Effect of Ozone Gel on Treatment of Chronic Periodontitis

Phase 2

Completed

• Conditions: Periodontal Diseases
• Interventions: Procedure: scaling and root planing; Drug: Ozonated olive oil gel; Drug: placebo gel

• Registration Number: NCT02066337
• Lead Sponsor: October 6 University

Brief 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.

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 Timeline

• Study Start: 2013-03
• Primary Completion: 2014-01
• Study First Submitted: 2014-01-30
• Status Verified: 2014-02
• Study Completion: 2014-02
• Study First Submitted QC: 2014-02-14
• Study First Posted: 2014-02-19
• Last Update Submitted: 2014-02-19
• Last Update Posted: 2014-02-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ozonated olive oil gel	scaling and root planing	scaling and root planing with Ozonated olive oil gel
placebo gel	scaling and root planing	scaling and root planing with placebo gel
Ozonated olive oil gel	Ozonated olive oil gel	scaling and root planing with Ozonated olive oil gel
placebo gel	placebo gel	scaling and root planing with placebo gel

Primary Outcome Measures

Name	Time	Method
Superoxide dismutase activity	6 months	Superoxide dismutase activity in the gingival crevicular fluid was carried out at baseline, 1, 3 and 6 months post treatment.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

October 6 University; 🇪🇬 Cairo, Egypt