Porous Metronidazole Loaded Matrix for Local Treatment of Periodontitis.
NCT ID: NCT03791099
Last Updated: 2019-01-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
40 participants
INTERVENTIONAL
2018-04-23
2019-04-30
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Metronidazole
19,8 mg of metronidazole in one polymer matrix
Metronidazole
After subgingival ultrasonic scaling is performed, metronidazole in polymer matrix is applied to the selected periodontal pockets.
Only SRP
standard non-surgical treatment- scaling/root planing
No interventions assigned to this group
Interventions
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Metronidazole
After subgingival ultrasonic scaling is performed, metronidazole in polymer matrix is applied to the selected periodontal pockets.
Eligibility Criteria
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Inclusion Criteria
* suffering from chronic periodontitis
Exclusion Criteria
35 Years
65 Years
ALL
Yes
Sponsors
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Wroclaw Medical University
OTHER
Responsible Party
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Malgorzata Szulc
Assistant Professor in Periodontology Department
Principal Investigators
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Marek Ziętek, Prof
Role: STUDY_CHAIR
Department of Periodontology, Wroclaw Medical University
Locations
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Wroclaw Medical University
Wroclaw, , Poland
Countries
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References
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Pandit N, Dahiya R, Gupta R, Bali D, Kathuria A. Comparative evaluation of locally delivered minocycline and metronidazole in the treatment of periodontitis. Contemp Clin Dent. 2013 Jan;4(1):48-53. doi: 10.4103/0976-237X.111615.
Da Rocha HA, Silva CF, Santiago FL, Martins LG, Dias PC, De Magalhaes D. Local Drug Delivery Systems in the Treatment of Periodontitis: A Literature Review. J Int Acad Periodontol. 2015 Jul;17(3):82-90.
Ahmed EM. Hydrogel: Preparation, characterization, and applications: A review. J Adv Res. 2015 Mar;6(2):105-21. doi: 10.1016/j.jare.2013.07.006. Epub 2013 Jul 18.
Gautam S, Dinda AK, Mishra NC. Fabrication and characterization of PCL/gelatin composite nanofibrous scaffold for tissue engineering applications by electrospinning method. Mater Sci Eng C Mater Biol Appl. 2013 Apr 1;33(3):1228-35. doi: 10.1016/j.msec.2012.12.015. Epub 2012 Dec 8.
Pachuau L. Recent developments in novel drug delivery systems for wound healing. Expert Opin Drug Deliv. 2015;12(12):1895-909. doi: 10.1517/17425247.2015.1070143. Epub 2015 Aug 4.
Other Identifiers
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KB 98/2016
Identifier Type: -
Identifier Source: org_study_id
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