Periodontal DiseasesPAROXYNCT07482280
Clinical Efficacy of Vector Paro With Hydroxyapatite in the Supportive Therapy of Periodontitis
A study testing hydroxyapatite debridment and ultrasonic debridment in people with Periodontal Diseases and Hypersensitivity Dentin, run by Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia at 1 site in Italy.
Trial summary
Enamel is the most calcified tissue in the body and is composed of 92-96% by organic substances in particular hydroxyapatite. Hydroxyapatite nanoparticles are similar to the morphology and structure of tooth enamel apatite crystals and has been studied as a biomimetic material for enamel remineralization. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Periodontal Diseases, Hypersensitivity Dentin, Hydroxyapatite
- What is being tested?
- hydroxyapatite debridment and ultrasonic debridment
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteItaly
- Study dates
- 8 Feb 2023to 25 Feb 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 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Signed Informed Consent Form.
- Male and female subjects, aged 18-75 years, inclusive.
- Good general health (free of systemic diseases such as diabetes, HIV infection or genetic disorder, ongoing malignant disease of any type that could influence the outcome of the treatment and might interfere with the evaluation of the study objectives).
- History of periodontitis staging III or IV grading B or C
- At least 4 sites (split mouth 2 - 2) with probing depth ≥6 mm or pockets of 5 mm with bleeding on probing.
- Previous periodontal non-surgical treatment at least 3 months maximum 6 months.
- Availability for the 6-month duration of the study for an assigned subject.
Who cannot join
- Not willing to follow the agreed protocol.
- Presence of orthodontic appliances.
- Smokers more than 10 cigarettes per day
- Tumors or significant pathology of the soft or hard tissues of the oral cavity.
- Current radiotherapy or chemotherapy.
- Pregnant women.
- Current or past (within 3 months prior to enrollment) assumption of medications that may influence periodontal conditions and/or interfere with healing following
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Efficacy of Vector Paro With Hydroxyapatite in the Supportive Therapy of Periodontitis: a 6 Months Randomized Controlled Trial Study
Enamel is the most calcified tissue in the body and is composed of 92-96% by organic substances in particular hydroxyapatite. Hydroxyapatite nanoparticles are similar to the morphology and structure of tooth enamel apatite crystals and has been studied as a biomimetic material for enamel remineralization. Dentin hypersensitivity is a very common disorder in the adult population and it is characterized by short and intensive pain, in response to thermal or chemical stimuli. Dentin hypersensitivity can be generalized or localized, it can simultaneously affect one or more tooth surfaces and depends on the duration of the stimulus applied. In addition, there are numerous factors that can affect this condition, including gum recessions, enamel erosion, dentin exposure and periodontal disease. Many patients suffer from hypersensitivity during professional oral hygiene. The Vector system (Durr Dental, Bietigheim-Bissin gen, Germany) generates ultrasonic vibrations at a frequency of 25 kHz, which are converted by a resonant ring in a horizontal oscillation that is deflected vertically. In particular, the Vector Polish handpiece with a solution of hydroxyapatite is activated through ultrasound and it has the ability to favor the occlusion of the dentinal tubules leading to a reduction in hypersensitivity. The tip of the handpiece moves parallel along the axis of the insert, suitable for use in combination with the polishing fluid containing hydroxyapatite. The presence of this fluid associated with ultrasonic allows the root biofilm to be broken down thanks to cavitation and hydrodynamic forces; furthermore, avoiding horizontal vibrations caused a lower hypersensitivity compared to manual instruments. The aim of this randomized, controlled, split-mouth study is to investigate whether this device is effective in maintaining periodontal patients and is more gentle and comfortable during treatment, specifically in reducing sensitivity.
To test this hypothesis, the mouth of each patients, upon initial evaluation, were divided in 2 parts: before a session of nonsurgical supportive therapy in half mouth the test sites (probing depth > 5 mm or 5 mm with bleeding on probing) are treated with a traditional handpiece (control group) in the other half mouth the test sites are treated with an innovative handpiece which carries hydroxyapatite (test group).
The prevalence of residual pockets will be evaluated at 6 weeks, 3 and 6 months after the initial therapy and compared between the two groups.
Read the detailed description
TRIAL DESIGN:
A prospective, single-masked, randomized, split-mouth, longitudinal clinical trial.
POPULATION Forty-four (44) adults, aged 18-75 years, will be entered into study (randomized). It is expected that forty (40) subjects will complete the study.
Randomized subjects who deviate from the protocol (major protocol deviation) and, for this reason, are excluded from the analysis, will be replaced to guarantee that the sample required for the analysis (40) is reached.
