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Use of Ozone Gel as an Antimicrobial in Treatment of Periodontitis

The Effect of Ozone Gel as an Adjunct Treatment in Patients of Periodontitis According to Clinical and Biological Marker. A Split-mouth Randomized Controlled Clinical Trial.

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05905445
Enrollment
21
Registered
2023-06-15
Start date
2022-03-09
Completion date
2022-09-09
Last updated
2023-06-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Periodontal Pocket, Periodontitis

Brief summary

Periodontitis is an inflammatory disease that destroys tooth-supporting structures through oral bacterial plaque. ozone gel's act as an antimicrobial effect as an adjunct to conventional periodontal therapy (scaling and root planning). exposure of bacteria to ozone leads to the oxidation of the phospholipids and lipoproteins that comprise the bacterial cell membrane. Ozone gel has the potential to play an anti-inflammatory role in the treatment of periodontitis by monitoring both clinical and biological parameters.

Detailed description

Periodontitis is an inflammatory disease that destroys tooth-supporting structures through oral bacterial plaque. Scaling and root planning are considered the gold standard treatment for periodontal disease. Antiseptics represent an aid to the gold standard nonsurgical treatment of scaling and root planning (SRP) for periodontal disease. Adjuncts to scaling and root planning have been introduced as ozone gel. This gel represents both antimicrobial and beneficial effects while expressing safe cytocompatibility toward host tissues, which is progressively developing. The study aims to determine ozone gel's antimicrobial effect as an adjunct to conventional periodontal therapy (scaling and root planning). Material and Methods: Twenty-one patients with periodontitis were enrolled in this study. There were 58 periodontal pockets divided into two groups by a blinded split-mouth design. The control group had 28 periodontal pockets treated with scaling and root planning only, while the test group had 30 with scaling and root planning and ozone gel. Two gel applications were applied at baseline and one month after the treatment. Plaque index, bleeding on probing, probing pocket depth, and relative attachment level were recorded. Gingival crevicular fluid samples were collected from the pockets at each site for both groups at different time intervals. The GCF sample was transferred into Eppendorf tubes containing 1.5 ml of PBS buffer, and the samples were stored in a freezer at -40˚C.

Interventions

the activity of omega-3 in the ozone gel may be advantageous as a host-modulating agent in the supplemental treatment of periodontitis

Sponsors

Ghufran Falih Hassan
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Healthy volunteers
Yes

Inclusion criteria

* The patient should be systemically healthy * The patient has periodontitis equal to or more than two non-adjacent teeth, with probing pocket depth equal to or more than 4mm. * Patients capable of following orders and motivation

Exclusion criteria

* Patients with removable dentures who undergo orthodontic therapy. * Patients with teeth suffer from endo-periodontal lesions. * Patients have three months of using anti-inflammatory medications, antibiotics, immune suppressants, or oral contraceptives. * Patients having systemic conditions that affect the condition. * Pregnant or nursing mothers. * Patients who are smokers

Design outcomes

Primary

MeasureTime frameDescription
probing pocket depthbaseline to one and three monthschange of probing pocket depth by ozone gel as an adjunct to non-surgical treatment

Secondary

MeasureTime frameDescription
plaque indexbaseline to one and three monthschange in presence plaque (used disclosing agent) by ozone gel as an adjunct to non-surgical treatment
bleeding on probingbaseline to one and three monthschange in presence bleeding on probing (used UNC 15 probe) by ozone gel as an adjunct to non-surgical treatment
clinical attachment lossbaseline to one and three monthschange in presence clinical attachment loss (Used relative attachment stent) by ozone gel as an adjunct to non-surgical treatment
level of platelet-activating factor in gingival crevicular fluidbaseline to one and three monthschange in level of platelet-activating factor in gingival crevicular fluid (Used ELISA kit to measurement level of PAF in gingival crevicular fluid) by ozone gel as an adjunct to non-surgical treatment

Countries

Iraq

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026