Ozone Gel Application in Controlled Type 2 Diabetic Patients With Periodontitis

Study Overview
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Brief Summary
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The adjunctive topical subgingival application ozone gel creates a great improvements in the clinical, bacteriological and immunological parameters over the gold standard of periodontal pocket treatment alone.

Detailed Description
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The aim of this study is to compare the effect of using ozone gel as a locally delivered adjunct to scaling and root planning versus scaling and root planning alone on the clinical parameters in stageIII grade B in periodontitis patients with controlled diabetic patients.

Official Title
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Clinical and Radiographic Evaluation of Non-Surgical Therapy With and Without Ozone Gel Application in Controlled Type 2 Diabetic Patients With Periodontitis

Conditions
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Periodontal Diseases

Intervention / Treatment
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* Drug: Ozone gel


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient with controlled diabetic type II. (HgA1C <7) (Mori et al., 2021) Adult patients above 18 years old. Patients with stage III and grade B periodontitis. Patients accept 3-months follow-up period (cooperative patients). Patients provide an informed consent Exclusion Criteria: 1. Presence of prosthetic crowns. 2. Extensive restorations. 3. Periodontal therapy within the last 12 months. 4. Having surgical therapy or undergoing orthodontic treatment. 5. Ongoing drug therapy that might have an impact on the clinical signs and symptoms of periodontitis. 6. The use of antibiotics or anti-inflammatory drugs 1 month prior to the procedure and till the end of 3 months of follow-up. 7. Smokers. 8. Pregnant females. 9. Any known allergies

Ages Eligible for Study
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Minimum Age: 18 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
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: intervention<br>Ozone gel | Drug: Ozone gel<br>* application of Ozone gel after scaling by ultrasonic scaler in the bottom of periodontal pocket<br>* Other names: GeliO3,Bioemmei Srl,36100 Vicenza ,Italy;|
| Active Comparator: active comparator<br>nonsurgical periodontal treatment(scaling) | Drug: Ozone gel<br>* application of Ozone gel after scaling by ultrasonic scaler in the bottom of periodontal pocket<br>* Other names: GeliO3,Bioemmei Srl,36100 Vicenza ,Italy;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Attachment Level | clinical attachment gain by using UNC15 Periodontal probe/ numerical data | 3months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Probing Depth | measuring probing depth by using UNC15 Periodontal probe/numerical data | 3 months | 
| plaque index | measuring it visually/numerical data | 3 months | 
| Dentinal Hypersensitivity | measuring it using VAS scale | 7 days | 
| Bleeding on Probing visually/numerical data | measuring it visually/numerical data | 3 months |