Ozonated Water Irrigation as an Adjunct to Periodontal Therapy

NCT ID: NCT04556708

Last Updated: 2020-09-22

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

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-04-01

Study Completion Date

2020-03-01

Brief Summary

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The use of chlorhexidine or ozonized water in periodontal pockets accompanying NPT can provide a significant improvement in probing pocket depths compared to conventional treatment. However, the effect of subgingival ozonized water applications on VEGF and IGF levels, which are thought to play a role in the pathogenesis of periodontal disease and periodontal regeneration, should be examined.

Detailed Description

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Background: This study aims to evaluate the effects of subgingival ozonated water irrigation as an adjunct to non-surgical periodontal treatment on clinical and biochemical parameters of patients with moderate and severe periodontitis.

Methods: A total of 72 stage II and Stage III periodontitis patients were included in the study. The systemically healthy patients which were between the ages of 19 and 58 were treated non-surgically. At the end of each visit concerning periodontal treatment, the pocket of each tooth was irrigated with a sterile plastic syringe (10 mL per quadrant) with a blunt tip containing ozonated water (OW; ozone groups), 0.12% chlorhexidine digluconate (CHX groups) or saline (C; control groups) for 30-60 s. Periodontal clinical parameters, gingival crevicular fluid (GCF) vascular endothelial growth factor (VEGF) and insulin-like growth factor-1 (IGF-1) levels were evaluated at baseline and 8 weeks after periodontal treatment. All statistical data were analyzed using SPSS software.

Conditions

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Periodontal Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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saline control group

Periodontal clinical parameters and gingival crevicular fluid (GCF) samples were evaluated at baseline and 8 weeks after periodontal treatment in patients with periodontal disease.

Intervention: Non-surgical periodontal treatment (SRP and oral hygiene instructions) was performed and subgingival irrigation with saline was performed. Gingival crevicular fluid (GCF) samples were taken for vascular endothelial growth factor (VEGF) and insulin-like growth factor-1 (IGF-1) examination.

Group Type ACTIVE_COMPARATOR

salin irrigation

Intervention Type OTHER

Non-surgical periodontal treatment (SRP and oral hygiene instructions) was performed and subgingival irrigation with saline was performed. Gingival crevicular fluid (GCF) samples were taken for vascular endothelial growth factor (VEGF) and insulin-like growth factor-1 (IGF-1) examination.

ozone group

Periodontal clinical parameters and gingival crevicular fluid (GCF) samples were evaluated at baseline and 8 weeks after periodontal treatment in patients with periodontal disease.

Intervention: Non-surgical periodontal treatment (SRP and oral hygiene instructions) was performed and subgingival irrigation with ozoned water was performed. Gingival crevicular fluid (GCF) samples were taken for vascular endothelial growth factor (VEGF) and insulin-like growth factor-1 (IGF-1) examination.

Group Type ACTIVE_COMPARATOR

ozonated water irrigation

Intervention Type OTHER

Non-surgical periodontal treatment (SRP and oral hygiene instructions) was performed and subgingival irrigation with ozonated water was performed. Gingival crevicular fluid (GCF) samples were taken for vascular endothelial growth factor (VEGF) and insulin-like growth factor-1 (IGF-1) examination.

chlorhexidine group

Periodontal clinical parameters and gingival crevicular fluid (GCF) samples were evaluated at baseline and 8 weeks after periodontal treatment in patients with periodontal disease.

Intervention: Non-surgical periodontal treatment (SRP and oral hygiene instructions) was performed and subgingival irrigation with 0.12% chlorhexidine digluconate was performed. Gingival crevicular fluid (GCF) samples were taken for vascular endothelial growth factor (VEGF) and insulin-like growth factor-1 (IGF-1) examination.

Group Type ACTIVE_COMPARATOR

chlorhexidine irrigation

Intervention Type OTHER

Non-surgical periodontal treatment (SRP and oral hygiene instructions) was performed and subgingival irrigation with 0.12% chlorhexidine digluconate was performed. Gingival crevicular fluid (GCF) samples were taken for vascular endothelial growth factor (VEGF) and insulin-like growth factor-1 (IGF-1) examination.

Interventions

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salin irrigation

Non-surgical periodontal treatment (SRP and oral hygiene instructions) was performed and subgingival irrigation with saline was performed. Gingival crevicular fluid (GCF) samples were taken for vascular endothelial growth factor (VEGF) and insulin-like growth factor-1 (IGF-1) examination.

Intervention Type OTHER

ozonated water irrigation

Non-surgical periodontal treatment (SRP and oral hygiene instructions) was performed and subgingival irrigation with ozonated water was performed. Gingival crevicular fluid (GCF) samples were taken for vascular endothelial growth factor (VEGF) and insulin-like growth factor-1 (IGF-1) examination.

Intervention Type OTHER

chlorhexidine irrigation

Non-surgical periodontal treatment (SRP and oral hygiene instructions) was performed and subgingival irrigation with 0.12% chlorhexidine digluconate was performed. Gingival crevicular fluid (GCF) samples were taken for vascular endothelial growth factor (VEGF) and insulin-like growth factor-1 (IGF-1) examination.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* good general health without a history of systemic disease (hyperthyroid, diabetes, etc.)
* ≥ 20 teeth
* having not received periodontal treatment within the past 6 months
* no contraindication for periodontal therapy and ozone application
* presenting moderate-to-severe periodontitis according to criteria outlined by 2017 World Workshop.

Exclusion Criteria

* smoking
* use of anti-inflammatory and antibiotic drugs within the past 6 months
* pregnancy, lactation or use of oral contraceptives
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Abant Izzet Baysal University

OTHER

Sponsor Role lead

Responsible Party

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Ozge Gokturk

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ozge Gokturk

Role: PRINCIPAL_INVESTIGATOR

Abant Izzet Baysal

Locations

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Abant Izzet Baysal

Bolu, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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2019-18

Identifier Type: -

Identifier Source: org_study_id

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