PeriodontitisNCT06366295
Comparison of Subgingival Mechanotherapy With and Without the Use of a Perioscope: Clinical Trial
A study testing subgingival mechanotherapy with perioscopy and classical subgingival mechanotherapy in people with Periodontitis, run by Medical University of Warsaw at 1 site in Poland.
Trial summary
The study aims to comparatively assess clinical parameters, biochemical and microbiological parameters after treatment of periodontitis using subgingival mechanotherapy traditional and subgingival mechanotherapy using a perioscope. Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Periodontitis
- What is being tested?
- subgingival mechanotherapy with perioscopy and classical subgingival mechanotherapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 sitePoland
- Study dates
- 1 Jun 2023to 31 Jan 2026
- 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 20 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- age 20-60; (II)
- preserved lateral and anterior teeth;
- no periodontal treatment in the last 12 months;
- intermediate or advanced periodontitis (Stage II / III / IV)
- in each quadrant at least three teeth with PPD>5 mm after initial treatment (scaling, motivation, instruction)
Who cannot join
- antibiotic therapy in the last 6 months;
- smoking;
- systemic diseases affecting periodontal tissues;
- pregnancy or lactation;
- orthodontic treatment;
- tooth mobility II / III degree;
- involvement of third degree furcations according to Hamp classification;
- endodontic issues
Trial locations and contacts
1 site in 1 country.
Poland1 site
Department of Periodontology and Oral Mucosa Diseases, Medical University of Warsaw
Warsaw, Masovian Voivodeship, 02-097
About this study
Official title: Subgingival Mechanotherapy Using a Periodontal Endoscope Compared to Classical Subgingival Mechanotherapy for the Treatment of Periodontitis: a Randomized Clinical Trial
The study aims to comparatively assess clinical parameters, biochemical and microbiological parameters after treatment of periodontitis using subgingival mechanotherapy traditional and subgingival mechanotherapy using a perioscope.
Read the detailed description
Non-surgical treatment is the basic form of disease treatment periodontitis. Its first stage is the mechanical removal of dental plaque along with the control of risk factors. Subgingival mechanotherapy, also known as scaling and root planing (SRP) is the next stage, aimed at the subgingival area. Perioscopy makes possible direct real-time visualization of the root surface during the procedure. The research results published so far indicate improvement or no significant differences clinical parameters after SRP procedure using a perioscope vs traditional subgingival instrumentation. The aim of this study is to indicate, or not, clinical, biochemical (level of pro-inflammatory cytokines) and microbiological (A. actinomycetemcomitans, P. gingivalis, T. denticola) differences after periodontitis treatment using the traditional method vs. using a perioscope.
- Conditions
- Periodontitis
- Being tested
- subgingival mechanotherapy with perioscopy, classical subgingival mechanotherapy
- Keywords
- periodontal endoscopy, perioscopy
- Medical subject headings
- Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
subgingival mechanotherapy with perioscopyDevice
Subgingival mechanotherapy using a machine scaler, curettes and a perioscope
classical subgingival mechanotherapyDevice
Subgingival mechanotherapy using a machine scaler and curettes
| Study group | Role | What they receive |
|---|---|---|
| Subgingival mechanotherapy with perioscopy | Experimental | Scaling and root planing using ultrasonic scaler and curettes, under the control of a perioscope, enabling real-time, magnified imaging of the root surface. Receives: Device: subgingival mechanotherapy with perioscopy |
| Classical subgingival mechanotherapy | Active comparator | Scaling and root planing using ultrasonic scaler and curettes. Receives: Device: classical subgingival mechanotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Probing pocket depth (PPD)
Distance from the gingival margin to the bottom of the gingival sulcus
Measured: 0 (before), 3 and 6 months after SRP
Clinical attachment level (CAL)
Distance from the cementoenamel junction to the bottom of the gingival sulcus
Measured: 0 (before), 3 and 6 months after SRP
Bleeding on probing (BoP)
Percentage of sites with bleeding provoked by applying a probe to the bottom of a sulcus/pocket.
Measured: 0 (before), 3 and 6 months after SRP
Plaque index (PI)
Percentage of sites with plaque
Measured: 0 (before), 3 and 6 months after SRP
Secondary outcomes (2)
Width of keratinized tissue (KTW)
Distance between the most apical point of gingival margin and the mucogingival junction
Measured: 0 (before), 3 and 6 months after SRP
Gingival thickness (GT)
Thickness of the gingiva measured 2 mm apical to the gingival margin
Measured: 0 (before), 3 and 6 months after SRP
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2024
- Study start1 Jun 2023
- Primary completion31 Jan 2026
- Study completion31 Jan 2026
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.
