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Ozonated Water Irrigation as an Adjunct to Periodontal Therapy

Primary Purpose

Periodontal Diseases

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
salin irrigation
ozonated water irrigation
chlorhexidine irrigation
Sponsored by
Abant Izzet Baysal University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Periodontal Diseases focused on measuring ozone, periodontitis, chlorhexidine digluconate, root planing

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Abant Izzet Baysal

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

saline control group

ozone group

chlorhexidine group

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

vascular endothelial growth factor level
Changes in the concentration of vascular endothelial growth factor in all groups within 8 weeks after periodontal treatment were measured.

Secondary Outcome Measures

insulin-like growth factor-1 level
Changes in the concentration of insulin-like growth factor-1 in all groups within 8 weeks after periodontal treatment were measured.
Probing pocket depth
The changes in probing pocket depth before and after periodontal treatment were measured in 72 participants to determine the severity of disease and clinic outcome.
Clinical attachment level
The changes in clinical attachment level before and after periodontal treatment were measured in 72 participants to determine the severity of disease and clinic outcome.
Gingival index
The changes in gingival index level before and after periodontal treatment were measured in 72 participants to determine the severity of the disease.
Plaque index
The changes in gingival index level before and after periodontal treatment were measured in 72 participants to determine the severity of disease and clinic status.
Bleeding on probing
The changes in bleeding on probing before and after periodontal treatment were measured in 72 participants to record for classifying and evaluate (apically) gingival inflammation.

Full Information

First Posted
September 15, 2020
Last Updated
September 19, 2020
Sponsor
Abant Izzet Baysal University
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1. Study Identification

Unique Protocol Identification Number
NCT04556708
Brief Title
Ozonated Water Irrigation as an Adjunct to Periodontal Therapy
Official Title
Ozonated Water Irrigation as an Adjunct to Mechanical Periodontal Therapy in Patients With Periodontitis: A Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
April 1, 2019 (Actual)
Primary Completion Date
March 1, 2020 (Actual)
Study Completion Date
March 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Abant Izzet Baysal University

4. Oversight

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

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Periodontal Diseases
Keywords
ozone, periodontitis, chlorhexidine digluconate, root planing

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
72 (Actual)

8. Arms, Groups, and Interventions

Arm Title
saline control group
Arm Type
Active Comparator
Arm Description
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.
Arm Title
ozone group
Arm Type
Active Comparator
Arm Description
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.
Arm Title
chlorhexidine group
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
salin irrigation
Intervention Description
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
Intervention Name(s)
ozonated water irrigation
Intervention Description
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
Intervention Name(s)
chlorhexidine irrigation
Intervention Description
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.
Primary Outcome Measure Information:
Title
vascular endothelial growth factor level
Description
Changes in the concentration of vascular endothelial growth factor in all groups within 8 weeks after periodontal treatment were measured.
Time Frame
Baseline and after 8 weeks
Secondary Outcome Measure Information:
Title
insulin-like growth factor-1 level
Description
Changes in the concentration of insulin-like growth factor-1 in all groups within 8 weeks after periodontal treatment were measured.
Time Frame
Baseline and after 8 weeks
Title
Probing pocket depth
Description
The changes in probing pocket depth before and after periodontal treatment were measured in 72 participants to determine the severity of disease and clinic outcome.
Time Frame
Baseline and after 8 weeks
Title
Clinical attachment level
Description
The changes in clinical attachment level before and after periodontal treatment were measured in 72 participants to determine the severity of disease and clinic outcome.
Time Frame
Baseline and after 8 weeks
Title
Gingival index
Description
The changes in gingival index level before and after periodontal treatment were measured in 72 participants to determine the severity of the disease.
Time Frame
Baseline and after 8 weeks
Title
Plaque index
Description
The changes in gingival index level before and after periodontal treatment were measured in 72 participants to determine the severity of disease and clinic status.
Time Frame
Baseline and after 8 weeks
Title
Bleeding on probing
Description
The changes in bleeding on probing before and after periodontal treatment were measured in 72 participants to record for classifying and evaluate (apically) gingival inflammation.
Time Frame
Baseline and after 8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ozge Gokturk
Organizational Affiliation
Abant Izzet Baysal
Official's Role
Principal Investigator
Facility Information:
Facility Name
Abant Izzet Baysal
City
Bolu
ZIP/Postal Code
14100
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

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Ozonated Water Irrigation as an Adjunct to Periodontal Therapy

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