Effects of Ozone Therapy as an Adjunct to Periodontal Treatment

NCT03652558 | Completed

• 1 other identifier: Tasdemir
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief Summary

This randomized, placebo controlled, split-mouth clinical study trial evaluates the effects of Ozone therapy on clinical and biochemical parameters. Total of 20 participants completed the study . Periodontal parameters were evaluated at baseline and 3 months following periodontal therapy. All participants were treated non-surgically. Topical gaseous ozone was applied into periodontal pockets. Gingival crevicular fluid pentraxin-3 (PTX-3), interleukin-1β (IL-1β) and high sensitivity C-reactive protein (Hs-CRP) were evaluated.

Conditions

Periodontitis

Outcome Measures

Primary Outcomes (1)

• Periodontal disease parameters change

  Probing depth (mm) were evaluated by periodontal probe.

  Examinations were performed at baseline and 3 months after periodontal therapy. Changes is determined with baseline values - 3 months after periodontal treatment.

Secondary Outcomes (1)

• Gingival crevicular inflammatory parameter change

  inflammatory biochemical parameters were analyzed at baseline and 3 months after periodontal therapy and changes is determined with baseline values - 3 months after periodontal therapy.

Study Arms (2)

ozone group

EXPERIMENTAL

topical gaseous ozone was applied into periodontal pockets during active periodontal therapy

Device: Ozone application with the Ozonytron XL device

non-ozone group

NO INTERVENTION

Only active periodontal therapy was performed

Interventions

Ozone application with the Ozonytron XL device DEVICE

An ozone generator (Ozonytron; Bionix, Munchen, Germany) with an KPX probe (CA Probe; Ozonytron, Bionix, Munchen, Germany) was used for OT. Topical gaseous ozone was applied into the periodontal pocket twice a week for 2 weeks based on the manufacturer's instructions. Ozone applications were at 75% power for 30 seconds (75 µg/ml). Ozone applications were performed by an experienced investigator. Ozone applications in the control side were simulated without starting the ozone generator

ozone group

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• to 64 years of age
• Generalized chronic periodontitis(Armitage, 1999)
• Systemically healthy
• More than 20 teeth (excluding third molars)

You may not qualify if:

• Periodontal treatment within 6 months
• Antibiotic use within the previous 3 months
• Pregnancy and lactation
• Past or current smoking and alcohol consumption
• Contraindications for OT
• Patients with class II and III furcation defects(Staffileno, 1969)

Sponsors & Collaborators

• TC Erciyes University: lead

MeSH Terms

Conditions

Periodontitis

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Study Officials

• Zekeriya Taşdemir, Phd

  TC Erciyes University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Investigators who evaluate the clinical and biochemical parameters did no know the groups. And participants did not know ozone device work or not when holding the probe.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Model Details: In this study the investigators select the split mouth study design to eleminate host effects on healing.

Study Record Dates

• First Submitted: August 22, 2018
• First Posted: August 29, 2018
• Study Start: January 10, 2017
• Primary Completion: January 10, 2018
• Study Completion: February 10, 2018
• Last Updated: August 29, 2018

Record last verified: 2018-08