MedTrace Logo

Porous Metronidazole Loaded Matrix for Local Treatment of Periodontitis.

NCT03791099 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2019-01-04

No results posted yet for this study

Summary

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.

Conditions

  • Chronic Periodontitis

Interventions

DRUG

Metronidazole

After subgingival ultrasonic scaling is performed, metronidazole in polymer matrix is applied to the selected periodontal pockets.

Sponsors & Collaborators

  • Wroclaw Medical University

    lead OTHER

Principal Investigators

  • Marek Ziętek, Prof · Department of Periodontology, Wroclaw Medical University

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
35 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-04-23
Primary Completion
2019-01-31
Completion
2019-04-30

Countries

  • Poland

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03791099 on ClinicalTrials.gov