NCT03791099

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Apr 2018

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 23, 2018

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

December 29, 2018

Completed
3 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 2, 2019

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2019

Completed
Last Updated

January 4, 2019

Status Verified

January 1, 2019

Enrollment Period

8 months

First QC Date

December 29, 2018

Last Update Submit

January 2, 2019

Conditions

Chronic Periodontitis

Keywords

Periodontitis treatmentPeriodonal pocketslocal delivery drugs

Outcome Measures

Primary Outcomes (4)

  • 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

Study Arms (2)

Metronidazole

EXPERIMENTAL

19,8 mg of metronidazole in one polymer matrix

Drug: Metronidazole

Only SRP

NO INTERVENTION

standard non-surgical treatment- scaling/root planing

Interventions

MetronidazoleDRUG

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

Metronidazole

Eligibility Criteria

Age35 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • non-smokers
  • suffering from chronic periodontitis

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wroclaw Medical University

Wroclaw, 50-425, Poland

Location

Related Publications (5)

  • 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.

    PMID: 23853452BACKGROUND

  • 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.

    PMID: 26373225BACKGROUND

  • 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.

    PMID: 25750745BACKGROUND

  • 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.

    PMID: 23827565BACKGROUND

  • 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.

    PMID: 26289672BACKGROUND

MeSH Terms

Conditions

Chronic Periodontitis

Interventions

Metronidazole

Condition Hierarchy (Ancestors)

PeriodontitisPeriodontal DiseasesMouth DiseasesStomatognathic DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

NitroimidazolesNitro CompoundsOrganic ChemicalsImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Marek Ziętek, Prof

    Department of Periodontology, Wroclaw Medical University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor in Periodontology Department

Study Record Dates

First Submitted

December 29, 2018

First Posted

January 2, 2019

Study Start

April 23, 2018

Primary Completion

January 1, 2019

Study Completion

April 1, 2019

Last Updated

January 4, 2019

Record last verified: 2019-01

Locations

PL(1)