PeriodontitisNCT06127069
Treatment of Residual Pockets in Periodontal Patients Using an Oscillating Chitosan Device
A study testing chitosan brush and ultrasonic scaler in people with Periodontitis, run by Aristotle University Of Thessaloniki at 1 site in Greece.
Trial summary
The aim of the current study was to investigate the effect of a chitosan brush on the treatment of residual pockets in patients already treated for periodontal disease. Thirty-six patients with chronic periodontitis (Stage ΙΙΙ, ΙV) that had already completed causative therapy and exhibited at least two residual… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Periodontitis
- What is being tested?
- chitosan brush and ultrasonic scaler
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteGreece
- Study dates
- 8 Sep 2021to 29 Nov 2022
- Phase
- Interventional
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects aged 18 or over
- Subjects diagnosed with chronic periodontitis, Stage III or IV, and had received full mouth scaling and root planning at least three months prior to baseline examination
- Subjects with at least two residual periodontal pockets of at least 5mm depth that bled on probing
- Full mouth plaques scores ≤20%
Who cannot join
- Subjects that had received antibiotic therapy 6 months prior to initial examination
- Subjects with compromised systemic conditions
- Patients undergoing chemotherapy or radiotherapy
- Pregnant or lactating women
Trial locations and contacts
1 site in 1 country.
Greece1 site
Department of Periodontology, School of Dentistry, Aristotle University of Thessaloniki
Thessaloniki
About this study
Official title: Treatment of Residual Pockets in Periodontal Patients Using an Oscillating Chitosan Device - A Randomized Parallel Arm Clinical Trial
The aim of the current study was to investigate the effect of a chitosan brush on the treatment of residual pockets in patients already treated for periodontal disease. Thirty-six patients with chronic periodontitis (Stage ΙΙΙ, ΙV) that had already completed causative therapy and exhibited at least two residual periodontal pockets ≥ 5mm that bled on probing, were randomly assigned to two groups. In the test group debridement of residual pockets was performed with ultrasonic scaler and the chitosan brush, whereas in the control group only ultrasonic scalers were used.
- Conditions
- Periodontitis
- Being tested
- chitosan brush, ultrasonic scaler
- Keywords
- residual pockets, chitosan, treatment of periodontitis
- Medical subject headings
- Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
chitosan brushDevice
Also called Labrida BioClean
debridement of periodontal pockets with ultrasonic scaler first and after with chitosan brush for 2 minutes
ultrasonic scalerDevice
debridement of periodontal pockets only with ultrasonic scaler
| Study group | Role | What they receive |
|---|---|---|
| chitosan group | Experimental | debridement of residual periodontal pockets with ultrasonic scaler and the chitosan brush Receives: Device: chitosan brush; Device: ultrasonic scaler |
| control group | Active comparator | debridement of residual periodontal pockets with ultrasonic scaler only Receives: Device: ultrasonic scaler |
What is being measured
The primary outcome is the main question the study is designed to answer.
Probing Pocket Depth
the distance from the mucosa margin to the bottom of the periodontal pocket
Measured: baseline, 6 weeks, 3 months, 6 months
MMP-8
levels of matrix metalloproteinase -8 in gingival crevicular fluid
Measured: baseline, 6 weeks, 3 months, 6 months
Secondary outcomes (3)
Bleeding on Probing
presence or absence of bleeding after probe insertion in the periodontal pocket
Measured: baseline, 6 weeks, 3 months, 6 months
Clinical Attachment Level
the distance from cementoenamel junction to the bottom of periodontal pocket
Measured: baseline, 6 weeks, 3 months, 6 months
Gingival Recession
the distance from cementoenamel junction to the mucosa margin
Measured: baseline, 6 weeks, 3 months, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2023
- Study start8 Sep 2021
- Primary completion29 Nov 2022
- Study completion29 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PeriodontitisStudies of the same condition, open and under way.
