Effects of Ozone Therapy as an Adjunct to Periodontal Treatment

Periodontitis Clinical Trial

Official title:

The Effects of Ozone Therapy as an Adjunct to Periodontal Treatment: A Randomized Split-Mouth Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03652558
• Other study ID #: Tasdemir
• Status: Completed
• Phase: N/A
• Start date: January 10, 2017
• Est. completion date: February 10, 2018

Study information

• Verified date: August 2018
• Source: TC Erciyes University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Ozone therapy (OT) is very popular in medicine. Especially it use for wound healing and antibacterial properties. This randomized, placebo controlled, randomized split-mouth clinical study evaluates the effects of ozone therapy on clinical and biochemical parameters. Total of 20 participants completed the study (10 males, 10 females). Periodontal parameters, including plaque index (PI), gingival index (GI), probing depth (PD), percentage of bleeding on probing, percentage of pockets deeper than 5 mm and clinical attachment level (CAL), and percentage of ≥3 mm clinical attachment level. 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 twice a week for 2 weeks during active periodontal therapy. Gingival crevicular fluid pentraxin-3 (PTX-3), interleukin-1β (IL-1β) and high sensitivity C-reactive protein (Hs-CRP) were evaluated.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: February 10, 2018
• Est. primary completion date: January 10, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 64 Years

Eligibility

Inclusion Criteria:

• 18 to 64 years of age

• Generalized chronic periodontitis(Armitage, 1999)

• Systemically healthy

• More than 20 teeth (excluding third molars)

Exclusion Criteria:

• 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)

Related Conditions & MeSH terms

• Periodontitis

Intervention

Device:
• Ozone application with the Ozonytron XL 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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
TC Erciyes University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Gingival crevicular inflammatory parameter change	Gingival crevicular fluid pentraxin-3 (PTX-3) ng/mL was evaluated.	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.