Use of the Ozone in Periodontal Treatment

Chronic Periodontitis Clinical Trial

Official title:

Evaluating the Clinical and Laboratory Effects of the Use of Ozone in nonsurgıcal perıodontal Treatment : a Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03444350
• Other study ID #: Inonu University
• Status: Completed
• Phase: N/A
• First received: February 14, 2018
• Last updated: February 22, 2018
• Start date: May 1, 2012
• Est. completion date: August 11, 2016

Study information

• Verified date: February 2018
• Source: Çanakkale Onsekiz Mart University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: August 11, 2016
• Est. primary completion date: May 23, 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 30 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Periodontitis
• Periodontitis

Intervention

Device:
• Gaseous ozone
SRP plus gaseous ozone
• SRP plus placebo
only SRP

Locations

Country	Name	City	State
Turkey	Inonu University	Malatya

Sponsors (2)

Lead Sponsor	Collaborator
Çanakkale Onsekiz Mart University	Inonu University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Laboratory findings	The total antioxidant status levels ( mmol/L) were determined in the saliva samples.	One month
Secondary	Clinical findings	Probing depth was measured the distance between the gingival margin and the deepest aspect of the pocket (mm).	One month