Periodontal DiseaseNCT07469813
Non-Surgical Periodontal Treatment With an Oscillating Ultrasonic Device With Adjunctive Root Polishing. A Randomized, Comparative, Prospective Clinical Trial.
A study testing Non-surgical periodontal treatment with U/S scalers and hand instruments and Periodontal treatment with U/S scalers and Vector/Paro in people with Periodontal Disease, run by 251 Hellenic Air Force & VA General Hospital at 1 site in Greece.
Trial summary
Non-surgical periodontal treatment leads to periodontal inflammation resolution and amelioration of the clinical periodontal indices via the microbial load reduction. Additionally, non-surgical periodontal treatment can be performed with different instruments. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Periodontal Disease
- What is being tested?
- Non-surgical periodontal treatment with U/S scalers and hand instruments and Periodontal treatment with U/S scalers and Vector/Paro
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteGreece
- Study dates
- 20 Jun 2025to 20 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Systematically healthy adults
- Signed informed consent
- Periodontal disease diagnosis
- Absence of periodontal treatment the previous 12 months
Who cannot join
- Medical history that interferes with the healing process (CVD, organ transplantation, renal or hepatic failure etc)
- Antibiotic and anti-inflammatory intake up to 1 month before treatment initiation
- Pharmaceutically induced gingival enlargement
- Pregnancy/ lactation
Trial locations and contacts
1 site in 1 country.
About this study
Non-surgical periodontal treatment leads to periodontal inflammation resolution and amelioration of the clinical periodontal indices via the microbial load reduction. Additionally, non-surgical periodontal treatment can be performed with different instruments. Ultrasonic scalers with or without hand scalers are more frequently used during Phase I periodontal treatment, however the one who performs the treatment is committed to choose the tools that according to his judgment will lead to the best clinical outcomes following non-surgical periodontal therapy. The aim of this study was to evaluate the effectiveness of non-surgical periodontal treatment with a new oscillating ultrasonic device (Paro) with adjunctive root polishing versus traditional scaling and root planing with ultrasonic device and hand instruments, 3 and 6 months after treatment, at patients diagnosed with chronic periodontitis stage II, III and IV.
Read the detailed description
Non-surgical periodontal treatment leads to periodontal inflammation resolution and amelioration of the clinical periodontal indices via the microbial load reduction. Additionally, non-surgical periodontal treatment can be performed with different instruments. Ultrasonic scalers with or without hand scalers are more frequently used during Phase I periodontal treatment, however the one who performs the treatment is committed to choose the tools that according to his judgment will lead to the best clinical outcomes following non-surgical periodontal therapy. The aim of this study was to evaluate the effectiveness of non-surgical periodontal treatment with a new oscillating ultrasonic device (Paro) with adjunctive root polishing versus traditional scaling and root planing with ultrasonic device and hand instruments, 3 and 6 months after treatment, at patients diagnosed with chronic periodontitis stage II, III and IV.
- Conditions
- Periodontal Disease
- Being tested
- Non-surgical periodontal treatment with U/S scalers and hand instruments, Periodontal treatment with U/S scalers and Vector/Paro
- Keywords
- periodontal disease, oscillating, hand instruments, periodontal treatment
- Medical subject headings
- Periodontal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-surgical periodontal treatment with U/S scalers and hand instrumentsProcedure or surgery
Treatment of Group 1 was performed with U/S scalers (P3 \& P1), hand instruments( Gracey curettes) and sub-gingival polishing.
Periodontal treatment with U/S scalers and Vector/ParoProcedure or surgery
Treatment of Group 2 was performed with U/S scalers (P3 \& P1), Vector-Paro System and sub- gingival polishing. In both groups, completion was decided upon the feeling of the operator that the root surfaces are smooth enough.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Active comparator | Conventional Periodontal Treatment, scaling and root planing with ultrasonic device and hand instruments Receives: Procedure: Non-surgical periodontal treatment with U/S scalers and hand instruments |
| Group 2 | Experimental | Periodontal treatment with Vector/Paro Receives: Procedure: Periodontal treatment with U/S scalers and Vector/Paro |
What is being measured
The primary outcome is the main question the study is designed to answer.
