Use of the Ozone in Periodontal Treatment

Not Applicable

Completed

• Conditions: Chronic Periodontitis
• Interventions: Device: Gaseous ozone; Device: SRP plus placebo

• Registration Number: NCT03444350
• Lead Sponsor: Çanakkale Onsekiz Mart University

Brief Summary

The purpose of this study is to evaluate the clinicaland laboratory (as oxidative stress and pro-inflammatory mediators) effects of the use of gaseous ozone in periodontal treatment in addition to scaling and root planning.

The study population consisted of 40 patients with CP (chronic periodontitis). It was performed with two groups; The Test Group, and the Control Group. SRP plus gaseous ozone \[1 W (100 mJ, 10 Hz)\] was applied to the Test Group. The Control Group, on the other hand, had only SRP.The clinical periodontal parameters were performed and saliva samples were taken before SRP (baseline) and 1 month after treatment. The periodontal examination involved assessing the plaque index, gingival index , probing depth, and clinical attachment level. The total antioxidant status, total oxidant status, nitric oxide, 8-hidroxi-deoksiguanosine, myeloperoxidase, glutathione, malondialdehyde and transforming growth factor-beta levels were determined in the saliva samples.

Detailed Description

The study has been designed in a randomized parallelly-controlled and double-blinded design as a full-mouth clinical trial. The duration of the study was 1 month.

The study was performed with two groups; The Test Group, and the Control Group. SRP plus gaseous ozone \[1 W (100 mJ, 10 Hz), (n=20)\] was applied to the Test Group.

The Control Group, on the other hand, had SRP plus placebo (n=20). The patients were distributed in random order to the 2 groups (each group had 20 patients). One patient in the Ozone Group and 2 patients in the Control Group left the study.

The following clinical periodontal parameters were performed immediately before SRP (baseline), and 1 month after treatment for each test and control groups. Plaque index, GI, PD and CAL were recorded. All clinical parameter measurements were used a manual periodontal probe (PCP- 12, Hu-Friedy, Chicago, IL, USA).

The total antioxidant status, total oxidant status, nitric oxide, 8-hidroxi-deoksiguanosine, myeloperoxidase, glutathione, malondialdehyde and transforming growth factor-beta levels were determined in the saliva samples.

Study Timeline

• Study Start: 2012-05-01
• Primary Completion: 2015-05-23
• Study Completion: 2016-08-11
• Status Verified: 2018-02
• Study First Submitted: 2018-02-14
• Study First Submitted QC: 2018-02-22
• Last Update Submitted: 2018-02-22
• Study First Posted: 2018-02-23
• Last Update Posted: 2018-02-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

1. patients having had generalize CP which were agreed upon by consensus at the World Workshop in Periodontics in 1999 [24];
2. three or more teeth having at least two quadrants with probing depth between 4 and 6 mm and radiographic signs of bone loss;
3. aged 30 years and above;
4. a minimum of 20 teeth.

Exclusion Criteria

1. received periodontal therapy within the last 12 months;
2. systemic diseases which could affect periodontal treatment outcomes;
3. having taken systemic antibiotics within the last 6 months;
4. pregnancy or breast-feeding for female patients.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Gaseous ozone group	Gaseous ozone	SRP plus gaseous ozone \[1 W (100 mJ, 10 Hz)\]
Control group	SRP plus placebo	SRP plus placebo

Primary Outcome Measures

Name	Time	Method
Laboratory findings	One month	The total antioxidant status levels ( mmol/L) were determined in the saliva samples.

Secondary Outcome Measures

Name	Time	Method
Clinical findings	One month	Probing depth was measured the distance between the gingival margin and the deepest aspect of the pocket (mm).

Trial Locations

Locations (1)

Inonu University; 🇹🇷 Malatya, Turkey