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Completed

NCT Number: NCT05905445

Use of Ozone Gel as an Antimicrobial in Treatment of Periodontitis

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.

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Ghufran Falih Hassen

Baghdad, Iraq

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

Ozone gel

Drug

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

Primary outcomes

  1. probing pocket depth

    Time frame: baseline to one and three months

    change of probing pocket depth by ozone gel as an adjunct to non-surgical treatment

Secondary outcomes

  1. plaque index

    Time frame: baseline to one and three months

    change in presence plaque (used disclosing agent) by ozone gel as an adjunct to non-surgical treatment

  2. bleeding on probing

    Time frame: baseline to one and three months

    change in presence bleeding on probing (used UNC 15 probe) by ozone gel as an adjunct to non-surgical treatment

  3. clinical attachment loss

    Time frame: baseline to one and three months

    change in presence clinical attachment loss (Used relative attachment stent) by ozone gel as an adjunct to non-surgical treatment

  4. level of platelet-activating factor in gingival crevicular fluid

    Time frame: baseline to one and three months

    change 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

Sponsors and collaborators

Lead sponsor

Ghufran Falih Hassan

Other

Registry information

Official study title

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.

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Jun 15, 2023
Registry last updated
Jun 15, 2023

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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