Use of the Ozone in Periodontal Treatment

Ç

Çanakkale Onsekiz Mart University

Status

Completed

Conditions

Chronic Periodontitis

Treatments

Device: Gaseous ozone
Device: SRP plus placebo

Study type

Interventional

Funder types

Other

Identifiers

NCT03444350
Inonu University

Details and patient eligibility

About

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.

Full 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.

Enrollment

40 patients

Sex

All

Ages

30+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

40 participants in 2 patient groups

Control group
Active Comparator group
Description:
SRP plus placebo
Treatment:
Device: SRP plus placebo
Gaseous ozone group
Experimental group
Description:
SRP plus gaseous ozone [1 W (100 mJ, 10 Hz)]
Treatment:
Device: Gaseous ozone

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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