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Use of Ozone Gel as an Antimicrobial in Treatment of Periodontitis

Primary Purpose

Periodontal Pocket, Periodontitis

Status
Completed
Phase
Phase 1
Locations
Iraq
Study Type
Interventional
Intervention
ozone gel
Sponsored by
Ghufran Falih Hassan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Periodontal Pocket

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Ghufran Falih Hassen

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

ozone gel with conventional scaling and root planning

only conventional scaling and root planning

Arm Description

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

only scaling and root planning without any intervention.

Outcomes

Primary Outcome Measures

probing pocket depth
change of probing pocket depth by ozone gel as an adjunct to non-surgical treatment

Secondary Outcome Measures

plaque index
change in presence plaque (used disclosing agent) by ozone gel as an adjunct to non-surgical treatment
bleeding on probing
change in presence bleeding on probing (used UNC 15 probe) by ozone gel as an adjunct to non-surgical treatment
clinical attachment loss
change in presence clinical attachment loss (Used relative attachment stent) by ozone gel as an adjunct to non-surgical treatment
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

Full Information

First Posted
May 26, 2023
Last Updated
June 7, 2023
Sponsor
Ghufran Falih Hassan
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1. Study Identification

Unique Protocol Identification Number
NCT05905445
Brief Title
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

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
March 9, 2022 (Actual)
Primary Completion Date
September 9, 2022 (Actual)
Study Completion Date
September 9, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Ghufran Falih Hassan

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Periodontal Pocket, Periodontitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
21 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ozone gel with conventional scaling and root planning
Arm Type
Experimental
Arm Description
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
Arm Title
only conventional scaling and root planning
Arm Type
No Intervention
Arm Description
only scaling and root planning without any intervention.
Intervention Type
Drug
Intervention Name(s)
ozone gel
Intervention Description
the activity of omega-3 in the ozone gel may be advantageous as a host-modulating agent in the supplemental treatment of periodontitis
Primary Outcome Measure Information:
Title
probing pocket depth
Description
change of probing pocket depth by ozone gel as an adjunct to non-surgical treatment
Time Frame
baseline to one and three months
Secondary Outcome Measure Information:
Title
plaque index
Description
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
Title
bleeding on probing
Description
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
Title
clinical attachment loss
Description
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
Title
level of platelet-activating factor in gingival crevicular fluid
Description
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

10. Eligibility

Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Facility Information:
Facility Name
Ghufran Falih Hassen
City
Baghdad
Country
Iraq

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34356480
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.
Results Reference
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Use of Ozone Gel as an Antimicrobial in Treatment of Periodontitis

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