Evaluation of a New Local Drug Delivery in the Nonsurgical Treatment of Periodontitis

NCT ID: NCT04862819

Last Updated: 2021-04-28

Study Results

Results pending

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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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-02

Study Completion Date

2021-12-30

Brief Summary

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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.

Detailed Description

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Clinical trials will be conducted on 60 patients of the Department of Periodontology of the Medical University of Wrocław with 3rd or 4th degree generalized periodontitis, who will consent to participate in the research by signing the documentation approved by the Bioethics Committee of our University. The exclusion criteria will be: the 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 and age over 65 years. The research will be carried out according to the scheme of parallel randomization and double-blinded trial in two groups of 30 people. All qualified patients will undergo an initial period of periodontal treatment and scaling / root planning.

In the first group, on one side of the dental arch, the drug under evaluation will be used, and on the other side, placebo with a change of side in every second patient. In the other group, the drug under evaluation or placebo will be used on one side, and the SRP treatment with alternation of sides on the other side for every second patient.

Conditions

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Periodontitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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scaling root planning

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

Group Type ACTIVE_COMPARATOR

scaling root planing

Intervention Type PROCEDURE

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

scaling root planning with new local drug delivery

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

Group Type EXPERIMENTAL

new local drug delivery

Intervention Type DRUG

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

scaling root planing

Intervention Type PROCEDURE

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

Interventions

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new local drug delivery

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

Intervention Type DRUG

scaling root planing

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

Intervention Type PROCEDURE

Other Intervention Names

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New LDD Scaling root planing (gold standard treatment)

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* 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
Minimum Eligible Age

25 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Wroclaw Medical University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Małgorzata Szulc, phd

Role: STUDY_DIRECTOR

wroclaw medical univeristy

Tomasz Konopka, prof

Role: PRINCIPAL_INVESTIGATOR

wroclaw medical univeristy

Locations

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Jacek Zborowski

Wroclaw, Lower Silesian Voivodeship, Poland

Site Status RECRUITING

Wroclaw Medical University

Wroclaw, , Poland

Site Status ENROLLING_BY_INVITATION

Countries

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Poland

Central Contacts

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jacek zborowski, phd

Role: CONTACT

0048668446828

Facility Contacts

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jacek zborowski, phd

Role: primary

Other Identifiers

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KB776-2019

Identifier Type: -

Identifier Source: org_study_id

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