Clinical trial NCT05905445: Use of Ozone Gel as an Antimicrobial in Treatment of Periodontitis
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Periodontal Pocket
Periodontitis
Lead sponsor: University of Baghdad
Sponsor class: OTHER
First posted: 2023-06-15
Enrollment: 21
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: probing pocket depth
timeFrame: baseline to one and three months
Secondary outcomes:
measure: plaque index
timeFrame: baseline to one and three months
measure: bleeding on probing
timeFrame: baseline to one and three months
measure: clinical attachment loss
timeFrame: baseline to one and three months
measure: level of platelet-activating factor in gingival crevicular fluid
timeFrame: baseline to one and three months
Other outcomes:
Locations:
city: Baghdad
country: Iraq
facility: Ghufran Falih Hassen
Study officials:
References:
citation: 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.