Ozonated Water Irrigation as an Adjunct to Periodontal Therapy

September 19, 2020 updated by: Ozge Gokturk, Abant Izzet Baysal University

Ozonated Water Irrigation as an Adjunct to Mechanical Periodontal Therapy in Patients With Periodontitis: A Randomized Clinical Trial

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
72

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Bolu, Turkey, 14100
        • Abant Izzet Baysal

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: 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.
Other: 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.
Active Comparator: 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.
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.
Active Comparator: 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.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
vascular endothelial growth factor level
Time Frame: Baseline and after 8 weeks
Changes in the concentration of vascular endothelial growth factor in all groups within 8 weeks after periodontal treatment were measured.
Baseline and after 8 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
insulin-like growth factor-1 level
Time Frame: Baseline and after 8 weeks
Changes in the concentration of insulin-like growth factor-1 in all groups within 8 weeks after periodontal treatment were measured.
Baseline and after 8 weeks
Probing pocket depth
Time Frame: Baseline and after 8 weeks
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.
Baseline and after 8 weeks
Clinical attachment level
Time Frame: Baseline and after 8 weeks
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.
Baseline and after 8 weeks
Gingival index
Time Frame: Baseline and after 8 weeks
The changes in gingival index level before and after periodontal treatment were measured in 72 participants to determine the severity of the disease.
Baseline and after 8 weeks
Plaque index
Time Frame: Baseline and after 8 weeks
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.
Baseline and after 8 weeks
Bleeding on probing
Time Frame: Baseline and after 8 weeks
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.
Baseline and after 8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Abant Izzet Baysal University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 15, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 15, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 21, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 22, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 19, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2019-18 (Other Identifier: Gemini Eye Clinics)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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