Clinical trial NCT03791099: Porous Metronidazole Loaded Matrix for Local Treatment of Periodontitis.
Official title: Preparation and Analysis of Material, Biological and Clinical Parameters of Metronidazole-loaded Porous Matrices for Local Periodontitis Treatment
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Chronic Periodontitis
Keywords: Periodontitis treatment
Periodonal pockets
local delivery drugs
Lead sponsor: Wroclaw Medical University
Sponsor class: OTHER
First posted: 2019-01-02
Enrollment: 40
Sex: ALL
Minimum age (years): 35
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: Inclusion Criteria:

* non-smokers
* suffering from chronic periodontitis

Exclusion Criteria:

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

Primary outcomes:
measure: PD
timeFrame: 4 weeks after the first visit
measure: API
timeFrame: 4 weeks after the first visit
measure: BoP
timeFrame: 4 weeks after the first visit
measure: PBI
timeFrame: 4 weeks after the first visit
Secondary outcomes:
Other outcomes:
Locations:
city: Wroclaw
country: Poland
facility: Wroclaw Medical University
Study officials:
affiliation: Department of Periodontology, Wroclaw Medical University
name: Marek Ziętek, Prof
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.