NCT04862819

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

Clinical, Biochemical and Microbiological Evaluation of a New Local Drug Delivery in the Nonsurgical Treatment of Periodontitis

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Wroclaw Medical University · Academic / Other
• Sex: All
• Age: 25 Years – 65 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Periodontitis

Interventions

Type	Name	Description
DRUG	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
PROCEDURE	scaling root planing	In the second group, on one side of the dental arch srp will be performed

Timeline

• Start date: 2021-01-02
• Primary completion: 2021-11-01
• Completion: 2021-12-30
• First posted: 2021-04-28
• Last updated: 2021-04-28

Locations

2 sites across 1 country: Poland