Use of the Ozone in Periodontal Treatment
Evaluating the Clinical and Laboratory Effects of the Use of Ozone in nonsurgıcal perıodontal Treatment : a Randomized Controlled Trial
1 other identifier
interventional
40
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started May 2012
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 23, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
August 11, 2016
CompletedFirst Submitted
Initial submission to the registry
February 14, 2018
CompletedFirst Posted
Study publicly available on registry
February 23, 2018
CompletedFebruary 23, 2018
February 1, 2018
3.1 years
February 14, 2018
February 22, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Laboratory findings
The total antioxidant status levels ( mmol/L) were determined in the saliva samples.
One month
Secondary Outcomes (1)
Clinical findings
One month
Study Arms (2)
Control group
ACTIVE COMPARATORSRP plus placebo
Gaseous ozone group
EXPERIMENTALSRP plus gaseous ozone \[1 W (100 mJ, 10 Hz)\]
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Çanakkale Onsekiz Mart Universitylead
- Inonu Universitycollaborator
Study Sites (1)
Inonu University
Malatya, 44000, Turkey (Türkiye)
Related Publications (1)
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.
PMID: 30673028DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Abubekir Eltas, Ass. Prof.
Inonu University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Masking Details
- 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.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director
Study Record Dates
First Submitted
February 14, 2018
First Posted
February 23, 2018
Study Start
May 1, 2012
Primary Completion
May 23, 2015
Study Completion
August 11, 2016
Last Updated
February 23, 2018
Record last verified: 2018-02
Data Sharing
- IPD Sharing
- Will not share
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.