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Use of the Ozone in Periodontal Treatment

Primary Purpose

Chronic Periodontitis

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Gaseous ozone
SRP plus placebo
Sponsored by
Çanakkale Onsekiz Mart University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Periodontitis focused on measuring Periodontal treatment, Ozone, oxidative stress

Eligibility Criteria

30 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Inonu University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Control group

Gaseous ozone group

Arm Description

SRP plus placebo

SRP plus gaseous ozone [1 W (100 mJ, 10 Hz)]

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
February 14, 2018
Last Updated
February 22, 2018
Sponsor
Çanakkale Onsekiz Mart University
Collaborators
Inonu University
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1. Study Identification

Unique Protocol Identification Number
NCT03444350
Brief Title
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

2. Study Status

Record Verification Date
February 2018
Overall Recruitment Status
Completed
Study Start Date
May 1, 2012 (Actual)
Primary Completion Date
May 23, 2015 (Actual)
Study Completion Date
August 11, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Çanakkale Onsekiz Mart University
Collaborators
Inonu University

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Periodontitis
Keywords
Periodontal treatment, Ozone, oxidative stress

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
RANDOMIZED CONTROLLED TRIAL
Masking
ParticipantInvestigator
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.
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control group
Arm Type
Active Comparator
Arm Description
SRP plus placebo
Arm Title
Gaseous ozone group
Arm Type
Experimental
Arm Description
SRP plus gaseous ozone [1 W (100 mJ, 10 Hz)]
Intervention Type
Device
Intervention Name(s)
Gaseous ozone
Other Intervention Name(s)
Ozone DTA
Intervention Description
SRP plus gaseous ozone
Intervention Type
Device
Intervention Name(s)
SRP plus placebo
Intervention Description
only SRP
Primary Outcome Measure Information:
Title
Laboratory findings
Description
The total antioxidant status levels ( mmol/L) were determined in the saliva samples.
Time Frame
One month
Secondary Outcome Measure Information:
Title
Clinical findings
Description
Probing depth was measured the distance between the gingival margin and the deepest aspect of the pocket (mm).
Time Frame
One month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Abubekir Eltas, Ass. Prof.
Organizational Affiliation
Inonu University
Official's Role
Study Chair
Facility Information:
Facility Name
Inonu University
City
Malatya
ZIP/Postal Code
44000
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing 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.
Citations:
PubMed Identifier
30673028
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.
Results Reference
derived

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Use of the Ozone in Periodontal Treatment

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