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Completed

NCT Number: NCT03268473

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

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Key information

Conditions

Periodontitis Apnea Dyssomnias Mouth Diseases Nervous System Diseases OSAS Obstructive Sleep Apnea Periodontal Diseases Respiration Disorders Respiratory Tract Diseases Sleep Apnea Syndromes Sleep Apnea, Obstructive Sleep Disorders, Intrinsic Sleep Wake Disorders Stomatognathic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Bezmialem Vakıf University, Faculty of Dentistry, Deparment of Periodontology,

Istanbul, 34093, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Experimental

Other

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

Control

Other

Control: Non-surgical periodontal therapy in Periodontitis

Primary outcomes

  1. Serum Total Antioxidant Status (TAS) level (millimolar per liter (mmol /L))

    Time frame: 3 months

    Changes in serum and salivary oxidative stress parameters

  2. Serum Total Oxidant Status (TOS) level (mikromolar per liter (µmol /L))

    Time frame: 3 months

    Changes in serum and salivary oxidative stress parameters

  3. Serum Oxidative Stress Index (OSI) level : TOS/TAS

    Time frame: 3 months

    Changes in serum and salivary oxidative stress parameters

  4. Serum Native Thiol (mikromolar per liter (µmol /L))

    Time frame: 3 months

    Changes in serum and salivary oxidative stress parameters

  5. Serum Thiol/disulfid (millimolar per liter (mmol /L))

    Time frame: 3 months

    Changes in serum and salivary oxidative stress parameters

  6. Saliva Total Antioxidant Status (TAS) level (millimolar per liter (mmol /L))

    Time frame: 3 months

    Changes in serum and salivary oxidative stress parameters

  7. Saliva Total Oxidant Status (TOS) level (mikromolar per liter (µmol /L))

    Time frame: 3 months

    Changes in serum and salivary oxidative stress parameters

  8. Saliva Oxidative Stress Index (OSI) level : TOS/TAS

    Time frame: 3 months

    Changes in serum and salivary oxidative stress parameters

  9. Saliva Native Thiol (mikromolar per liter (µmol /L))

    Time frame: 3 months

    Changes in serum and salivary oxidative stress parameters

  10. Saliva Thiol/disulfid (millimolar per liter (mmol /L))

    Time frame: 3 months

    Changes in serum and salivary oxidative stress parameters

Secondary outcomes

  1. Plaque Index (PI)

    Time frame: 3 months

    Change in clinical measures of chronic periodontitis

  2. Gingival Index (GI)

    Time frame: 3 months

    Change in clinical measures of chronic periodontitis

  3. Bleeding on probing (BOP)

    Time frame: 3 months

    Change in clinical measures of chronic periodontitis

  4. Clinical attachment loss(CAL)

    Time frame: 3 months

    Change in clinical measures of chronic periodontitis

  5. Probing pocket depth (PD)

    Time frame: 3 months

    Change in clinical measures of chronic periodontitis

Sponsors and collaborators

Lead sponsor

Bezmialem Vakif University

Other

Registry information

Official study title

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

Acronym: OSAS

Important dates

Study start
2017
Primary completion
2023
Study completion
2023
First posted
Aug 31, 2017
Registry last updated
Feb 28, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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