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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Periodontitis

Intervention / Treatment
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* Drug: new local drug delivery
* Procedure: scaling root planing


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: scaling root planning<br>patients in this group will have a scaling root planing procedure only | Procedure: scaling root planing<br>* In the second group, on one side of the dental arch srp will be performed<br>* Other names: Scaling root planing (gold standard treatment);|
| Experimental: scaling root planning with new local drug delivery<br>patients in this group will have a scaling root planing procedure and a drug administered | Drug: new local drug delivery<br>* In the first group, on one side of the dental arch, the drug under evaluation will be used, and on the other side srp<br>* Other names: New LDD;Procedure: scaling root planing<br>* In the second group, on one side of the dental arch srp will be performed<br>* Other names: Scaling root planing (gold standard treatment);|

What is the study measuring?
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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 |