Use of Ozone Gel as an Antimicrobial in Treatment of Periodontitis

NCT ID: NCT05905445

Last Updated: 2023-06-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 21 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-03-09
• Study Completion Date: 2022-09-09

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.

Conditions

Periodontal Pocket; Periodontitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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

Group Type: EXPERIMENTAL

ozone gel

Intervention Type: DRUG

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

only conventional scaling and root planning

only scaling and root planning without any intervention.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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

Intervention Type: DRUG

Eligibility Criteria

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Ghufran Falih Hassan

OTHER

Sponsor Role: lead

Responsible Party

Ghufran Falih Hassan

postgraduate student

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Ghufran Falih Hassen

Baghdad, , Iraq

Countries

Iraq

References

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.

Reference Type: BACKGROUND

PMID: 34356480 (View on PubMed)

Other Identifiers

Ozone gel in periodontitis

Identifier Type: -

Identifier Source: org_study_id