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Completed

NCT Number: NCT03444350

Use of the Ozone in Periodontal Treatment

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.

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Key information

Age range

30 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Inonu University

Malatya, 44000, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Gaseous ozone

Device

SRP plus gaseous ozone

Other names: Ozone DTA

SRP plus placebo

Device

only SRP

Primary outcomes

  1. Laboratory findings

    Time frame: One month

    The total antioxidant status levels ( mmol/L) were determined in the saliva samples.

Secondary outcomes

  1. Clinical findings

    Time frame: One month

    Probing depth was measured the distance between the gingival margin and the deepest aspect of the pocket (mm).

Sponsors and collaborators

Lead sponsor

Çanakkale Onsekiz Mart University

Other

Collaborators

  • Inonu University

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2015
Study completion
2016
First posted
Feb 23, 2018
Registry last updated
Feb 23, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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