Use of Ozone Gel as an Antimicrobial in Treatment of Periodontitis

Periodontitis Clinical Trial

Official 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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05905445
• Other study ID #: Ozone gel in periodontitis
• Status: Completed
• Phase: Phase 1
• Start date: March 9, 2022
• Est. completion date: September 9, 2022

Study information

• Verified date: June 2023
• Source: University of Baghdad
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: September 9, 2022
• Est. primary completion date: September 9, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Periodontal Pocket
• Periodontitis

Intervention

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

Locations

Country	Name	City	State
Iraq	Ghufran Falih Hassen	Baghdad

Sponsors (1)

Lead Sponsor	Collaborator
Ghufran Falih Hassan

Country where clinical trial is conducted

Iraq, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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