Ozonated Water Irrigation as an Adjunct to Periodontal Therapy

Not Applicable

Completed

• Conditions: Periodontal Diseases
• Interventions: Other: salin irrigation; Other: ozonated water irrigation; Other: chlorhexidine irrigation

• Registration Number: NCT04556708
• Lead Sponsor: Abant Izzet Baysal University

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.

Study Timeline

• Study Start: 2019-04-01
• Primary Completion: 2020-03-01
• Study Completion: 2020-03-01
• Status Verified: 2020-09
• Study First Submitted: 2020-09-15
• Study First Submitted QC: 2020-09-15
• Last Update Submitted: 2020-09-19
• Study First Posted: 2020-09-21
• Last Update Posted: 2020-09-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 72

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
saline control group	salin irrigation	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.
ozone group	ozonated water irrigation	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.
chlorhexidine group	chlorhexidine irrigation	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.

Primary Outcome Measures

Name	Time	Method
vascular endothelial growth factor level	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.

Secondary Outcome Measures

Name	Time	Method
Gingival index	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.
Probing pocket depth	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.
Clinical attachment level	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.
Bleeding on probing	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.
insulin-like growth factor-1 level	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.
Plaque index	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.

Trial Locations

Locations (1)

Abant Izzet Baysal; 🇹🇷 Bolu, Turkey