PeriodontitisOSASNCT03268473

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

A study testing Experimental in people with Periodontitis and Obstructive Sleep Apnea, run by Bezmialem Vakif University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Periodontitis, Obstructive Sleep Apnea, OSAS
What is being tested?: Experimental
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 40 participants
Where: 1 siteTurkey (Türkiye)
Study dates: 1 Jul 2017to 1 Nov 2023
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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)

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

Bezmialem Vakıf University, Faculty of Dentistry, Deparment of Periodontology,
Istanbul, 34093

Other trials in Turkey (Türkiye)

About this study

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

Read the 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.

Conditions: Periodontitis, Obstructive Sleep Apnea, OSAS
Being tested: Experimental, Control
Keywords: OSAS, Obstructive Sleep Apnea, Periodontitis
Medical subject headings: Periodontitis, Sleep Apnea, Obstructive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT03268473
Study group	Role	What they receive
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 Receives: 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 Receives: Other: Control

What is being measured

The primary outcome is the main question the study is designed to answer.

Serum Total Antioxidant Status (TAS) level (millimolar per liter (mmol /L))
Changes in serum and salivary oxidative stress parameters
Measured: 3 months
Serum Total Oxidant Status (TOS) level (mikromolar per liter (µmol /L))
Changes in serum and salivary oxidative stress parameters
Measured: 3 months
Serum Oxidative Stress Index (OSI) level : TOS/TAS
Changes in serum and salivary oxidative stress parameters
Measured: 3 months
Serum Native Thiol (mikromolar per liter (µmol /L))
Changes in serum and salivary oxidative stress parameters
Measured: 3 months
Serum Thiol/disulfid (millimolar per liter (mmol /L))
Changes in serum and salivary oxidative stress parameters
Measured: 3 months
Saliva Total Antioxidant Status (TAS) level (millimolar per liter (mmol /L))
Changes in serum and salivary oxidative stress parameters
Measured: 3 months
Saliva Total Oxidant Status (TOS) level (mikromolar per liter (µmol /L))
Changes in serum and salivary oxidative stress parameters
Measured: 3 months
Saliva Oxidative Stress Index (OSI) level : TOS/TAS
Changes in serum and salivary oxidative stress parameters
Measured: 3 months
Saliva Native Thiol (mikromolar per liter (µmol /L))
Changes in serum and salivary oxidative stress parameters
Measured: 3 months
Saliva Thiol/disulfid (millimolar per liter (mmol /L))
Changes in serum and salivary oxidative stress parameters
Measured: 3 months

Secondary outcomes (5)

Plaque Index (PI)
Change in clinical measures of chronic periodontitis
Measured: 3 months
Gingival Index (GI)
Change in clinical measures of chronic periodontitis
Measured: 3 months
Bleeding on probing (BOP)
Change in clinical measures of chronic periodontitis
Measured: 3 months
Clinical attachment loss(CAL)
Change in clinical measures of chronic periodontitis
Measured: 3 months
Probing pocket depth (PD)
Change in clinical measures of chronic periodontitis
Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Jul 20171 Nov 2023

First posted31 Aug 2017
Study start1 Jul 2017
Primary completion1 Aug 2023
Study completion1 Nov 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (3)Papers the sponsor has linked to this study.
Other trials for PeriodontitisStudies of the same condition, open and under way.
More trials run by Bezmialem Vakif UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
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.
Masking: Double blind
Who is masked: Investigator, Outcomes assessor
Enrolment: 40 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03268473
Sponsor's protocol ID: boz001
Acronym: OSAS
Status last verified: Feb 2024
First submitted: 22 Aug 2017
Last updated: 28 Feb 2024
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

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.
PubMed 25299385
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.
PubMed 27858556
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.
PubMed 24080100

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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A Retrospective Comparative Evaluation of Omega-3 and Resveratrol Supplementation in Patients With Periodontitis
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Effects of Different Activation Techniques on Antimicrobial Photodynamic Therapy in Apical Periodontitis
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All Periodontitis trials

Study at a glance

From the registry record, last updated by the sponsor on 28 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effect of Non-surgical Periodontal Treatment on Oxidative Stress and Antioxidant Status in Obstructive Sleep Apnea Syndrome (OSAS)
ClinicalTrials.gov ID: NCT03268473
Acronym / sponsor ID: OSAS / boz001
Conditions: Periodontitis, Obstructive Sleep Apnea, OSAS
Keywords: OSAS, Obstructive Sleep Apnea, Periodontitis
Study type: Interventional
Recruitment status: Completed
Enrolment: 40 participants (actual)
Lead sponsor: Bezmialem Vakif UniversityUniversity, hospital or other
Study start: 1 Jul 2017 (actual)
Primary completion: 1 Aug 2023 (actual)
Study completion: 1 Nov 2023 (actual)
First posted: 31 Aug 2017 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (investigator, outcomes assessor)
Number of arms: 2
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.

