Ozonated Water Irrigation as an Adjunct to Periodontal Therapy

Sponsor
Abant Izzet Baysal University (Other)
Overall Status
Completed
CT.gov ID
NCT04556708
Collaborator
(none)
72
1
3
11
6.5

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: salin irrigation
  • Other: ozonated water irrigation
  • Other: chlorhexidine irrigation
N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
72 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Prevention
Official Title:
Ozonated Water Irrigation as an Adjunct to Mechanical Periodontal Therapy in Patients With Periodontitis: A Randomized Clinical Trial
Actual Study Start Date :
Apr 1, 2019
Actual Primary Completion Date :
Mar 1, 2020
Actual Study Completion Date :
Mar 1, 2020

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: saline control group

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
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.

Active Comparator: ozone group

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
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.

Active Comparator: chlorhexidine group

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
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.

Outcome Measures

Primary Outcome Measures

  1. vascular endothelial growth factor level [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 Outcome Measures

  1. insulin-like growth factor-1 level [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 [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 [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 [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 [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 [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 60 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Abant Izzet Baysal Bolu Turkey 14100

Sponsors and Collaborators

  • Abant Izzet Baysal University

Investigators

  • Principal Investigator: Ozge Gokturk, Abant Izzet Baysal

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Ozge Gokturk, Principal Investigator, Abant Izzet Baysal University
ClinicalTrials.gov Identifier:
NCT04556708
Other Study ID Numbers:
  • 2019-18
First Posted:
Sep 21, 2020
Last Update Posted:
Sep 22, 2020
Last Verified:
Sep 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Ozge Gokturk, Principal Investigator, Abant Izzet Baysal University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 22, 2020