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.

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.

Study Overview

• Status: Completed
• Conditions: Periodontitis; Periodontal Pocket
• Intervention / Treatment: Drug: ozone gel

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.

• Study Type: Interventional
• Enrollment (Actual): 21
• Phase: Phase 1

Contacts and Locations

Study Locations

• Iraq
  • Baghdad, Iraq
    • Ghufran Falih Hassen

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ozone gel with conventional scaling and root planning; administered ozone gel in the probing pocket depth after scaling and root planning by a disposable plastic syringe with a blunt tip until the access ozone became out of the pocket. this procedure is made at baseline and in the first month. instructed the patient not to eat or drink for at least 30 minutes	Drug: ozone gel; the activity of omega-3 in the ozone gel may be advantageous as a host-modulating agent in the supplemental treatment of periodontitis
No Intervention: only conventional scaling and root planning; only scaling and root planning without any intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
probing pocket depth	change of probing pocket depth by ozone gel as an adjunct to non-surgical treatment	baseline to one and three months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
plaque index	change in presence plaque (used disclosing agent) by ozone gel as an adjunct to non-surgical treatment	baseline to one and three months
bleeding on probing	change in presence bleeding on probing (used UNC 15 probe) by ozone gel as an adjunct to non-surgical treatment	baseline to one and three months
clinical attachment loss	change in presence clinical attachment loss (Used relative attachment stent) by ozone gel as an adjunct to non-surgical treatment	baseline to one and three months
level of platelet-activating factor in gingival crevicular fluid	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	baseline to one and three months

Collaborators and Investigators

• Sponsor: Ghufran Falih Hassan

Publications and helpful links

General Publications

• Colombo M, Gallo S, Garofoli A, Poggio C, Arciola CR, Scribante A. Ozone Gel in Chronic Periodontal Disease: A Randomized Clinical Trial on the Anti-Inflammatory Effects of Ozone Application. Biology (Basel). 2021 Jul 6;10(7):625. doi: 10.3390/biology10070625.

Study record dates

Study Major Dates

• Study Start (Actual): March 9, 2022
• Primary Completion (Actual): September 9, 2022
• Study Completion (Actual): September 9, 2022

Study Registration Dates

• First Submitted: May 26, 2023
• First Submitted That Met QC Criteria: June 7, 2023
• First Posted (Actual): June 15, 2023

Study Record Updates

• Last Update Posted (Actual): June 15, 2023
• Last Update Submitted That Met QC Criteria: June 7, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Periodontitis; Periodontal Pocket
• Other Study ID Numbers: Ozone gel in periodontitis

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No