- More trials run by Aristotle University Of ThessalonikiThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomized parallel arm clinical trial
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aristotle University Of Thessaloniki
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Georgia Tseleki, Aristotle University Of Thessaloniki
- Investigators
- Lazaros Tsalikis, Study chair, Department of Periodontology, School of Dentistry, Aristotle University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06127069
- Sponsor's protocol ID
- 14/07/2021, 129
- Status last verified
- Nov 2023
- First submitted
- 7 Nov 2023
- Last updated
- 18 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Tseleki G, Batas L, Davidopoulou S, Wohlfahrt JC, Menexes G, Tsalikis L. Management of residual periodontal pockets using an oscillating chitosan device: A randomized clinical trial. J Periodontol. 2026 Apr;97(4):685-696. doi: 10.1002/jper.70010. Epub 2025 Nov 7.
PubMed 41201882
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Residual Pockets in Periodontal Patients Using an Oscillating Chitosan Device - A Randomized Parallel Arm Clinical Trial
- ClinicalTrials.gov ID
- NCT06127069
- Acronym / sponsor ID
- 14/07/2021, 129
- Conditions
- Periodontitis
- Keywords
- residual pockets, chitosan, treatment of periodontitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Aristotle University Of ThessalonikiUniversity, hospital or other
- Study start
- 8 Sep 2021 (actual)
- Primary completion
- 29 Nov 2022 (actual)
- Study completion
- 29 Nov 2022 (actual)
- First posted
- 13 Nov 2023 (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 current study was to investigate the effect of a chitosan brush on the treatment of residual pockets in patients already treated for periodontal disease. Thirty-six patients with chronic periodontitis (Stage ΙΙΙ, ΙV) that had already completed causative therapy and exhibited at least two residual periodontal pockets ≥ 5mm that bled on probing, were randomly assigned to two groups. In the test group debridement of residual pockets was performed with ultrasonic scaler and the chitosan brush, whereas in the control group only ultrasonic scalers were used.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- randomized parallel arm clinical trial
| Arm | Type | Receives |
|---|---|---|
| chitosan group | Experimental | Device: chitosan brush, Device: ultrasonic scalerdebridement of residual periodontal pockets with ultrasonic scaler and the chitosan brush |
| control group | Active comparator | Device: ultrasonic scalerdebridement of residual periodontal pockets with ultrasonic scaler only |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Subjects aged 18 or over
- Subjects diagnosed with chronic periodontitis, Stage III or IV, and had received full mouth scaling and root planning at least three months prior to baseline examination
- Subjects with at least two residual periodontal pockets of at least 5mm depth that bled on probing
- Full mouth plaques scores ≤20%
Key exclusion criteria (4 listed)
- Subjects that had received antibiotic therapy 6 months prior to initial examination
- Subjects with compromised systemic conditions
- Patients undergoing chemotherapy or radiotherapy
- Pregnant or lactating women
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 |
|---|---|---|
| chitosan brushAlso: Labrida BioCleandebridement of periodontal pockets with ultrasonic scaler first and after with chitosan brush for 2 minutes | Device | chitosan group |
| ultrasonic scalerdebridement of periodontal pockets only with ultrasonic scaler | Device | chitosan group, control group |
Primary outcome
Probing Pocket Depth
Time frame: baseline, 6 weeks, 3 months, 6 months
the distance from the mucosa margin to the bottom of the periodontal pocket
MMP-8
Time frame: baseline, 6 weeks, 3 months, 6 months
levels of matrix metalloproteinase -8 in gingival crevicular fluid
3 secondary outcomes
Bleeding on Probing
Time frame: baseline, 6 weeks, 3 months, 6 months
Clinical Attachment Level
Time frame: baseline, 6 weeks, 3 months, 6 months
Gingival Recession
Time frame: baseline, 6 weeks, 3 months, 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2023.
- Derived from this study: PubMed 41201882Tseleki G, Batas L, Davidopoulou S, Wohlfahrt JC, Menexes G, Tsalikis L. Management of residual periodontal pockets using an oscillating chitosan device: A randomized clinical trial. J Periodontol. 2026 Apr;97(4):685-696. doi: 10.1002/jper.70010. Epub 2025 Nov 7.
- 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.
Lazaros Tsalikis study chair
Department of Periodontology, School of Dentistry, Aristotle University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing chitosan brush and ultrasonic scaler in people with Periodontitis, run by Aristotle University Of Thessaloniki at 1 site in Greece.
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 4 inclusion and 4 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: finished, as of the sponsor's last update on 18 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Probing Pocket Depth (time frame: baseline, 6 weeks, 3 months, 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06127069, which also lists 1 linked publication.
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 18 Nov 2023.