Effect of Ozone Gel on Treatment of Chronic Periodontitis

Study Overview
=================
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.

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

Conditions
-----------------
Periodontal Diseases

Intervention / Treatment
-----------------
* Procedure: scaling and root planing
* Drug: placebo gel
* Drug: Ozonated olive oil gel


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 60 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: placebo gel<br>scaling and root planing with placebo gel | Procedure: scaling and root planing<br> <br> Drug: placebo gel<br> <br> |
| Active Comparator: Ozonated olive oil gel<br>scaling and root planing with Ozonated olive oil gel | Procedure: scaling and root planing<br> <br> Drug: Ozonated olive oil gel<br> <br> * 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 | 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 | plaque index was recorded at baseline and at 1, 3 and 6 months post treatment. | 6 months | 
| Gingival index | Gingival index was recorded at base line,1,3,6 months post treatment | 6 months | 
| Probing pocket depth | Probing pocket depth was recorded at base line, 1, 3, 6 months post treatment | 6 months | 
| Clinical attachment level | Clinical attachment level was recorded at baseline, 1, 3 and 6 months post treatment | 6 months | 
| Bone density | Bone density was carried out using Digora software (Digora system, Soredex, Orion Corp., Finland) at baseline and 6 months | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Ozone gel, Antioxidants, Chronic periodontitis, Superoxide dismutase