A Phase 1 interventional study of ozone gel in Periodontal Pocket and Periodontitis, sponsored by Ghufran Falih Hassan. Completed at 1 site in Iraq. Per ClinicalTrials.gov, last updated 2023-06-15.
Sponsored by Ghufran Falih Hassan · Phase 1, Interventional, and Treatment
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.
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.
1,635 studies on the registry are indexed under Periodontitis; 327 are open to participants now.
This study's enrollment of 21 is below the median of 45 across 1,191 interventional studies indexed under Periodontitis.
Browse Periodontitis studies →This is the only study on the registry with Ghufran Falih Hassan as lead sponsor.
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Exclusion Criteria:
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
only scaling and root planning without any intervention.
the activity of omega-3 in the ozone gel may be advantageous as a host-modulating agent in the supplemental treatment of periodontitis
probing pocket depth
change of probing pocket depth by ozone gel as an adjunct to non-surgical treatment
Time frame: baseline to one and three months
plaque index
change in presence plaque (used disclosing agent) by ozone gel as an adjunct to non-surgical treatment
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: baseline to one and three months
Plan to share: No
This study is completed, as verified in Jun 2023. You cannot join it, but the record below documents what was studied.
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