Porous Metronidazole Loaded Matrix for Local Treatment of Periodontitis.

Wroclaw Medical University

Status and phase: Unknown; Phase 4

Conditions: Chronic Periodontitis

Treatments: Drug: Metronidazole

Study type: Interventional

Funder types: Other

Identifiers

NCT03791099

KB 98/2016

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: All

Ages: 35 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• non-smokers
• suffering from chronic periodontitis

Exclusion criteria

• any antibiotics taken systematically or locally in the preceding six months

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

Metronidazole

Experimental group

Description:

19,8 mg of metronidazole in one polymer matrix

Treatment:

Drug: Metronidazole

Only SRP

No Intervention group

Description:

standard non-surgical treatment- scaling/root planing