Periodontitis
• Interventions: Procedure: non-surgical periodontal treatment

• Registration Number: NCT04299477
• Lead Sponsor: Gazi University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-06-30
• Primary Completion: 2019-03-30
• Study Completion: 2019-05-30
• Study First Submitted: 2020-01-22
• Status Verified: 2020-03
• Study First Submitted QC: 2020-03-05
• Last Update Submitted: 2020-03-05
• Study First Posted: 2020-03-06
• Last Update Posted: 2020-03-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 75

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Systemically healthy patients with periodontitis	non-surgical periodontal treatment	Group 2: Patients who have no systemic diseases but diagnosed as periodontitis
Patients with periodontitis and osteoporosis	non-surgical periodontal treatment	Group 1 : Patients who have periodontitis and osteoporosis prescribed with bisphosphonates

Primary Outcome Measures

Name	Time	Method
salivary levels of IL-17 at 1-month	1-month follow-up after non-surgical periodontal therapy	evaluation of the salivary levels of IL-17 in g/ml
salivary levels of 8-hydroxydeoxyguanosine at 3-month	3-month follow-up after non-surgical periodontal therapy	evaluation of the salivary levels of 8-hydroxydeoxyguanosine in g/ml
salivary levels of IL-17 baseline	baseline	evaluation of the salivary levels of IL-17 in g/ml
salivary levels of IL-17 at 3-month	3-month follow-up after non-surgical periodontal therapy	evaluation of the salivary levels of IL-17 in g/ml
salivary levels of alkaline phosphatase at 1-month	1-month follow-up after non-surgical periodontal therapy	evaluation of the salivary levels of alkaline phosphatase in g/ml
salivary levels of 8-hydroxydeoxyguanosine at 1-month	1-month follow-up after non-surgical periodontal therapy	evaluation of the salivary levels of 8-hydroxydeoxyguanosine in g/ml
salivary levels of IL-1β at baseline	baseline	evaluation of the salivary levels of IL-1β in g/ml
salivary levels of IL-1β at 1-month	1-month follow-up after non-surgical periodontal therapy	evaluation of the salivary levels of IL-1β in g/ml
salivary levels of IL-1β at 3-month	3-month follow-up after non-surgical periodontal therapy	evaluation of the salivary levels of IL-1β in g/ml
salivary levels of alkaline phosphatase at baseline	baseline	evaluation of the salivary levels of alkaline phosphatase in g/ml
salivary levels of alkaline phosphatase at 3-month	3-month follow-up after non-surgical periodontal therapy	evaluation of the salivary levels of alkaline phosphatase in g/ml
salivary levels of 8-hydroxydeoxyguanosine at baseline	baseline	evaluation of the salivary levels of 8-hydroxydeoxyguanosine in g/ml

Secondary Outcome Measures

Name	Time	Method
bleeding on probing	baseline, 1- and 3-month follow- up.	bleeding on probing scores assessed at baseline and at 1 month and 3 months after non-surgical periodontal therapy
gingival index	baseline, 1- and 3-month follow- up.	gingival index scores assessed at baseline and at 1 month and 3 months after non-surgical periodontal therapy
clinical attachment level	baseline, 1- and 3-month follow- up.	clinical attachment level scores assessed at baseline and at 1 month and 3 months after non-surgical periodontal therapy
Plaque index	baseline, 1- and 3-month follow- up.	Plaque index scores assessed at baseline and at 1 month and 3 months after non-surgical periodontal therapy
probing depth	baseline, 1- and 3-month follow- up.	probing depth scores assessed at baseline and at 1 month and 3 months after non-surgical periodontal therapy

Trial Locations

Locations (1)

Gazi University; 🇹🇷 Ankara, Cankaya, Turkey