Clinical trial NCT03268473: Effect of Non-surgical Periodontal Treatment on Oxidative Stress and Antioxidant Status in OSAS
Official title: Effect of Non-surgical Periodontal Treatment on Oxidative Stress and Antioxidant Status in Obstructive Sleep Apnea Syndrome (OSAS)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Periodontitis
Obstructive Sleep Apnea
OSAS
Keywords: OSAS
Obstructive Sleep Apnea
Periodontitis
Lead sponsor: Bezmialem Vakif University
Sponsor class: OTHER
First posted: 2017-08-31
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: It's an assessor blinded, parallel group, randomized controlled trial aimed at 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.
Primary purpose: TREATMENT

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.

Eligibility 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)

Primary outcomes:
measure: Serum Total Antioxidant Status (TAS) level (millimolar per liter (mmol /L))
timeFrame: 3 months
measure: Serum Total Oxidant Status (TOS) level (mikromolar per liter (µmol /L))
timeFrame: 3 months
measure: Serum Oxidative Stress Index (OSI) level : TOS/TAS
timeFrame: 3 months
measure: Serum Native Thiol (mikromolar per liter (µmol /L))
timeFrame: 3 months
measure: Serum Thiol/disulfid (millimolar per liter (mmol /L))
timeFrame: 3 months
measure: Saliva Total Antioxidant Status (TAS) level (millimolar per liter (mmol /L))
timeFrame: 3 months
measure: Saliva Total Oxidant Status (TOS) level (mikromolar per liter (µmol /L))
timeFrame: 3 months
measure: Saliva Oxidative Stress Index (OSI) level : TOS/TAS
timeFrame: 3 months
measure: Saliva Native Thiol (mikromolar per liter (µmol /L))
timeFrame: 3 months
measure: Saliva Thiol/disulfid (millimolar per liter (mmol /L))
timeFrame: 3 months
Secondary outcomes:
measure: Plaque Index (PI)
timeFrame: 3 months
measure: Gingival Index (GI)
timeFrame: 3 months
measure: Bleeding on probing (BOP)
timeFrame: 3 months
measure: Clinical attachment loss(CAL)
timeFrame: 3 months
measure: Probing pocket depth (PD)
timeFrame: 3 months
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Bezmialem Vakıf University, Faculty of Dentistry, Deparment of Periodontology,
Study officials:
affiliation: Bezmialem VU
name: Zeliha Betul Özsağır
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: 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.