Porous Metronidazole Loaded Matrix for Local Treatment of Periodontitis.

Study Overview
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Brief Summary
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Aim of the study is the efficiency assessment of porous Metronidazole loaded matrix based on gelatin/hydroxyethylcellulose blend in treatment of deep periodontal pockets resulting from severe chronic periodontitis. The matrix was invented and produced in Department of Drug Form Technology, Wroclaw Medical University. The porous metronidazole (MTZ) loaded matrix was fabricated by the freeze-drying technique. The morphology, mechanical properties, in vitro degradation, MTZ release from dried sponge were evaluated and also the clinical trials were performed. Patients suffering from chronic periodontitis are examined. To evaluate oral hygiene API (Approximal Plaque Index) and the gum inflammation BOP (Bleeding on Probing) and PBI (Papilla Bleeding Index) indices are used. The clinical examination is performed 3 times. On the first visit the output indicators are defined. The subgingival scaling is performed and Metronidazol on porous matrix is applied to the selected periodontal pockets. 2 control tests of periodontal indices are carried out after one week and one month from the application. In the control group after scaling/root planing procedure, there is no application of metronidazole.

Official Title
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Preparation and Analysis of Material, Biological and Clinical Parameters of Metronidazole-loaded Porous Matrices for Local Periodontitis Treatment

Conditions
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Chronic Periodontitis

Intervention / Treatment
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* Drug: Metronidazole


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: non-smokers suffering from chronic periodontitis Exclusion Criteria: any antibiotics taken systematically or locally in the preceding six months

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 65 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: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Metronidazole<br>19,8 mg of metronidazole in one polymer matrix | Drug: Metronidazole<br>* After subgingival ultrasonic scaling is performed, metronidazole in polymer matrix is applied to the selected periodontal pockets.<br>|
| No Intervention: Only SRP<br>standard non-surgical treatment- scaling/root planing | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PD | Periodontal pocket depth | 4 weeks after the first visit | 
| API | Approximal Plaque Index | 4 weeks after the first visit | 
| BoP | Bleeding of probing | 4 weeks after the first visit | 
| PBI | Papilla bleeding index | 4 weeks after the first visit | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Periodontitis treatment, Periodonal pockets, local delivery drugs