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

Wroclaw Medical University

Status and phase: Unknown; Phase 2

Conditions: Periodontitis

Treatments: Drug: new local drug delivery; Procedure: scaling root planing

Study type: Interventional

Funder types: Other

Identifiers

NCT04862819

KB776-2019

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 25 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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60 participants in 2 patient groups

scaling root planning

Active Comparator group

Description:

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

Treatment:

Procedure: scaling root planing

scaling root planning with new local drug delivery

Experimental group

Description:

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

Treatment:

Procedure: scaling root planing

Drug: new local drug delivery