Ozonated Water Irrigation as an Adjunct to Periodontal Therapy

Study Overview
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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.

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

Conditions
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Periodontal Diseases

Intervention / Treatment
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* Other: salin irrigation
* Other: ozonated water irrigation
* Other: chlorhexidine irrigation


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: saline control group<br>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<br>* 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.<br>|
| Active Comparator: ozone group<br>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<br>* 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.<br>|
| Active Comparator: chlorhexidine group<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Baseline and after 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Baseline and after 8 weeks | 
| 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. | Baseline and after 8 weeks | 
| 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. | Baseline and after 8 weeks | 
| 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. | Baseline and after 8 weeks | 
| 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. | Baseline and after 8 weeks | 
| 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. | Baseline and after 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ozone, periodontitis, chlorhexidine digluconate, root planing