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

Primary Purpose

Periodontitis, Obstructive Sleep Apnea, OSAS

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Non-surgical periodontal therapy
Delayed non-surgical periodontal therapy
Sponsored by
Bezmialem Vakif University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Periodontitis focused on measuring OSAS, Obstructive Sleep Apnea, Periodontitis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Experimental: Non-surgical periodontal therapy

Delayed non-surgical periodontal therapy

Arm Description

Non-surgical periodontal therapy consisted of scaling and root planing and supportive periodontal therapy during 3 months Intervention: Procedure: Non-surgical periodontal therapy

No periodontal treatment for 3 months

Outcomes

Primary Outcome Measures

Serum Tumour Necrosis Factor alpha (TNF-α) (nanogram per milliliter (ng/mL))
Changes in inflammatory parameters
Serum Interleukin 1 beta (IL-1β) (nanogram per milliliter (ng/mL))
Changes in inflammatory parameters
Serum Interleukin-12 (IL-12) (nanogram per milliliter (ng/mL))
Changes in inflammatory parameters
Serum C reactive protein (CRP) (nanogram per milliliter (ng/mL))
Changes in inflammatory parameters
Saliva Tumour Necrosis Factor alpha (TNF-α) (nanogram per milliliter (ng/mL))
Changes in inflammatory parameters
Saliva C reactive protein (CRP) (nanogram per milliliter (ng/mL))
Changes in inflammatory parameters
Saliva Interleukin 1 beta (IL-1β) (nanogram per milliliter (ng/mL))
Changes in inflammatory parameters
Saliva Interleukin-6 (IL-6) (nanogram per milliliter (ng/mL))
Changes in inflammatory parameters
Saliva Interleukin-12 (IL-12) (nanogram per milliliter (ng/mL))
Changes in inflammatory parameters
Serum Interleukin-6 (IL-6) (nanogram per milliliter (ng/mL))
Changes in inflammatory parameters

Secondary Outcome Measures

Plaque Index (PI)
Change in clinical measures of chronic periodontitis
Gingival Index (GI)
Change in clinical measures of chronic periodontitis
Bleeding on probing (BOP)
Change in clinical measures of chronic periodontitis
Clinical attachment loss(CAL)
Change in clinical measures of chronic periodontitis
Probing pocket depth (PD)
Change in clinical measures of chronic periodontitis

Full Information

First Posted
August 22, 2017
Last Updated
November 8, 2021
Sponsor
Bezmialem Vakif University
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1. Study Identification

Unique Protocol Identification Number
NCT03268473
Brief Title
Effect of Non-surgical Periodontal Treatment on Oxidative Stress and Antioxidant Status in OSAS
Acronym
OSAS
Official Title
Effect of Non-surgical Periodontal Treatment on Oxidative Stress and Antioxidant Status in Obstructive Sleep Apnea Syndrome (OSAS)
Study Type
Interventional

2. Study Status

Record Verification Date
November 2021
Overall Recruitment Status
Completed
Study Start Date
July 1, 2017 (Actual)
Primary Completion Date
May 1, 2019 (Actual)
Study Completion Date
August 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bezmialem Vakif University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
The main objective of this study is to investigate whether the non-surgical periodontal treatment of patients with periodontitis and obstructive sleep apnea syndrome (OSAS) affects the prognosis of OSAS positively with polysomnographic, serum and saliva parameters.
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 cystic inflammation.It has been reported that elevated inflammatory markers in OSAS patients may be associated with periodontal inflammation, although the mechanism of OSAS to systemic inflammation has not yet been clarified. The investigators aimed to investigate whether the non-surgical periodontal treatment of patients with periodontitis and obstructive sleep apnea syndrome (OSAS) affects the course of OSAS positively with polysomnographic, serum and saliva parameters.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Periodontitis, Obstructive Sleep Apnea, OSAS
Keywords
OSAS, Obstructive Sleep Apnea, Periodontitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
It's an assessor blinded, parallel group, randomized controlled trial aimed at investigate whether the non-surgical periodontal treatment of patients with periodontitis and obstructive sleep apnea syndrome (OSAS) affects the prognosis of OSAS positively with polysomnographic, serum and saliva parameters.
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental: Non-surgical periodontal therapy
Arm Type
Experimental
Arm Description
Non-surgical periodontal therapy consisted of scaling and root planing and supportive periodontal therapy during 3 months Intervention: Procedure: Non-surgical periodontal therapy
Arm Title
Delayed non-surgical periodontal therapy
Arm Type
Active Comparator
Arm Description
No periodontal treatment for 3 months
Intervention Type
Other
Intervention Name(s)
Non-surgical periodontal therapy
Intervention Description
Experimental: Non-surgical periodontal therapy (scaling and root planing) and supportive periodontal therapy
Intervention Type
Other
Intervention Name(s)
Delayed non-surgical periodontal therapy
Intervention Description
Delayed non-surgical periodontal therapy (scaling and root planing) after the 3 month visit
Primary Outcome Measure Information:
Title
Serum Tumour Necrosis Factor alpha (TNF-α) (nanogram per milliliter (ng/mL))
Description
Changes in inflammatory parameters
Time Frame
3 months
Title
Serum Interleukin 1 beta (IL-1β) (nanogram per milliliter (ng/mL))
Description
Changes in inflammatory parameters
Time Frame
3 months
Title
Serum Interleukin-12 (IL-12) (nanogram per milliliter (ng/mL))
Description
Changes in inflammatory parameters
Time Frame
3 months
Title
Serum C reactive protein (CRP) (nanogram per milliliter (ng/mL))
Description
Changes in inflammatory parameters
Time Frame
3 months
Title
Saliva Tumour Necrosis Factor alpha (TNF-α) (nanogram per milliliter (ng/mL))
Description
Changes in inflammatory parameters
Time Frame
3 months
Title
Saliva C reactive protein (CRP) (nanogram per milliliter (ng/mL))
Description
Changes in inflammatory parameters
Time Frame
3 months
Title
Saliva Interleukin 1 beta (IL-1β) (nanogram per milliliter (ng/mL))
Description
Changes in inflammatory parameters
Time Frame
3 months
Title
Saliva Interleukin-6 (IL-6) (nanogram per milliliter (ng/mL))
Description
Changes in inflammatory parameters
Time Frame
3 months
Title
Saliva Interleukin-12 (IL-12) (nanogram per milliliter (ng/mL))
Description
Changes in inflammatory parameters
Time Frame
3 months
Title
Serum Interleukin-6 (IL-6) (nanogram per milliliter (ng/mL))
Description
Changes in inflammatory parameters
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Plaque Index (PI)
Description
Change in clinical measures of chronic periodontitis
Time Frame
3 months
Title
Gingival Index (GI)
Description
Change in clinical measures of chronic periodontitis
Time Frame
3 months
Title
Bleeding on probing (BOP)
Description
Change in clinical measures of chronic periodontitis
Time Frame
3 months
Title
Clinical attachment loss(CAL)
Description
Change in clinical measures of chronic periodontitis
Time Frame
3 months
Title
Probing pocket depth (PD)
Description
Change in clinical measures of chronic periodontitis
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zeliha Betul Özsağır
Organizational Affiliation
Bezmialem VU
Official's Role
Study Chair
Facility Information:
Facility Name
Bezmialem Vakıf University, Faculty of Dentistry, Deparment of Periodontology,
City
Istanbul
ZIP/Postal Code
34093
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
25299385
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.
Results Reference
background
PubMed Identifier
27858556
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.
Results Reference
result
PubMed Identifier
24080100
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.
Results Reference
result

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

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