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Use of the Ozone in Periodontal Treatment

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03444350
Recruitment Status : Completed
First Posted : February 23, 2018
Last Update Posted : February 23, 2018
Sponsor:
Collaborator:
Inonu University
Information provided by (Responsible Party):
Abubekir Eltas, 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.


Condition or disease Intervention/treatment Phase
Chronic Periodontitis Device: Gaseous ozone Device: SRP plus placebo Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: RANDOMIZED CONTROLLED TRIAL
Masking: Double (Participant, Investigator)
Masking Description:

The clinician who performed the therapy (S.D.) was not informed about the modality of the treatment till the first session of each patient (right at this moment, a sealed envelope was opened and the clinician was then able to see the treatment modality). The results of the study were evaluated in a blinded manner (both before treatment and after treatment).

The ozone was applied in the gingival sulcus of all teeth with a fine-tipped tool placed in the periodontal pocket. It was moved in the apical-coronal direction in a sweeping motion. Within 30 seconds, this application was applied in mesial, distal, buccal, and lingual manner. No ozone application was used in the Control Group, and they received only placebo.

Primary Purpose: Treatment
Official Title: Evaluating the Clinical and Laboratory Effects of the Use of Ozone in nonsurgıcal perıodontal Treatment : a Randomized Controlled Trial
Actual Study Start Date : May 1, 2012
Actual Primary Completion Date : May 23, 2015
Actual Study Completion Date : August 11, 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ozone

Arm Intervention/treatment
Active Comparator: Control group
SRP plus placebo
Device: SRP plus placebo
only SRP

Experimental: Gaseous ozone group
SRP plus gaseous ozone [1 W (100 mJ, 10 Hz)]
Device: Gaseous ozone
SRP plus gaseous ozone
Other Name: Ozone DTA




Primary Outcome Measures :
  1. Laboratory findings [ Time Frame: One month ]
    The total antioxidant status levels ( mmol/L) were determined in the saliva samples.


Secondary Outcome Measures :
  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).



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Ages Eligible for Study:   30 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03444350


Locations
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Turkey
Inonu University
Malatya, Turkey, 44000
Sponsors and Collaborators
Çanakkale Onsekiz Mart University
Inonu University
Investigators
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Study Chair: Abubekir Eltas, Ass. Prof. Inonu University
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Abubekir Eltas, Director, Çanakkale Onsekiz Mart University
ClinicalTrials.gov Identifier: NCT03444350    
Other Study ID Numbers: Inonu University
First Posted: February 23, 2018    Key Record Dates
Last Update Posted: February 23, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan 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. Inonu University Ethics Committee approved the study protocol in accordance with the Helsinki Declaration. Informed Consent Form were received from the participants with their signatures. The participating patients were selected from Inonu University, Department of Periodontology Patient Pool. 40 patients constituted the Study Group.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Abubekir Eltas, Çanakkale Onsekiz Mart University:
Periodontal treatment
Ozone
oxidative stress
Additional relevant MeSH terms:
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Periodontitis
Chronic Periodontitis
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases