Clinical trial NCT03652558: Effects of Ozone Therapy as an Adjunct to Periodontal Treatment
Official title: The Effects of Ozone Therapy as an Adjunct to Periodontal Treatment: A Randomized Split-Mouth Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Periodontitis
Lead sponsor: TC Erciyes University
Sponsor class: OTHER
First posted: 2018-08-29
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: In this study the investigators select the split mouth study design to eleminate host effects on healing.
Primary purpose: TREATMENT

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.

Detailed 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.

Eligibility criteria: 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)

Primary outcomes:
measure: Periodontal disease parameters change
timeFrame: Examinations were performed at baseline and 3 months after periodontal therapy. Changes is determined with baseline values - 3 months after periodontal treatment.
Secondary outcomes:
measure: Gingival crevicular inflammatory parameter change
timeFrame: 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.
Other outcomes:
Locations:
Study officials:
affiliation: TC Erciyes University
name: Zekeriya Taşdemir, Phd
role: PRINCIPAL_INVESTIGATOR
References: