Ozonated Water Irrigation as an Adjunct to Periodontal Therapy

Periodontal Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04556708
• Other study ID #: 2019-18
• Status: Completed
• Phase: N/A
• Start date: April 1, 2019
• Est. completion date: March 1, 2020

Study information

• Verified date: September 2020
• Source: Abant Izzet Baysal University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: March 1, 2020
• Est. primary completion date: March 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Periodontal Diseases

Intervention

Other:
• salin irrigation
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
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
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.

Locations

Country	Name	City	State
Turkey	Abant Izzet Baysal	Bolu

Sponsors (1)

Lead Sponsor	Collaborator
Abant Izzet Baysal University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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