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

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ClinicalTrials.gov Identifier: NCT03268473
Recruitment Status : Recruiting
First Posted : August 31, 2017
Last Update Posted : July 13, 2018
Sponsor:
Information provided by (Responsible Party):
Bezmialem Vakif University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Periodontitis Obstructive Sleep Apnea OSAS Other: Non-surgical periodontal therapy Other: Delayed non-surgical periodontal therapy Not Applicable

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 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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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 (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Non-surgical Periodontal Treatment on Oxidative Stress and Antioxidant Status in Obstructive Sleep Apnea Syndrome (OSAS)
Actual Study Start Date : July 1, 2017
Estimated Primary Completion Date : November 1, 2018
Estimated Study Completion Date : January 1, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Experimental: Non-surgical periodontal therapy

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
Experimental: Non-surgical periodontal therapy (scaling and root planing) and supportive periodontal therapy

Active Comparator: Delayed non-surgical periodontal therapy
No periodontal treatment for 3 months
Other: Delayed non-surgical periodontal therapy
Delayed non-surgical periodontal therapy (scaling and root planing) after the 3 month visit




Primary Outcome Measures :
  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 (micromolar 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 (micromolar per liter (µmol /L)) [ Time Frame: 3 months ]
    Changes in inflammatory parameters

  5. Serum Thiol/disulfide (millimolar per liter (mmol /L)) [ Time Frame: 3 months ]
    Changes in inflammatory parameters

  6. Serum Tumour Necrosis Factor alpha (TNF-α) (nanogram per milliliter (ng/mL)) [ Time Frame: 3 months ]
    Changes in inflammatory parameters

  7. Serum Interleukin 1 alpha (IL-1α) (nanogram per milliliter (ng/mL)) [ Time Frame: 3 months ]
    Changes in inflammatory parameters

  8. Serum Interleukin 1 beta (IL-1β) (nanogram per milliliter (ng/mL)) [ Time Frame: 3 months ]
    Changes in inflammatory parameters

  9. Serum Interleukin-6 (IL-6) (nanogram per milliliter (ng/mL)) [ Time Frame: 3 months ]
    Changes in inflammatory parameters

  10. Serum Interleukin-12 (IL-12) (nanogram per milliliter (ng/mL)) [ Time Frame: 3 months ]
    Changes in inflammatory parameters

  11. Serum C reactive protein (CRP) (nanogram per milliliter (ng/mL)) [ Time Frame: 3 months ]
    Changes in inflammatory parameters

  12. Saliva Total Antioxidant Status (TAS) level (millimolar per liter (mmol /L)) [ Time Frame: 3 months ]
    Changes in serum and salivary oxidative stress parameters

  13. Saliva Total Oxidant Status (TOS) level (micromolar per liter (µmol /L)) [ Time Frame: 3 months ]
    Changes in serum and salivary oxidative stress parameters

  14. Saliva Oxidative Stress Index (OSI) level : TOS/TAS [ Time Frame: 3 months ]
    Changes in serum and salivary oxidative stress parameters

  15. Saliva Native Thiol (micromolar per liter (µmol /L)) [ Time Frame: 3 months ]
    Changes in inflammatory parameters

  16. Saliva Thiol/disulfide (millimolar per liter (mmol /L)) [ Time Frame: 3 months ]
    Changes in inflammatory parameters

  17. Saliva Tumour Necrosis Factor alpha (TNF-α) (nanogram per milliliter (ng/mL)) [ Time Frame: 3 months ]
    Changes in inflammatory parameters

  18. Saliva Interleukin 1 alpha (IL-1α) (nanogram per milliliter (ng/mL)) [ Time Frame: 3 months ]
    Changes in inflammatory parameters

  19. Saliva C reactive protein (CRP) (nanogram per milliliter (ng/mL)) [ Time Frame: 3 months ]
    Changes in inflammatory parameters

  20. Saliva Interleukin 1 beta (IL-1β) (nanogram per milliliter (ng/mL)) [ Time Frame: 3 months ]
    Changes in inflammatory parameters

  21. Saliva Interleukin-6 (IL-6) (nanogram per milliliter (ng/mL)) [ Time Frame: 3 months ]
    Changes in inflammatory parameters

  22. Saliva Interleukin-12 (IL-12) (nanogram per milliliter (ng/mL)) [ Time Frame: 3 months ]
    Changes in inflammatory parameters


Secondary Outcome Measures :
  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 level (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

  6. Gingival thickness [ Time Frame: 3 months ]
    Change in clinical measures of chronic periodontitis



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03268473


Contacts
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Contact: Zeliha Betul Ozsagir 5076699794 ext +90 betulozsagir@hotmail.com
Contact: Ebru Saglam 5052604617 ext +90 saglam.ebru@yahoo.com

Locations
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Turkey
Bezmialem Vakıf University, Faculty of Dentistry, Deparment of Periodontology, Recruiting
Istanbul, Turkey, 34093
Contact: Zeliha B Ozsagir    5076699794 ext +90    betulozsagir@hotmail.com   
Contact: Ebru Saglam    5052604617 ext +90    saglam.ebru@yahoo.com   
Sponsors and Collaborators
Bezmialem Vakif University
Investigators
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Study Chair: Zeliha Betul Özsağır Bezmialem VU

Publications of Results:
Other Publications:
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Responsible Party: Bezmialem Vakif University
ClinicalTrials.gov Identifier: NCT03268473     History of Changes
Other Study ID Numbers: boz001
First Posted: August 31, 2017    Key Record Dates
Last Update Posted: July 13, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Bezmialem Vakif University:
OSAS
Obstructive Sleep Apnea
Periodontitis
Additional relevant MeSH terms:
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Periodontitis
Apnea
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs