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

February 27, 2024 updated by: Bezmialem Vakif University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Istanbul, Turkey, 34093
        • Bezmialem Vakıf University, Faculty of Dentistry, Deparment of Periodontology,

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
Other: Experimental
Experimental: Non-surgical periodontal therapy in patient with OSAS and Periodontitis
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
Other: Control
Control: Non-surgical periodontal therapy in Periodontitis

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bezmialem Vakif University

Investigators

  • Study Chair: Zeliha Betul Özsağır, Bezmialem VU

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2017

Primary Completion (Actual)

August 1, 2023

Study Completion (Actual)

November 1, 2023

Study Registration Dates

First Submitted

August 22, 2017

First Submitted That Met QC Criteria

August 30, 2017

First Posted (Actual)

August 31, 2017

Study Record Updates

Last Update Posted (Estimated)

February 28, 2024

Last Update Submitted That Met QC Criteria

February 27, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • boz001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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