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

NCT ID: NCT03268473

Last Updated: 2024-02-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-07-01

Study Completion Date

2023-11-01

Brief Summary

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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

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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.

Conditions

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Periodontitis Obstructive Sleep Apnea OSAS

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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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

Group Type EXPERIMENTAL

Experimental

Intervention Type OTHER

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

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

Group Type ACTIVE_COMPARATOR

Control

Intervention Type OTHER

Control: Non-surgical periodontal therapy in Periodontitis

Interventions

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Experimental

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

Intervention Type OTHER

Control

Control: Non-surgical periodontal therapy in Periodontitis

Intervention Type OTHER

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bezmialem Vakif University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Zeliha Betul Özsağır

Role: STUDY_CHAIR

Bezmialem VU

Locations

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

Istanbul, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type BACKGROUND
PMID: 25299385 (View on PubMed)

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.

Reference Type RESULT
PMID: 27858556 (View on PubMed)

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.

Reference Type RESULT
PMID: 24080100 (View on PubMed)

Other Identifiers

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boz001

Identifier Type: -

Identifier Source: org_study_id

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