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Completed

NCT Number: NCT04556708

Ozonated Water Irrigation as an Adjunct to Periodontal Therapy

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.

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Key information

Conditions

Periodontal Diseases Mouth Diseases Periodontitis Stomatognathic Diseases

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Abant Izzet Baysal

Bolu, 14100, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

salin irrigation

Other

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.

ozonated water irrigation

Other

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.

chlorhexidine irrigation

Other

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 outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

Sponsors and collaborators

Lead sponsor

Abant Izzet Baysal University

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Sep 21, 2020
Registry last updated
Sep 22, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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