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

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.

Study Overview

• Status: Unknown
• Conditions: Periodontitis
• Intervention / Treatment: Procedure: scaling root planing; Drug: new local drug delivery

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 Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Phase 2

Contacts and Locations

Study Locations

• Poland
  • Wrocław, Poland, 52129
    • Enrolling by invitation
    • Wroclaw Medical University
  • Dolnoslaskie
    • Wrocław, Dolnoslaskie, Poland, 52-311
      • Recruiting
      • Jacek Zborowski
      • Contact: jacek zborowski, phd; Email: jacekzborowski@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: scaling root planning; patients in this group will have a scaling root planing procedure only	Procedure: scaling root planing; In the second group, on one side of the dental arch srp will be performed; Other Names: Scaling root planing (gold standard treatment)
Experimental: scaling root planning with new local drug delivery; patients in this group will have a scaling root planing procedure and a drug administered	Procedure: scaling root planing; In the second group, on one side of the dental arch srp will be performed; Other Names: Scaling root planing (gold standard treatment); 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; Other Names: New LDD

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: Wroclaw Medical University
• Investigators: Study Director: Małgorzata Szulc, phd, Wroclaw Medical Univeristy; Principal Investigator: Tomasz Konopka, prof, Wroclaw Medical Univeristy

Study record dates

Study Major Dates

• Study Start (Actual): January 2, 2021
• Primary Completion (Anticipated): November 1, 2021
• Study Completion (Anticipated): December 30, 2021

Study Registration Dates

• First Submitted: March 2, 2021
• First Submitted That Met QC Criteria: April 22, 2021
• First Posted (Actual): April 28, 2021

Study Record Updates

• Last Update Posted (Actual): April 28, 2021
• Last Update Submitted That Met QC Criteria: April 22, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Periodontitis
• Other Study ID Numbers: KB776-2019

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No