Clinical trial NCT04862819: Evaluation of a New Local Drug Delivery in the Nonsurgical Treatment of Periodontitis
Official title: Clinical, Biochemical and Microbiological Evaluation of a New Local Drug Delivery in the Nonsurgical Treatment of Periodontitis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Periodontitis
Lead sponsor: Wroclaw Medical University
Sponsor class: OTHER
First posted: 2021-04-28
Enrollment: 60
Sex: ALL
Minimum age (years): 25
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: changes in PD (pocket depth in millimetres )
timeFrame: 3 month
measure: changes in CAL (clinical attachment level in millimetres )
timeFrame: 3 month
measure: changes in microbiome (rt PCR test)
timeFrame: 3 month
Secondary outcomes:
Other outcomes:
Locations:
city: Wrocław
country: Poland
facility: Jacek Zborowski
state: Dolnoslaskie
city: Wrocław
country: Poland
facility: Wroclaw Medical University
Study officials:
affiliation: wroclaw medical univeristy
name: Małgorzata Szulc, phd
role: STUDY_DIRECTOR
affiliation: wroclaw medical univeristy
name: Tomasz Konopka, prof
role: PRINCIPAL_INVESTIGATOR
References: