Effect of Ozone Gel on Treatment of Chronic Periodontitis

February 19, 2014 updated by: Enas Elgendy, October 6 University

Effect of Ozone Gel on Alveolar Bone Density and Superoxide Dismutase in Chronic Periodontitis: A Randomized Controlled Clinical Study

To evaluate the efficacy of locally delivered ozone gel as an adjunct to conventional periodontal therapy on selected clinical parameters as well as alveolar bone density (BD) and superoxide dismutase (SOD) activity in patient with chronic periodontitis.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

In this study, the investigators tested the effect of ozone gel as a local delivery system in treatment of chronic periodontitis in term of probing pocket depth reduction, mean gain in clinical attachment level, a more rise in BD values as well as greater reduction in SOD activity compared to scaling and root planing (SRP) alone.

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt
        • October 6 University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

28 years to 58 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. The participant's age ranged between 30 and 60 years.
  2. All of the patients suffered from chronic periodontitis with attachment loss ≥ 5mm.
  3. Willingness to participate and sign the informed consent.

Exclusion Criteria:

  1. Any systemic disease that affect the periodontium.
  2. Pregnancy, lactation, postmenopausal women
  3. People who take anti-inflammatory drugs, antibiotics or vitamins within the previous 3 month.
  4. People who use mouth washes regularly
  5. Heavy smoking (> 10 cigarettes/day)
  6. History of alcohol abuse.
  7. Participation in other clinical trials.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: placebo gel
scaling and root planing with placebo gel
Procedure: scaling and root planing
Drug: placebo gel
Active Comparator: Ozonated olive oil gel
scaling and root planing with Ozonated olive oil gel
Procedure: scaling and root planing
Drug: Ozonated olive oil gel
Other Names:
  • Ozonated olive oil gel = Oxactiv gel

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Superoxide dismutase activity
Time Frame: 6 months
Superoxide dismutase activity in the gingival crevicular fluid was carried out at baseline, 1, 3 and 6 months post treatment.
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Plaque Index
Time Frame: 6 months
plaque index was recorded at baseline and at 1, 3 and 6 months post treatment.
6 months
Gingival index
Time Frame: 6 months
Gingival index was recorded at base line,1,3,6 months post treatment
6 months
Probing pocket depth
Time Frame: 6 months
Probing pocket depth was recorded at base line, 1, 3, 6 months post treatment
6 months
Clinical attachment level
Time Frame: 6 months
Clinical attachment level was recorded at baseline, 1, 3 and 6 months post treatment
6 months
Bone density
Time Frame: 6 months
Bone density was carried out using Digora software (Digora system, Soredex, Orion Corp., Finland) at baseline and 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

October 6 University

Investigators

  • Principal Investigator: Enas Elgendy, ph.D, October 6 University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2013

Primary Completion (Actual)

January 1, 2014

Study Completion (Actual)

February 1, 2014

Study Registration Dates

First Submitted

January 30, 2014

First Submitted That Met QC Criteria

February 14, 2014

First Posted (Estimate)

February 19, 2014

Study Record Updates

Last Update Posted (Estimate)

February 20, 2014

Last Update Submitted That Met QC Criteria

February 19, 2014

Last Verified

February 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • mn1965

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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