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

Periodontitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04862819
• Other study ID #: KB776-2019
• Status: Recruiting
• Phase: Phase 2
• Start date: January 2, 2021
• Est. completion date: December 30, 2021

Study information

• Verified date: January 2021
• Source: Wroclaw Medical University
• Contact: jacek zborowski, phd
• Phone: 0048668446828
• Email: jacek.zborowski[@]umed.wroc.pl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 30, 2021
• Est. primary completion date: November 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 25 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Periodontitis

Intervention

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

Locations

Country	Name	City	State
Poland	Jacek Zborowski	Wroclaw	Dolnoslaskie
Poland	Wroclaw Medical University	Wroclaw

Sponsors (1)

Lead Sponsor	Collaborator
Wroclaw Medical University

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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