Ozonated Water Irrigation as an Adjunct to Periodontal Therapy

NCT04556708 | Completed

• 1 other identifier: 2019-18
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

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.

Conditions

Periodontal Diseases

Keywords

ozone; periodontitis; chlorhexidine digluconate; root planing

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• insulin-like growth factor-1 level

  Baseline and after 8 weeks

• Probing pocket depth

  Baseline and after 8 weeks

• Clinical attachment level

  Baseline and after 8 weeks

• Gingival index

  Baseline and after 8 weeks

• Plaque index

  Baseline and after 8 weeks

Study Arms (3)

saline control group

ACTIVE COMPARATOR

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.

Other: salin irrigation

ozone group

ACTIVE COMPARATOR

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.

Other: ozonated water irrigation

chlorhexidine group

ACTIVE COMPARATOR

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.

Other: chlorhexidine irrigation

Interventions

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.

saline control group

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.

ozone group

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.

chlorhexidine group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• smoking
• use of anti-inflammatory and antibiotic drugs within the past 6 months
• pregnancy, lactation or use of oral contraceptives

Sponsors & Collaborators

• Abant Izzet Baysal University: lead

Study Sites (1)

Abant Izzet Baysal

Bolu, 14100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Periodontal Diseases; Periodontitis

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases

Study Officials

• Ozge Gokturk

  Abant Izzet Baysal

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 15, 2020
• First Posted: September 21, 2020
• Study Start: April 1, 2019
• Primary Completion: March 1, 2020
• Study Completion: March 1, 2020
• Last Updated: September 22, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)