- More trials run by Medical University of WarsawThe 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
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Warsaw
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bartlomiej Górski, PhD, Principal investigator, Department of Periodontology and Oral Mucosa Diseases, Medical University of Warsaw
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06366295
- Sponsor's protocol ID
- WUM.Perio.05
- Status last verified
- Jun 2023
- First submitted
- 10 Apr 2024
- Last updated
- 24 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Subgingival Mechanotherapy Using a Periodontal Endoscope Compared to Classical Subgingival Mechanotherapy for the Treatment of Periodontitis: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06366295
- Acronym / sponsor ID
- WUM.Perio.05
- Conditions
- Periodontitis
- Keywords
- periodontal endoscopy, perioscopy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Medical University of WarsawUniversity, hospital or other
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 31 Jan 2026 (actual)
- Study completion
- 31 Jan 2026 (actual)
- First posted
- 15 Apr 2024 (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 study aims to comparatively assess clinical parameters, biochemical and microbiological parameters after treatment of periodontitis using subgingival mechanotherapy traditional and subgingival mechanotherapy using a perioscope.
Detailed description
Non-surgical treatment is the basic form of disease treatment periodontitis. Its first stage is the mechanical removal of dental plaque along with the control of risk factors. Subgingival mechanotherapy, also known as scaling and root planing (SRP) is the next stage, aimed at the subgingival area. Perioscopy makes possible direct real-time visualization of the root surface during the procedure. The research results published so far indicate improvement or no significant differences clinical parameters after SRP procedure using a perioscope vs traditional subgingival instrumentation. The aim of this study is to indicate, or not, clinical, biochemical (level of pro-inflammatory cytokines) and microbiological (A. actinomycetemcomitans, P. gingivalis, T. denticola) differences after periodontitis treatment using the traditional method vs. using a perioscope.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Subgingival mechanotherapy with perioscopy | Experimental | Device: subgingival mechanotherapy with perioscopyScaling and root planing using ultrasonic scaler and curettes, under the control of a perioscope, enabling real-time, magnified imaging of the root surface. |
| Classical subgingival mechanotherapy | Active comparator | Device: classical subgingival mechanotherapyScaling and root planing using ultrasonic scaler and curettes. |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- age 20-60; (II)
- preserved lateral and anterior teeth;
- no periodontal treatment in the last 12 months;
- intermediate or advanced periodontitis (Stage II / III / IV)
- in each quadrant at least three teeth with PPD>5 mm after initial treatment (scaling, motivation, instruction)
Key exclusion criteria (8 listed)
- antibiotic therapy in the last 6 months;
- smoking;
- systemic diseases affecting periodontal tissues;
- pregnancy or lactation;
- orthodontic treatment;
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 |
|---|---|---|
| subgingival mechanotherapy with perioscopySubgingival mechanotherapy using a machine scaler, curettes and a perioscope | Device | Subgingival mechanotherapy with perioscopy |
| classical subgingival mechanotherapySubgingival mechanotherapy using a machine scaler and curettes | Device | Classical subgingival mechanotherapy |
Primary outcome
Probing pocket depth (PPD)
Time frame: 0 (before), 3 and 6 months after SRP
Distance from the gingival margin to the bottom of the gingival sulcus
Clinical attachment level (CAL)
Time frame: 0 (before), 3 and 6 months after SRP
Distance from the cementoenamel junction to the bottom of the gingival sulcus
Bleeding on probing (BoP)
Time frame: 0 (before), 3 and 6 months after SRP
Percentage of sites with bleeding provoked by applying a probe to the bottom of a sulcus/pocket.
Plaque index (PI)
Time frame: 0 (before), 3 and 6 months after SRP
Percentage of sites with plaque
2 secondary outcomes
Width of keratinized tissue (KTW)
Time frame: 0 (before), 3 and 6 months after SRP
Gingival thickness (GT)
Time frame: 0 (before), 3 and 6 months after SRP
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 24 Jul 2026.
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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.
Bartlomiej Górski, PhD principal investigator
Department of Periodontology and Oral Mucosa Diseases, Medical University of Warsaw
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing subgingival mechanotherapy with perioscopy and classical subgingival mechanotherapy in people with Periodontitis, run by Medical University of Warsaw at 1 site 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 5 inclusion and 8 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 24 Jul 2026. 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 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.
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 (PPD) (time frame: 0 (before), 3 and 6 months after SRP). The study lists 4 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 24 Jul 2026.