Clinical trial NCT03444350: Use of the Ozone in Periodontal Treatment
Official title: Evaluating the Clinical and Laboratory Effects of the Use of Ozone in nonsurgıcal perıodontal Treatment : a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Periodontitis
Keywords: Periodontal treatment
Ozone
oxidative stress
Lead sponsor: Çanakkale Onsekiz Mart University
Sponsor class: OTHER
Collaborators: name: Inonu University
First posted: 2018-02-23
Enrollment: 40
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: RANDOMIZED CONTROLLED TRIAL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Laboratory findings
timeFrame: One month
Secondary outcomes:
measure: Clinical findings
timeFrame: One month
Other outcomes:
Locations:
city: Malatya
country: Turkey
facility: Inonu University
Study officials:
affiliation: Inonu University
name: Abubekir Eltas, Ass. Prof.
role: STUDY_CHAIR
References:
citation: Seydanur Dengizek E, Serkan D, Abubekir E, Aysun Bay K, Onder O, Arife C. Evaluating clinical and laboratory effects of ozone in non-surgical periodontal treatment: a randomized controlled trial. J Appl Oral Sci. 2019 Jan 14;27:e20180108. doi: 10.1590/1678-7757-2018-0108.