PeriodontitisPhase 2NCT04862819
Evaluation of a New Local Drug Delivery in the Nonsurgical Treatment of Periodontitis
A Phase 2 study testing new local drug delivery and scaling root planing in people with Periodontitis, run by Wroclaw Medical University at 2 sites in Poland.
Trial 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… Read more about this study
- Who is it for?
- Ages 25 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Periodontitis
- What is being tested?
- new local drug delivery and scaling root planing
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesPoland
- Study dates
- 2 Jan 2021to 30 Dec 2021
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- stage- 3rd degree generalized periodontitis
- stage 4th degree generalized periodontitis
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Poland2 sites, 2 recruiting
- Recruiting
Jacek Zborowski
Wroclaw, Lower Silesian Voivodeship, 52-311
jacek zborowski, phd, jacekzborowski@gmail.com
- Enrolling by invitation
Wroclaw Medical University
Wroclaw, 52129
About this study
Official title: 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.
Read the 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.
- Conditions
- Periodontitis
- Being tested
- new local drug delivery, scaling root planing
- Medical subject headings
- Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
new local drug deliveryDrug
Also called New LDD
In the first group, on one side of the dental arch, the drug under evaluation will be used, and on the other side srp
scaling root planingProcedure or surgery
Also called Scaling root planing (gold standard treatment)
In the second group, on one side of the dental arch srp will be performed
| Study group | Role | What they receive |
|---|---|---|
| scaling root planning | Active comparator | patients in this group will have a scaling root planing procedure only Receives: Procedure: scaling root planing |
| scaling root planning with new local drug delivery | Experimental | patients in this group will have a scaling root planing procedure and a drug administered Receives: Drug: new local drug delivery; Procedure: scaling root planing |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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)
Measured: 3 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2021
- Study start2 Jan 2021
- Primary completion1 Nov 2021 (estimated)
- Study completion30 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PeriodontitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wroclaw Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Małgorzata Szulc, phd, Study director, wroclaw medical univeristyTomasz Konopka, prof, Principal investigator, wroclaw medical univeristy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04862819
- Sponsor's protocol ID
- KB776-2019
- Status last verified
- Jan 2021
- First submitted
- 2 Mar 2021
- Last updated
- 28 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical, Biochemical and Microbiological Evaluation of a New Local Drug Delivery in the Nonsurgical Treatment of Periodontitis
- ClinicalTrials.gov ID
- NCT04862819
- Acronym / sponsor ID
- KB776-2019
- Conditions
- Periodontitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Wroclaw Medical UniversityUniversity, hospital or other
- Study start
- 2 Jan 2021 (actual)
- Primary completion
- 1 Nov 2021 (estimated)
- Study completion
- 30 Dec 2021 (estimated)
- First posted
- 28 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| scaling root planning | Active comparator | Procedure: scaling root planingpatients in this group will have a scaling root planing procedure only |
| scaling root planning with new local drug delivery | Experimental | Drug: new local drug delivery, Procedure: scaling root planingpatients in this group will have a scaling root planing procedure and a drug administered |
Who may qualify
- Ages
- 25 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- stage- 3rd degree generalized periodontitis
- stage 4th degree generalized periodontitis
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| new local drug deliveryAlso: New LDDIn the first group, on one side of the dental arch, the drug under evaluation will be used, and on the other side srp | Drug | scaling root planning with new local drug delivery |
| scaling root planingAlso: Scaling root planing (gold standard treatment)In the second group, on one side of the dental arch srp will be performed | Procedure or surgery | scaling root planning, scaling root planning with new local drug delivery |
Primary outcome
changes in PD (pocket depth in millimetres )
Time frame: 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 CAL (clinical attachment level in millimetres )
Time frame: 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
changes in microbiome (rt PCR test)
Time frame: 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)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Małgorzata Szulc, phd study director
wroclaw medical univeristy
Tomasz Konopka, prof principal investigator
wroclaw medical univeristy
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing new local drug delivery and scaling root planing in people with Periodontitis, run by Wroclaw Medical University at 2 sites in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact jacek zborowski, phd (0048668446828, jacek.zborowski@umed.wroc.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
changes in PD (pocket depth in millimetres ) (time frame: 3 month). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2021.