Probing Pocket Depth
Measurement from Free Gingival Margin to the base of the sulcus/pocket, in millimeters
Measured: From enrollment to the end of post-treatment monitoring at 6 months
Secondary outcomes (5)
Clinical Attachment Levels
DIstance from cementoenamel junction to the base of sulcus/pocket, in millimeters
Measured: From enrollment to the end of post-treatment monitoring at 6 months
Bleeding on probing
Presence/Absence of bleeding on probing
Measured: From enrollment to the end of post-treatment monitoring at 6 months
Root Dentin Hypersensitivity
Feeling of sensitivity to cold stimuli measured with VAS scale
Measured: From enrollment to the end of post-treatment monitoring at 6 months
Pain perception after treatment
Feeling of pain after treatmetn measured in VAS scale
Measured: From enrollment to the end of post-treatment monitoring at 6 months
Recession
Distance from cemento-enamel junction to the free gingival margin in millimeters
Measured: From enrollment to the end of post-treatment monitoring at 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 Mar 2026
- Study start20 Jun 2025
- Primary completion20 Jan 2026
- Study completion20 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Periodontal DiseaseStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Systematically healthy adults with a periodontal disease diagnosis, but absence of any periodontal treatment in the previous 12 months were chosen. At baseline, patient's demographics were recorded together with a medical and dental history report and a panoramic X- ray was performed. Oral hygiene instructions were given individually. The clinical measurements concerning the periodontal tissues were fully recorded in a Florida Probe periodontal chart pre-therapeutically and 3 to 6 months after treatment. Subsequently, all patients received non-surgical periodontal treatment with the novel vertically oscillating ultrasonic device (Vector/Paro,Durr Dental) with adjunctive subgingival root air-polishing(Lunos Perio Combi trehalose powder).
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- 251 Hellenic Air Force & VA General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Panagiotis Theodorelos, DDS, MSc, Principal investigator, 251 Hellenic Airforce Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07469813
- Sponsor's protocol ID
- F076730153562/16625/251HAF/IRP
- Status last verified
- Mar 2026
- First submitted
- 10 Mar 2026
- Last updated
- 13 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-Surgical Periodontal Treatment With an Oscillating Ultrasonic Device With Adjunctive Root Polishing. A Randomized, Comparative, Prospective Clinical Trial.
- ClinicalTrials.gov ID
- NCT07469813
- Acronym / sponsor ID
- F076730153562/16625/251HAF/IRP
- Conditions
- Periodontal Disease
- Keywords
- periodontal disease, oscillating, hand instruments, periodontal treatment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- 251 Hellenic Air Force & VA General HospitalUniversity, hospital or other
- Study start
- 20 Jun 2025 (actual)
- Primary completion
- 20 Jan 2026 (actual)
- Study completion
- 20 Jan 2026 (actual)
- First posted
- 13 Mar 2026 (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.
Non-surgical periodontal treatment leads to periodontal inflammation resolution and amelioration of the clinical periodontal indices via the microbial load reduction. Additionally, non-surgical periodontal treatment can be performed with different instruments. Ultrasonic scalers with or without hand scalers are more frequently used during Phase I periodontal treatment, however the one who performs the treatment is committed to choose the tools that according to his judgment will lead to the best clinical outcomes following non-surgical periodontal therapy. The aim of this study was to evaluate the effectiveness of non-surgical periodontal treatment with a new oscillating ultrasonic device (Paro) with adjunctive root polishing versus traditional scaling and root planing with ultrasonic device and hand instruments, 3 and 6 months after treatment, at patients diagnosed with chronic periodontitis stage II, III and IV.
