Effect of Ozone Gel on Treatment of Chronic Periodontitis

Periodontal Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02066337
• Other study ID #: mn1965
• Status: Completed
• Phase: Phase 2
• First received: January 30, 2014
• Last updated: February 19, 2014
• Start date: March 2013
• Est. completion date: February 2014

Study information

• Verified date: February 2014
• Source: October 6 University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Egypt: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: February 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 30 Years to 60 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Periodontitis
• Gingival Diseases
• Periodontal Diseases
• Periodontitis

Intervention

Procedure:
• scaling and root planing

Drug:
• placebo gel

• Ozonated olive oil gel

Locations

Country	Name	City	State
Egypt	October 6 University	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
October 6 University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Superoxide dismutase activity	Superoxide dismutase activity in the gingival crevicular fluid was carried out at baseline, 1, 3 and 6 months post treatment.	6 months	Yes
Secondary	Plaque Index	plaque index was recorded at baseline and at 1, 3 and 6 months post treatment.	6 months	Yes
Secondary	Gingival index	Gingival index was recorded at base line,1,3,6 months post treatment	6 months	Yes
Secondary	Probing pocket depth	Probing pocket depth was recorded at base line, 1, 3, 6 months post treatment	6 months	Yes
Secondary	Clinical attachment level	Clinical attachment level was recorded at baseline, 1, 3 and 6 months post treatment	6 months	Yes
Secondary	Bone density	Bone density was carried out using Digora software (Digora system, Soredex, Orion Corp., Finland) at baseline and 6 months	6 months	Yes