Evaluation of a New Local Drug Delivery in the Nonsurgical Treatment of Periodontitis
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Periodontitis
- Type
- Interventional
- Phase
- Phase 2
- Design
- Allocation: RandomizedIntervention Model: Crossover AssignmentMasking: Single (Investigator)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 25 years and 65 years
- Gender
- Both males and females
Description
Clinical trials will be conducted on 60 patients of the Department of Periodontology of the Medical University of Wroc?aw 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 Universi...
Clinical trials will be conducted on 60 patients of the Department of Periodontology of the Medical University of Wroc?aw 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.
Tracking Information
- NCT #
- NCT04862819
- Collaborators
- Not Provided
- Investigators
- Study Director: Ma?gorzata Szulc, phd wroclaw medical univeristy Principal Investigator: Tomasz Konopka, prof wroclaw medical univeristy