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Chronic PeriodontitisPhase 4NCT03791099

Porous Metronidazole Loaded Matrix for Local Treatment of Periodontitis.

A Phase 4 study testing Metronidazole in people with Chronic Periodontitis, run by Wroclaw Medical University at 1 site in Poland.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 35 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Chronic Periodontitis
What is being tested?
Metronidazole
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 sitePoland
Study dates
23 Apr 2018to Apr 2019
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 35 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • non-smokers
  • suffering from chronic periodontitis

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Poland1 site

  • Wroclaw Medical University

    Wroclaw, 50-425

Other trials in Poland

About this study

Official title: Preparation and Analysis of Material, Biological and Clinical Parameters of Metronidazole-loaded Porous Matrices for Local Periodontitis Treatment

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.

Read more

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.

Being tested
Metronidazole
Keywords
Periodontitis treatment, Periodonal pockets, local delivery drugs
Medical subject headings
Chronic Periodontitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MetronidazoleDrug

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

Study groups in NCT03791099
Study groupRoleWhat they receive
MetronidazoleExperimental19,8 mg of metronidazole in one polymer matrix
Receives: Drug: Metronidazole
Only SRPNo interventionstandard non-surgical treatment- scaling/root planing

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. PD

    Periodontal pocket depth

    Measured: 4 weeks after the first visit

  2. API

    Approximal Plaque Index

    Measured: 4 weeks after the first visit

  3. BoP

    Bleeding of probing

    Measured: 4 weeks after the first visit

  4. PBI

    Papilla bleeding index

    Measured: 4 weeks after the first visit

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Jan 2019
  2. Study start23 Apr 2018
  3. Primary completionJan 2019 (estimated)
  4. Study completionApr 2019 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03791099
Sponsor's protocol ID
KB 98/2016
Status last verified
Jan 2019
First submitted
29 Dec 2018
Last updated
4 Jan 2019
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 23853452

  • 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.

    PubMed 26373225

  • 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.

    PubMed 25750745

  • 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.

    PubMed 23827565

  • 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.

    PubMed 26289672

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Metronidazole in people with Chronic Periodontitis, run by Wroclaw Medical University at 1 site in Poland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 4 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

PD (time frame: 4 weeks after the first visit). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03791099, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jan 2019.

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