Detailed description
Non-surgical periodontal treatment leads to periodontal inflammation resolution and amelioration of the clinical periodontal indices via the microbial load reduction. Additionally, non-surgical periodontal treatment can be performed with different instruments. Ultrasonic scalers with or without hand scalers are more frequently used during Phase I periodontal treatment, however the one who performs the treatment is committed to choose the tools that according to his judgment will lead to the best clinical outcomes following non-surgical periodontal therapy. The aim of this study was to evaluate the effectiveness of non-surgical periodontal treatment with a new oscillating ultrasonic device (Paro) with adjunctive root polishing versus traditional scaling and root planing with ultrasonic device and hand instruments, 3 and 6 months after treatment, at patients diagnosed with chronic periodontitis stage II, III and IV.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Systematically healthy adults with a periodontal disease diagnosis, but absence of any periodontal treatment in the previous 12 months were chosen. At baseline, patient's demographics were recorded together with a medical and dental history report and a panoramic X- ray was performed. Oral hygiene instructions were given individually. The clinical measurements concerning the periodontal tissues were fully recorded in a Florida Probe periodontal chart pre-therapeutically and 3 to 6 months after treatment. Subsequently, all patients received non-surgical periodontal treatment with the novel vertically oscillating ultrasonic device (Vector/Paro,Durr Dental) with adjunctive subgingival root air-polishing(Lunos Perio Combi trehalose powder).
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Active comparator | Procedure: Non-surgical periodontal treatment with U/S scalers and hand instrumentsConventional Periodontal Treatment, scaling and root planing with ultrasonic device and hand instruments |
| Group 2 | Experimental | Procedure: Periodontal treatment with U/S scalers and Vector/ParoPeriodontal treatment with Vector/Paro |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Systematically healthy adults
- Signed informed consent
- Periodontal disease diagnosis
- Absence of periodontal treatment the previous 12 months
Key exclusion criteria (4 listed)
- Medical history that interferes with the healing process (CVD, organ transplantation, renal or hepatic failure etc)
- Antibiotic and anti-inflammatory intake up to 1 month before treatment initiation
- Pharmaceutically induced gingival enlargement
- Pregnancy/ lactation
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 |
|---|---|---|
| Non-surgical periodontal treatment with U/S scalers and hand instrumentsTreatment of Group 1 was performed with U/S scalers (P3 \& P1), hand instruments( Gracey curettes) and sub-gingival polishing. | Procedure or surgery | Group 1 |
| Periodontal treatment with U/S scalers and Vector/ParoTreatment of Group 2 was performed with U/S scalers (P3 \& P1), Vector-Paro System and sub- gingival polishing. In both groups, completion was decided upon the feeling of the operator that the root surfaces are smooth enough. | Procedure or surgery | Group 2 |
Primary outcome
Probing Pocket Depth
Time frame: From enrollment to the end of post-treatment monitoring at 6 months
Measurement from Free Gingival Margin to the base of the sulcus/pocket, in millimeters
5 secondary outcomes
Clinical Attachment Levels
Time frame: From enrollment to the end of post-treatment monitoring at 6 months
Bleeding on probing
Time frame: From enrollment to the end of post-treatment monitoring at 6 months
Root Dentin Hypersensitivity
Time frame: From enrollment to the end of post-treatment monitoring at 6 months
Pain perception after treatment
Time frame: From enrollment to the end of post-treatment monitoring at 6 months
Recession
Time frame: From enrollment to the end of post-treatment monitoring at 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 13 Mar 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Periodontal Disease
Not yet recruitingObservational study
Periodontal Status and Biomarkers in MASLD
Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)
Recruiting
Thermosensitive Hyaluronic Gel With Octenidine as an Adjunctive to Subgingival Instrumentation
Periodontal Disease
Active, not recruitingObservational study
A Retrospective Comparative Evaluation of Omega-3 and Resveratrol Supplementation in Patients With Periodontitis
Periodontitis
Recruiting
Effects of Different Activation Techniques on Antimicrobial Photodynamic Therapy in Apical Periodontitis
Apical Periodontitis, Endodontic Retreatment
Recruiting
Ozone Gel Versus Chlorohexidine Gel as an Adjunct to Non-Surgical Treatment of Stage II Periodontitis Grade B Among Smokers Patients
Ozone Gel, Chlorohexidine Gel
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.
Panagiotis Theodorelos, DDS, MSc principal investigator
251 Hellenic Airforce Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Non-surgical periodontal treatment with U/S scalers and hand instruments and Periodontal treatment with U/S scalers and Vector/Paro in people with Periodontal Disease, run by 251 Hellenic Air Force & VA General Hospital 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 13 Mar 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 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: From enrollment to the end of post-treatment monitoring at 6 months). 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 13 Mar 2026.