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

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

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.

Study Overview

• Status: Completed
• Conditions: Periodontitis; Osteoporosis
• Intervention / Treatment: Procedure: non-surgical periodontal treatment

• Study Type: Interventional
• Enrollment (Actual): 75
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Cankaya
    • Ankara, Cankaya, Turkey, 06500
      • Gazi University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Patients with periodontitis and osteoporosis; Group 1 : Patients who have periodontitis and osteoporosis prescribed with bisphosphonates	Procedure: non-surgical periodontal treatment; supra- and subgingival scaling, and root planning
Experimental: Systemically healthy patients with periodontitis; Group 2: Patients who have no systemic diseases but diagnosed as periodontitis	Procedure: non-surgical periodontal treatment; supra- and subgingival scaling, and root planning
No Intervention: Systemically and periodontally healthy individuals; Group 3: Healthy controls

What is the study measuring?

Primary Outcome Measures

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

Outcome Measure	Measure Description	Time Frame
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.
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.
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.
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.
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.

Collaborators and Investigators

• Sponsor: Gazi University
• Investigators: Principal Investigator: Basak Karasu, Gazi University

Study record dates

Study Major Dates

• Study Start (Actual): June 30, 2018
• Primary Completion (Actual): March 30, 2019
• Study Completion (Actual): May 30, 2019

Study Registration Dates

• First Submitted: January 22, 2020
• First Submitted That Met QC Criteria: March 5, 2020
• First Posted (Actual): March 6, 2020

Study Record Updates

• Last Update Posted (Actual): March 6, 2020
• Last Update Submitted That Met QC Criteria: March 5, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Keywords: bisphosphonates; alkaline phosphatase; non-surgical periodontal treatment; interleukin-1β; interleukin-17; 8-hydroxydeoxyguanosine
• Additional Relevant MeSH Terms: Metabolic Diseases; Musculoskeletal Diseases; Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Bone Diseases; Bone Diseases, Metabolic; Periodontitis; Osteoporosis
• Other Study ID Numbers: 2018/26120

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No