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NCT Number: NCT02066337

Effect of Ozone Gel on Treatment of Chronic Periodontitis

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.

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Key information

Conditions

Periodontal Diseases Chronic Disease Chronic Periodontitis Disease Attributes Mouth Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Periodontitis Stomatognathic Diseases

Age range

30 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

October 6 University

Cairo, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Scaling and Root Planing

Procedure

Placebo Gel

Drug

Ozonated olive oil gel

Drug

Other names: Ozonated olive oil gel = Oxactiv gel

Primary outcomes

  1. 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.

Secondary outcomes

  1. Plaque Index

    Time frame: 6 months

    plaque index was recorded at baseline and at 1, 3 and 6 months post treatment.

  2. Gingival index

    Time frame: 6 months

    Gingival index was recorded at base line,1,3,6 months post treatment

  3. Probing pocket depth

    Time frame: 6 months

    Probing pocket depth was recorded at base line, 1, 3, 6 months post treatment

  4. Clinical attachment level

    Time frame: 6 months

    Clinical attachment level was recorded at baseline, 1, 3 and 6 months post treatment

  5. 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

Sponsors and collaborators

Lead sponsor

October 6 University

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Feb 19, 2014
Registry last updated
Feb 20, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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