CClinicalTrials.gg
Sign In
CompletedNCT03268473OSASUpdated Feb 28, 2024

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

An interventional study of Experimental and Control in Periodontitis, Obstructive Sleep Apnea and OSAS, sponsored by Bezmialem Vakif University. Completed at 1 site in Turkey. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-02-28.

Sponsored by Bezmialem Vakif University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Periodontitis
  • Obstructive Sleep Apnea
  • OSAS

Keywords

  • OSAS
  • Obstructive Sleep Apnea
  • Periodontitis
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • aged ≥18 years old
  • having more than 16 teeth
  • BMI>25 kg/m2

Exclusion criteria

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)
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Investigator, Outcomes assessor)
Enrollment
40 participants (actual)

Study arms

  • 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

  • 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

Interventions

  • OtherExperimental

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

  • OtherControl

    Control: Non-surgical periodontal therapy in Periodontitis

05

What researchers measure

Primary outcomes

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

    Changes in serum and salivary oxidative stress parameters

    Time frame: 3 months

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

    Changes in serum and salivary oxidative stress parameters

    Time frame: 3 months

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

    Changes in serum and salivary oxidative stress parameters

    Time frame: 3 months

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

    Changes in serum and salivary oxidative stress parameters

    Time frame: 3 months

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

    Changes in serum and salivary oxidative stress parameters

    Time frame: 3 months

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

    Changes in serum and salivary oxidative stress parameters

    Time frame: 3 months

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

    Changes in serum and salivary oxidative stress parameters

    Time frame: 3 months

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

    Changes in serum and salivary oxidative stress parameters

    Time frame: 3 months

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

    Changes in serum and salivary oxidative stress parameters

    Time frame: 3 months

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

    Changes in serum and salivary oxidative stress parameters

    Time frame: 3 months

Secondary outcomes

  1. Plaque Index (PI)

    Change in clinical measures of chronic periodontitis

    Time frame: 3 months

  2. Gingival Index (GI)

    Change in clinical measures of chronic periodontitis

    Time frame: 3 months

  3. Bleeding on probing (BOP)

    Change in clinical measures of chronic periodontitis

    Time frame: 3 months

  4. Clinical attachment loss(CAL)

    Change in clinical measures of chronic periodontitis

    Time frame: 3 months

  5. Probing pocket depth (PD)

    Change in clinical measures of chronic periodontitis

    Time frame: 3 months

06

Study locations

1 site
  • Bezmialem Vakıf University, Faculty of Dentistry, Deparment of Periodontology,
    Istanbul, 34093, Turkey
07

References and documents

Publications

  • 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. PubMed 25299385 ↗
  • 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. PubMed 27858556 ↗
  • 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. PubMed 24080100 ↗

Individual participant data

Plan to share: No

08

Registry details

Key details

Study ID
NCT03268473
Lead sponsor
Bezmialem Vakif University
Responsible party
Sponsor
First posted
Aug 31, 2017
Start date
Jul 1, 2017
Primary completion
Aug 1, 2023
Completion
Nov 1, 2023
Last update
Feb 28, 2024

Study contacts

Zeliha Betul Özsağır
study chair · Bezmialem VU

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2024. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Periodontitis→

Other studies from this sponsor

Bezmialem Vakif University

Start the discussion