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

Phase 2

• Conditions: Periodontitis
• Interventions: Procedure: scaling root planing; Drug: new local drug delivery

• Registration Number: NCT04862819
• Lead Sponsor: Wroclaw Medical University

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.

Study Timeline

• Status Verified: 2021-01
• Study Start: 2021-01-02
• Study First Submitted: 2021-03-02
• Study First Submitted QC: 2021-04-22
• Last Update Submitted: 2021-04-22
• Study First Posted: 2021-04-28
• Last Update Posted: 2021-04-28
• Primary Completion: 2021-11-01
• Study Completion: 2021-12-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
scaling root planning	scaling root planing	patients in this group will have a scaling root planing procedure only
scaling root planning with new local drug delivery	new local drug delivery	patients in this group will have a scaling root planing procedure and a drug administered
scaling root planning with new local drug delivery	scaling root planing	patients in this group will have a scaling root planing procedure and a drug administered

Primary Outcome Measures

Name	Time	Method
changes in PD (pocket depth in millimetres )	3 month	Change in depth of periodontal pockets measured from the bottom of the pocket to the edge of the gum in millimetres using periodontal probe
changes in microbiome (rt PCR test)	3 month	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)
changes in CAL (clinical attachment level in millimetres )	3 month	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

Trial Locations

Locations (2)

Jacek Zborowski; 🇵🇱 Wrocław, Dolnoslaskie, Poland

Wroclaw Medical University; 🇵🇱 Wrocław, Poland