NCT04862819

Brief Summary

The aim of the planned randomized clinical trial will be the clinical and microbiological evaluation of the new intracellular drug developed in cooperation with the Chair and Department of Drug Form Technology of the Medical University and the Department and Department of Pharmaceutical Microbiology and Parasitology of the Medical University in Wrocław.

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
60

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jan 2021

Shorter than P25 for phase_2

Geographic Reach
1 country

2 active sites

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

January 2, 2021

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 2, 2021

Completed
2 months until next milestone

First Posted

Study publicly available on registry

April 28, 2021

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2021

Completed
Last Updated

April 28, 2021

Status Verified

January 1, 2021

Enrollment Period

10 months

First QC Date

March 2, 2021

Last Update Submit

April 22, 2021

Conditions

Periodontitis

Outcome Measures

Primary Outcomes (3)

  • changes in PD (pocket depth in millimetres )

    Change in depth of periodontal pockets measured from the bottom of the pocket to the edge of the gum in millimetres using periodontal probe

    3 month

  • changes in CAL (clinical attachment level in millimetres )

    Change in clinical attachment level of periodontal pockets measured from the Cement-enamel junction to the bottom of the pocket in millimetres using periodontal probe

    3 month

  • changes in microbiome (rt PCR test)

    change in microbiological and biochemical parameters of pocket microbiome using PCR real time test 3 months after Local dryg delivery (LDD) application( taken from the gingival pocket with gingival fluid with a paper filter. There will be six bacterial strains and the bacterial total load assessed)

    3 month

Study Arms (2)

scaling root planning

ACTIVE COMPARATOR

patients in this group will have a scaling root planing procedure only

Procedure: scaling root planing

scaling root planning with new local drug delivery

EXPERIMENTAL

patients in this group will have a scaling root planing procedure and a drug administered

Drug: new local drug deliveryProcedure: scaling root planing

Interventions

new local drug deliveryDRUG

In the first group, on one side of the dental arch, the drug under evaluation will be used, and on the other side srp

Also known as: New LDD
scaling root planning with new local drug delivery
scaling root planingPROCEDURE

In the second group, on one side of the dental arch srp will be performed

Also known as: Scaling root planing (gold standard treatment)
scaling root planningscaling root planning with new local drug delivery

Eligibility Criteria

Age25 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • stage- 3rd degree generalized periodontitis
  • stage 4th degree generalized periodontitis

You may not qualify if:

  • presence of general diseases affecting the clinical condition of the periodontium,
  • hypersensitivity to the drug used in the carrier system,
  • lack of proper oral hygiene
  • active nicotinism
  • age over 65 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Jacek Zborowski

Wroclaw, Lower Silesian Voivodeship, 52-311, Poland

RECRUITING

Wroclaw Medical University

Wroclaw, 52129, Poland

ENROLLING BY INVITATION

MeSH Terms

Conditions

Periodontitis

Condition Hierarchy (Ancestors)

Periodontal DiseasesMouth DiseasesStomatognathic Diseases

Study Officials

  • Małgorzata Szulc, phd

    wroclaw medical univeristy

    STUDY DIRECTOR

  • Tomasz Konopka, prof

    wroclaw medical univeristy

    PRINCIPAL INVESTIGATOR

Central Study Contacts

jacek zborowski, phd

CONTACT

0048668446828jacek.zborowski@umed.wroc.pl

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 2, 2021

First Posted

April 28, 2021

Study Start

January 2, 2021

Primary Completion

November 1, 2021

Study Completion

December 30, 2021

Last Updated

April 28, 2021

Record last verified: 2021-01

Data Sharing

IPD Sharing
Will not share

Locations

PL(2)