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

NCT03268473 | Completed

• 1 other identifier: boz001
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Periodontitis; Obstructive Sleep Apnea; OSAS

Keywords

OSAS; Obstructive Sleep Apnea; Periodontitis

Outcome Measures

Primary Outcomes (10)

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

  Changes in serum and salivary oxidative stress parameters

  3 months

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

  Changes in serum and salivary oxidative stress parameters

  3 months

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

  Changes in serum and salivary oxidative stress parameters

  3 months

• Serum Native Thiol (mikromolar per liter (µmol /L))

  Changes in serum and salivary oxidative stress parameters

  3 months

• Serum Thiol/disulfid (millimolar per liter (mmol /L))

  Changes in serum and salivary oxidative stress parameters

  3 months

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

  Changes in serum and salivary oxidative stress parameters

  3 months

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

  Changes in serum and salivary oxidative stress parameters

  3 months

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

  Changes in serum and salivary oxidative stress parameters

  3 months

• Saliva Native Thiol (mikromolar per liter (µmol /L))

  Changes in serum and salivary oxidative stress parameters

  3 months

• Saliva Thiol/disulfid (millimolar per liter (mmol /L))

  Changes in serum and salivary oxidative stress parameters

  3 months

Secondary Outcomes (5)

• Plaque Index (PI)

  3 months

• Gingival Index (GI)

  3 months

• Bleeding on probing (BOP)

  3 months

• Clinical attachment loss(CAL)

  3 months

• Probing pocket depth (PD)

  3 months

Study Arms (2)

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

EXPERIMENTAL

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

Control: non-surgical periodontal therapy in Periodontitis

ACTIVE COMPARATOR

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

Experimental OTHER

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

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

Control OTHER

Control: Non-surgical periodontal therapy in Periodontitis

Control: non-surgical periodontal therapy in Periodontitis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Bezmialem Vakif University: lead

Study Sites (1)

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

Istanbul, 34093, Turkey (Türkiye)

Location

Related Publications (3)

• 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.

  PMID: 25299385 BACKGROUND

• 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.

  PMID: 27858556 RESULT

• 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.

  PMID: 24080100 RESULT

MeSH Terms

Conditions

Periodontitis; Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

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

Study Officials

• Zeliha Betul Özsağır

  Bezmialem VU

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: August 22, 2017
• First Posted: August 31, 2017
• Study Start: July 1, 2017
• Primary Completion: August 1, 2023
• Study Completion: November 1, 2023
• Last Updated: February 28, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)