Arm	Type	Receives
Experimental: Non-surgical periodontal therapy in patient with OSAS and Periodontitis	Experimental	Other: ExperimentalNon-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
Control: non-surgical periodontal therapy in Periodontitis	Active comparator	Other: ControlNon-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

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

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

Key exclusion criteria (5 listed)

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)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
ExperimentalExperimental: Non-surgical periodontal therapy in patient with OSAS and Periodontitis	Other	Experimental: Non-surgical periodontal therapy in patient with OSAS and Periodontitis
ControlControl: Non-surgical periodontal therapy in Periodontitis	Other	Control: non-surgical periodontal therapy in Periodontitis

Primary outcome

Serum Total Antioxidant Status (TAS) level (millimolar per liter (mmol /L))
Time frame: 3 months
Changes in serum and salivary oxidative stress parameters
Serum Total Oxidant Status (TOS) level (mikromolar per liter (µmol /L))
Time frame: 3 months
Changes in serum and salivary oxidative stress parameters
Serum Oxidative Stress Index (OSI) level : TOS/TAS
Time frame: 3 months
Changes in serum and salivary oxidative stress parameters
Serum Native Thiol (mikromolar per liter (µmol /L))
Time frame: 3 months
Changes in serum and salivary oxidative stress parameters
Serum Thiol/disulfid (millimolar per liter (mmol /L))
Time frame: 3 months
Changes in serum and salivary oxidative stress parameters
Saliva Total Antioxidant Status (TAS) level (millimolar per liter (mmol /L))
Time frame: 3 months
Changes in serum and salivary oxidative stress parameters
Saliva Total Oxidant Status (TOS) level (mikromolar per liter (µmol /L))
Time frame: 3 months
Changes in serum and salivary oxidative stress parameters
Saliva Oxidative Stress Index (OSI) level : TOS/TAS
Time frame: 3 months
Changes in serum and salivary oxidative stress parameters
Saliva Native Thiol (mikromolar per liter (µmol /L))
Time frame: 3 months
Changes in serum and salivary oxidative stress parameters
Saliva Thiol/disulfid (millimolar per liter (mmol /L))
Time frame: 3 months
Changes in serum and salivary oxidative stress parameters

5 secondary outcomes

Plaque Index (PI)
Time frame: 3 months
Gingival Index (GI)
Time frame: 3 months
Bleeding on probing (BOP)
Time frame: 3 months
Clinical attachment loss(CAL)
Time frame: 3 months
Probing pocket depth (PD)
Time frame: 3 months

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2024.
Background: PubMed 25299385Loke 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 publication: PubMed 27858556Gamsiz-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 publication: PubMed 24080100DPTT 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.
Individual participant dataSharing planned: No

Related trials for Periodontitis

Recruiting
Effect of Cryotherapeutic and Nanotherapeutic Sodium Hypochlorite on Post-Operative Endodontic Pain.
Symptomatic Irreversible Pulpitis, Symptomatic Apical Periodontitis
Active, not recruitingObservational study
A Retrospective Comparative Evaluation of Omega-3 and Resveratrol Supplementation in Patients With Periodontitis
Periodontitis
Recruiting
Probiotics Versus Antibiotics as an Adjuvant to Non-surgical Periodontal Treatment Among Smokers With Stage II, Grade B Periodontitis
Probiotics, Antibiotics
Recruiting
Effects of Different Activation Techniques on Antimicrobial Photodynamic Therapy in Apical Periodontitis
Apical Periodontitis, Endodontic Retreatment
Recruiting
Ozone Gel Versus Chlorohexidine Gel as an Adjunct to Non-Surgical Treatment of Stage II Periodontitis Grade B Among Smokers Patients
Ozone Gel, Chlorohexidine Gel

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Zeliha Betul Özsağır study chair

Bezmialem VU

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Experimental in people with Periodontitis and Obstructive Sleep Apnea, run by Bezmialem Vakif University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Serum Total Antioxidant Status (TAS) level (millimolar per liter (mmol /L)) (time frame: 3 months). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03268473, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2024.