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

Overview

The main objective of this study is to compare the effect of the non-surgical periodontal treatment on serum and saliva oxidative stress parameters in patients with periodontitis and obstructive sleep apnea syndrome (OSAS) and in patients with periodontitis only.

Full Title of Study: “Effect of Non-surgical Periodontal Treatment on Oxidative Stress and Antioxidant Status in Obstructive Sleep Apnea Syndrome (OSAS)”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Investigator, Outcomes Assessor)
  • Study Primary Completion Date: August 1, 2023

Detailed Description

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 oxidative stress markers. The investigators aimed to investigate whether non-surgical periodontal treatment on serum and saliva oxidative stress parameters in patients with periodontitis and obstructive sleep apnea syndrome (OSAS) and in patients with periodontitis only.

Interventions

  • Other: Experimental
    • Experimental: Non-surgical periodontal therapy in patient with OSAS and Periodontitis
  • Other: Control
    • Control: Non-surgical periodontal therapy in Periodontitis

Arms, Groups and Cohorts

  • Experimental: Experimental: Non-surgical periodontal therapy in patient with OSAS and Periodontitis
    • Non-surgical periodontal therapy consisted of scaling and root planing and supportive periodontal therapy during 3 months Individuals: with both OSAS and periodontitis Intervention: Procedure: Non-surgical periodontal therapy
  • Active Comparator: Control: non-surgical periodontal therapy in Periodontitis
    • Non-surgical periodontal therapy consisted of scaling and root planing and supportive periodontal therapy during 3 months Individuals: only periodontitis Intervention: Procedure: Non-surgical periodontal therapy

Clinical Trial Outcome Measures

Primary Measures

  • Serum Total Antioxidant Status (TAS) level (millimolar per liter (mmol /L))
    • Time Frame: 3 months
    • Changes in serum and salivary oxidative stress parameters
  • Serum Total Oxidant Status (TOS) level (mikromolar per liter (µmol /L))
    • Time Frame: 3 months
    • Changes in serum and salivary oxidative stress parameters
  • Serum Oxidative Stress Index (OSI) level : TOS/TAS
    • Time Frame: 3 months
    • Changes in serum and salivary oxidative stress parameters
  • Serum Native Thiol (mikromolar per liter (µmol /L))
    • Time Frame: 3 months
    • Changes in serum and salivary oxidative stress parameters
  • Serum Thiol/disulfid (millimolar per liter (mmol /L))
    • Time Frame: 3 months
    • Changes in serum and salivary oxidative stress parameters
  • Saliva Total Antioxidant Status (TAS) level (millimolar per liter (mmol /L))
    • Time Frame: 3 months
    • Changes in serum and salivary oxidative stress parameters
  • Saliva Total Oxidant Status (TOS) level (mikromolar per liter (µmol /L))
    • Time Frame: 3 months
    • Changes in serum and salivary oxidative stress parameters
  • Saliva Oxidative Stress Index (OSI) level : TOS/TAS
    • Time Frame: 3 months
    • Changes in serum and salivary oxidative stress parameters
  • Saliva Native Thiol (mikromolar per liter (µmol /L))
    • Time Frame: 3 months
    • Changes in serum and salivary oxidative stress parameters
  • Saliva Thiol/disulfid (millimolar per liter (mmol /L))
    • Time Frame: 3 months
    • Changes in serum and salivary oxidative stress parameters

Secondary Measures

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

Participating in This Clinical Trial

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)

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Bezmialem Vakif University
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Zeliha Betul Özsağır, Study Chair, Bezmialem VU

References

Loke W, Girvan T, Ingmundson P, Verrett R, Schoolfield J, Mealey BL. Investigating the association between obstructive sleep apnea and periodontitis. J Periodontol. 2015 Feb;86(2):232-43. doi: 10.1902/jop.2014.140229. Epub 2014 Oct 9.

Citations Reporting on Results

Gamsiz-Isik H, Kiyan E, Bingol Z, Baser U, Ademoglu E, Yalcin F. Does Obstructive Sleep Apnea Increase the Risk for Periodontal Disease? A Case-Control Study. J Periodontol. 2017 May;88(5):443-449. doi: 10.1902/jop.2016.160365. Epub 2016 Nov 18.

DPTT study group; Engebretson S, Gelato M, Hyman L, Michalowicz BS, Schoenfeld E. Design features of the Diabetes and Periodontal Therapy Trial (DPTT): a multicenter randomized single-masked clinical trial testing the effect of nonsurgical periodontal therapy on glycosylated hemoglobin (HbA1c) levels in subjects with type 2 diabetes and chronic periodontitis. Contemp Clin Trials. 2013 Nov;36(2):515-26. doi: 10.1016/j.cct.2013.09.010. Epub 2013 Sep 27.

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