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

Obstructive Sleep Apnea Clinical Trial

— OSAS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03268473
• Other study ID #: boz001
• Status: Completed
• Phase: N/A
• Start date: July 1, 2017
• Est. completion date: November 1, 2023

Study information

• Verified date: February 2024
• Source: Bezmialem Vakif University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: November 1, 2023
• Est. primary completion date: August 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Apnea
• Obstructive Sleep Apnea
• OSAS
• Periodontitis
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

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

Locations

Country	Name	City	State
Turkey	Bezmialem Vakif University, Faculty of Dentistry, Deparment of Periodontology,	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Bezmialem Vakif University

Country where clinical trial is conducted

Turkey, 

References & Publications (3)

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 the — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serum Total Antioxidant Status (TAS) level (millimolar per liter (mmol /L))	Changes in serum and salivary oxidative stress parameters	3 months
Primary	Serum Total Oxidant Status (TOS) level (mikromolar per liter (µmol /L))	Changes in serum and salivary oxidative stress parameters	3 months
Primary	Serum Oxidative Stress Index (OSI) level : TOS/TAS	Changes in serum and salivary oxidative stress parameters	3 months
Primary	Serum Native Thiol (mikromolar per liter (µmol /L))	Changes in serum and salivary oxidative stress parameters	3 months
Primary	Serum Thiol/disulfid (millimolar per liter (mmol /L))	Changes in serum and salivary oxidative stress parameters	3 months
Primary	Saliva Total Antioxidant Status (TAS) level (millimolar per liter (mmol /L))	Changes in serum and salivary oxidative stress parameters	3 months
Primary	Saliva Total Oxidant Status (TOS) level (mikromolar per liter (µmol /L))	Changes in serum and salivary oxidative stress parameters	3 months
Primary	Saliva Oxidative Stress Index (OSI) level : TOS/TAS	Changes in serum and salivary oxidative stress parameters	3 months
Primary	Saliva Native Thiol (mikromolar per liter (µmol /L))	Changes in serum and salivary oxidative stress parameters	3 months
Primary	Saliva Thiol/disulfid (millimolar per liter (mmol /L))	Changes in serum and salivary oxidative stress parameters	3 months
Secondary	Plaque Index (PI)	Change in clinical measures of chronic periodontitis	3 months
Secondary	Gingival Index (GI)	Change in clinical measures of chronic periodontitis	3 months
Secondary	Bleeding on probing (BOP)	Change in clinical measures of chronic periodontitis	3 months
Secondary	Clinical attachment loss(CAL)	Change in clinical measures of chronic periodontitis	3 months
Secondary	Probing pocket depth (PD)	Change in clinical measures of chronic periodontitis	3 months