Use of Ozone Gel as an Antimicrobial in Treatment of Periodontitis

Sponsor
Ghufran Falih Hassan (Other)
Overall Status
Completed
CT.gov ID
NCT05905445
Collaborator
(none)
21
1
2
6
3.5

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: ozone gel
Phase 1

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
21 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Treatment
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.
Actual Study Start Date :
Mar 9, 2022
Actual Primary Completion Date :
Sep 9, 2022
Actual Study Completion Date :
Sep 9, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: 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

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

No Intervention: only conventional scaling and root planning

only scaling and root planning without any intervention.

Outcome Measures

Primary Outcome Measures

  1. probing pocket depth [baseline to one and three months]

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

Secondary Outcome Measures

  1. plaque index [baseline to one and three months]

    change in presence plaque (used disclosing agent) by ozone gel as an adjunct to non-surgical treatment

  2. bleeding on probing [baseline to one and three months]

    change in presence bleeding on probing (used UNC 15 probe) by ozone gel as an adjunct to non-surgical treatment

  3. clinical attachment loss [baseline to one and three months]

    change in presence clinical attachment loss (Used relative attachment stent) by ozone gel as an adjunct to non-surgical treatment

  4. level of platelet-activating factor in gingival crevicular fluid [baseline to one and three months]

    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

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Ghufran Falih Hassen Baghdad Iraq

Sponsors and Collaborators

  • Ghufran Falih Hassan

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Ghufran Falih Hassan, postgraduate student, University of Baghdad
ClinicalTrials.gov Identifier:
NCT05905445
Other Study ID Numbers:
  • Ozone gel in periodontitis
First Posted:
Jun 15, 2023
Last Update Posted:
Jun 15, 2023
Last Verified:
Jun 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 15, 2023