Effect of Ozone Oil After Non-surgical Periodontal Treatment

Study Overview
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Brief Summary
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The goal of this clinical trial is to evaluate the use of ozone oil as an adjunctive of non-surgical periodontal treatment (NSPT) on diabetics type 2 patients (DM2) compared to control group with chronic periodontal disease. The principal question is to evaluate if the ozone oil could improve periodontal clinical parameters. Thirty-two sites of 16 diabetics type 2 patients (DM2) with moderate to advanced periodontal disease containing two sites with periodontal pocket depth (PPD) of > 5 mm were selected. The treatment was distributed in 2 groups in the split mouth design: Control- scaling and root planing + saline solution (control) and Test - scaling and root planning + ozone oil

Official Title
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Effect of Ozone Oil After Non-surgical Periodontal Treatment

Conditions
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Periodontal Diseases

Intervention / Treatment
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* Drug: test
* Drug: Control


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Periodontitis Systemic type 2 diabetes Exclusion Criteria: Hypersensitivity to ozone oil Osteoporosis types I and II Alcoholism Immunosuppressio Pregnant and lactating Physical/emotional stress drugs Use of antibiotics, anti-inflammatories and hormone Oral candidiasis Received periodontal treatment in the last six months prior to the procedure

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: This is a prospective clinical randomized controlled, split mouth designed, doble blinded study.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Control<br>Scaling and root planing + saline solution gel (control) will be adminster at probing depth > 5mm. | Drug: Control<br>* saline solution 0.09% used as an adjunctive as scaling and root planing<br>* Other names: Placebo Control;|
| Active Comparator: Test<br>Scaling and root planing + Ozone Oil will be adminster at probing depth > 5mm. | Drug: test<br>* Ozone oil used as an adjunctive of scaling and root planing and control,<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plaque Index | Percentage | baseline | 
| Gingival Index | Percentage | baseline | 
| Probing Depth | mm | baseline | 
| clinical attachment level | mm | baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plaque Index | Percentage | 3 months | 
| Gingival Index | Percentage | 3 months | 
| Probing Depth | mm | 3 months | 
| clinical attachment levels | mm | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Periodontitis, Periodontal treatment, diabetes