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Ozonated Water Irrigation as an Adjunct to Periodontal Therapy

A

Abant Izzet Baysal University

Status

Completed

Conditions

Periodontal Diseases

Treatments

Other: ozonated water irrigation
Other: chlorhexidine irrigation
Other: salin irrigation

Study type

Interventional

Funder types

Other

Identifiers

NCT04556708
2019-18

Details and patient eligibility

About

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.

Full 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.

Enrollment

72 patients

Sex

All

Ages

18 to 60 years old

Volunteers

No 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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

72 participants in 3 patient groups

saline control group
Active Comparator group
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.
Treatment:
Other: salin irrigation
ozone group
Active Comparator group
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.
Treatment:
Other: ozonated water irrigation
chlorhexidine group
Active Comparator group
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.
Treatment:
Other: chlorhexidine irrigation

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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