Clinical trial NCT04556708: Ozonated Water Irrigation as an Adjunct to Periodontal Therapy
Official title: Ozonated Water Irrigation as an Adjunct to Mechanical Periodontal Therapy in Patients With Periodontitis: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Periodontal Diseases
Keywords: ozone
periodontitis
chlorhexidine digluconate
root planing
Lead sponsor: Abant Izzet Baysal University
Sponsor class: OTHER
First posted: 2020-09-21
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: vascular endothelial growth factor level
timeFrame: Baseline and after 8 weeks
Secondary outcomes:
measure: insulin-like growth factor-1 level
timeFrame: Baseline and after 8 weeks
measure: Probing pocket depth
timeFrame: Baseline and after 8 weeks
measure: Clinical attachment level
timeFrame: Baseline and after 8 weeks
measure: Gingival index
timeFrame: Baseline and after 8 weeks
measure: Plaque index
timeFrame: Baseline and after 8 weeks
measure: Bleeding on probing
timeFrame: Baseline and after 8 weeks
Other outcomes:
Locations:
city: Bolu
country: Turkey
facility: Abant Izzet Baysal
Study officials:
affiliation: Abant Izzet Baysal
name: Ozge Gokturk
role: PRINCIPAL_INVESTIGATOR
References: