Effect of Non-surgical Periodontal Treatment on Oxidative Stress and Antioxidant Status in OSAS

Study Overview
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Brief Summary
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The main objective of this study is to investigate whether the non-surgical periodontal treatment of patients with periodontitis and obstructive sleep apnea syndrome (OSAS) affects the prognosis of OSAS positively with polysomnographic, serum and saliva parameters.

Detailed Description
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There is evidence supporting that OSAS is an independent risk factor for cardiovascular and cerebrovascular diseases such as hypertension, congestive heart failure, myocardial infarction, cardiac-arrhythmia, and stroke.Gender, age, smoking, obesity and diabetes, which are risk factors for periodontitis,It is also common in OSAS at the same time.In addition to common risk factors, both OSAS and periodontitis have been shown to be associated with increased cystic inflammation.It has been reported that elevated inflammatory markers in OSAS patients may be associated with periodontal inflammation, although the mechanism of OSAS to systemic inflammation has not yet been clarified. The investigators aimed to investigate whether the non-surgical periodontal treatment of patients with periodontitis and obstructive sleep apnea syndrome (OSAS) affects the course of OSAS positively with polysomnographic, serum and saliva parameters.

Official Title
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Effect of Non-surgical Periodontal Treatment on Oxidative Stress and Antioxidant Status in Obstructive Sleep Apnea Syndrome (OSAS)

Conditions
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Periodontitis, Obstructive Sleep Apnea, OSAS

Intervention / Treatment
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* Other: Non-surgical periodontal therapy
* Other: Delayed non-surgical periodontal therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: aged ≥18 years old having more than 16 teeth BMI>25 kg/m2 Exclusion Criteria: patients with a history of diabetes mellitus or respiratory diseases patients who were under any medication that was known to influence periodontal tissues patients with a history of any periodontal treatment in the past 6 months patients with hormonal changes such as pregnancy or lactation; and 5) patients having fixed dentures or removable prothesis OSAS treatment started (using OSAS therapy device or undergoing surgical operation)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: It's an assessor blinded, parallel group, randomized controlled trial aimed at investigate whether the non-surgical periodontal treatment of patients with periodontitis and obstructive sleep apnea syndrome (OSAS) affects the prognosis of OSAS positively with polysomnographic, serum and saliva parameters.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental: Non-surgical periodontal therapy<br>Non-surgical periodontal therapy consisted of scaling and root planing and supportive periodontal therapy during 3 months Intervention: Procedure: Non-surgical periodontal therapy | Other: Non-surgical periodontal therapy<br>* Experimental: Non-surgical periodontal therapy (scaling and root planing) and supportive periodontal therapy<br>|
| Active Comparator: Delayed non-surgical periodontal therapy<br>No periodontal treatment for 3 months | Other: Delayed non-surgical periodontal therapy<br>* Delayed non-surgical periodontal therapy (scaling and root planing) after the 3 month visit<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum Tumour Necrosis Factor alpha (TNF-α) (nanogram per milliliter (ng/mL)) | Changes in inflammatory parameters | 3 months | 
| Serum Interleukin 1 beta (IL-1β) (nanogram per milliliter (ng/mL)) | Changes in inflammatory parameters | 3 months | 
| Serum Interleukin-12 (IL-12) (nanogram per milliliter (ng/mL)) | Changes in inflammatory parameters | 3 months | 
| Serum C reactive protein (CRP) (nanogram per milliliter (ng/mL)) | Changes in inflammatory parameters | 3 months | 
| Saliva Tumour Necrosis Factor alpha (TNF-α) (nanogram per milliliter (ng/mL)) | Changes in inflammatory parameters | 3 months | 
| Saliva C reactive protein (CRP) (nanogram per milliliter (ng/mL)) | Changes in inflammatory parameters | 3 months | 
| Saliva Interleukin 1 beta (IL-1β) (nanogram per milliliter (ng/mL)) | Changes in inflammatory parameters | 3 months | 
| Saliva Interleukin-6 (IL-6) (nanogram per milliliter (ng/mL)) | Changes in inflammatory parameters | 3 months | 
| Saliva Interleukin-12 (IL-12) (nanogram per milliliter (ng/mL)) | Changes in inflammatory parameters | 3 months | 
| Serum Interleukin-6 (IL-6) (nanogram per milliliter (ng/mL)) | Changes in inflammatory parameters | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plaque Index (PI) | Change in clinical measures of chronic periodontitis | 3 months | 
| Gingival Index (GI) | Change in clinical measures of chronic periodontitis | 3 months | 
| Bleeding on probing (BOP) | Change in clinical measures of chronic periodontitis | 3 months | 
| Clinical attachment loss(CAL) | Change in clinical measures of chronic periodontitis | 3 months | 
| Probing pocket depth (PD) | Change in clinical measures of chronic periodontitis | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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OSAS, Obstructive Sleep Apnea, Periodontitis