Use of Ozone Gel as an Antimicrobial in Treatment of Periodontitis

NCT05905445 | Completed Phase 1

• 1 other identifier: Ozone gel in periodontitis
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

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.

Conditions

Periodontal Pocket; Periodontitis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• plaque index

  baseline to one and three months

• bleeding on probing

  baseline to one and three months

• clinical attachment loss

  baseline to one and three months

• level of platelet-activating factor in gingival crevicular fluid

  baseline to one and three months

Study Arms (2)

ozone gel with conventional scaling and root planning

EXPERIMENTAL

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 conventional scaling and root planning

NO INTERVENTION

only scaling and root planning without any intervention.

Interventions

ozone gel DRUG

the activity of omega-3 in the ozone gel may be advantageous as a host-modulating agent in the supplemental treatment of periodontitis

ozone gel with conventional scaling and root planning

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ghufran Falih Hassan: lead

Study Sites (1)

Ghufran Falih Hassen

Baghdad, Iraq

Location

Related 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.

  PMID: 34356480 BACKGROUND

MeSH Terms

Conditions

Periodontal Pocket; Periodontitis

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: postgraduate student

Study Record Dates

• First Submitted: May 26, 2023
• First Posted: June 15, 2023
• Study Start: March 9, 2022
• Primary Completion: September 9, 2022
• Study Completion: September 9, 2022
• Last Updated: June 15, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

IR (1)