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

Study Overview
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Brief Summary
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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.

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

Conditions
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Osteoporosis, Periodontitis

Intervention / Treatment
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* Procedure: non-surgical periodontal treatment


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 25 patients with periodontitis (P) and osteoporosis (group 1), 25 systemically healthy patients with P (group 2) and 25 systemically and periodontally healthy individuals (group 3) were enrolled in this study. Individuals were periodontally examined at baseline, 1 month and 3 months following the non-surgical periodontal therapy. Participants in group 1 and 2 received non-surgical periodontal therapy including supra- and subgingival scaling, and root planning.Patients were advised and instructed to perform oral care twice a day, use interdental toothbrushes once a day regularly. No scaling and root planning was performed in the group 3.
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
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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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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non-surgical periodontal treatment, bisphosphonates, interleukin-1β, interleukin-17, 8-hydroxydeoxyguanosine, alkaline phosphatase