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

Not Applicable

Completed

• Conditions: Periodontitis; OSAS; Obstructive Sleep Apnea
• Interventions: Other: Experimental; Other: Control

• Registration Number: NCT03268473
• Lead Sponsor: Bezmialem Vakif University

Brief Summary

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.

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.

Study Timeline

• Study Start: 2017-07-01
• Study First Submitted: 2017-08-22
• Study First Submitted QC: 2017-08-30
• Study First Posted: 2017-08-31
• Primary Completion: 2023-08-01
• Study Completion: 2023-11-01
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-27
• Last Update Posted: 2024-02-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental: Non-surgical periodontal therapy in patient with OSAS and Periodontitis	Experimental	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
Control: non-surgical periodontal therapy in Periodontitis	Control	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

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Bezmialem Vakıf University, Faculty of Dentistry, Deparment of Periodontology,; 🇹🇷 Istanbul, Turkey