- Being tested
- hydroxyapatite debridment, ultrasonic debridment
- Keywords
- hydroxyapatite, cavitation, ultrasonic device, hypersensitive dentin, support periodontal therapy
- Medical subject headings
- Periodontal Diseases, Dentin Sensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hydroxyapatite debridmentDevice
Test group receives debridement with Vector PARO handpiece with hydroxyapatite for 30 seconds. The presence of fluid containing hydroxyapatite associated with ultrasonic allows the root biofilm to be broken down thanks to cavitation and hydrodynamic forces.
ultrasonic debridmentDevice
Control group receives a traditional ultrasonic debridement for remove supra and sub gingival biofilm and calculus for 30 seconds
| Study group | Role | What they receive |
|---|---|---|
| Vector PARO handpiece with hydroxyapatite | Experimental | The fluid containing hydroxyapatite associated with ultrasonic treat the deep pathological pockets (PPD > 5 mm ore PPD = 5 with BOP) Receives: Device: hydroxyapatite debridment |
| Vector SCALER | Active comparator | The traditional ultrasonic debridement treat the deep pathological pockets (PPD > 5 mm ore PPD = 5 with BOP) Receives: Device: ultrasonic debridment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in PPD (periodontal depth)
Change in mean PD value for each patient measured (from the gingival margin to the bottom of the pocket). Baseline values will be compared to the values recorded in the follow-up visits.
Measured: 6 months after initial therapy.
Secondary outcomes (6)
Pocket closure
The number of experimental sites (PPD > 5mm or = 5 with BOP) becoming closed pockets (PPD ≤ 4mm).
Measured: 6 months after initial therapy
Change in REC (Clinical Gingival Recession)
Change in mean of REC value for each patient should be calculated. Baseline values will be compared to the values recorded in the follow-up visits.
Measured: 6 months after initial therapy.
Change in CAL (Clinical Attachment Level)
Change in mean of CAL value for each patient should be calculated. Baseline values will be compared to the values recorded in the follow-up visits.
Measured: 6 months after initial therapy.
Change in BOP (Bleeding on Probing)
Change in percentage of sites positive to bleeding on probing. Baseline values will be compared to the values recorded in the follow-up visits.
Measured: 6 months after initial therapy.
Change in PI (Plaque Index)
Change in percentage of site with plaque. Baseline values will be compared to the values recorded in the follow-up visits.
Measured: 6 months after initial therapy.
Change in dentin hypersensitivity
Changes on the VAS scale (1(less)-10(more)) of dentin hypersensitivity. Baseline values will be compared to the values recorded in the follow-up visits.
Measured: 6 months after initial therapy.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2026
- Study start8 Feb 2023
- Primary completion25 Feb 2026
- Study completion25 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Periodontal DiseasesStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Split Mouth, RCT
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Magda Mensi, Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
- Investigators
- Magda Mensi, Principal investigator, Asst Degli Spedali Civili Di Brescia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07482280
- Sponsor's protocol ID
- PAROXY
- Acronym
- PAROXY
- Status last verified
- Mar 2026
- First submitted
- 16 Mar 2026
- Last updated
- 23 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 23 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Efficacy of Vector Paro With Hydroxyapatite in the Supportive Therapy of Periodontitis: a 6 Months Randomized Controlled Trial Study
- ClinicalTrials.gov ID
- NCT07482280
- Acronym / sponsor ID
- PAROXY / PAROXY
- Keywords
- hydroxyapatite, cavitation, ultrasonic device, hypersensitive dentin, support periodontal therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Azienda Socio Sanitaria Territoriale degli Spedali Civili di BresciaUniversity, hospital or other
- Study start
- 8 Feb 2023 (actual)
- Primary completion
- 25 Feb 2026 (actual)
- Study completion
- 25 Feb 2026 (actual)
- First posted
- 19 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.
Enamel is the most calcified tissue in the body and is composed of 92-96% by organic substances in particular hydroxyapatite. Hydroxyapatite nanoparticles are similar to the morphology and structure of tooth enamel apatite crystals and has been studied as a biomimetic material for enamel remineralization. Dentin hypersensitivity is a very common disorder in the adult population and it is characterized by short and intensive pain, in response to thermal or chemical stimuli. Dentin hypersensitivity can be generalized or localized, it can simultaneously affect one or more tooth surfaces and depends on the duration of the stimulus applied. In addition, there are numerous factors that can affect this condition, including gum recessions, enamel erosion, dentin exposure and periodontal disease. Many patients suffer from hypersensitivity during professional oral hygiene. The Vector system (Durr Dental, Bietigheim-Bissin gen, Germany) generates ultrasonic vibrations at a frequency of 25 kHz, which are converted by a resonant ring in a horizontal oscillation that is deflected vertically. In particular, the Vector Polish handpiece with a solution of hydroxyapatite is activated through ultrasound and it has the ability to favor the occlusion of the dentinal tubules leading to a reduction in hypersensitivity. The tip of the handpiece moves parallel along the axis of the insert, suitable for use in combination with the polishing fluid containing hydroxyapatite. The presence of this fluid associated with ultrasonic allows the root biofilm to be broken down thanks to cavitation and hydrodynamic forces; furthermore, avoiding horizontal vibrations caused a lower hypersensitivity compared to manual instruments. The aim of this randomized, controlled, split-mouth study is to investigate whether this device is effective in maintaining periodontal patients and is more gentle and comfortable during treatment, specifically in reducing sensitivity.
To test this hypothesis, the mouth of each patients, upon initial evaluation, were divided in 2 parts: before a session of nonsurgical supportive therapy in half mouth the test sites (probing depth > 5 mm or 5 mm with bleeding on probing) are treated with a traditional handpiece (control group) in the other half mouth the test sites are treated with an innovative handpiece which carries hydroxyapatite (test group).
The prevalence of residual pockets will be evaluated at 6 weeks, 3 and 6 months after the initial therapy and compared between the two groups.
Detailed description
TRIAL DESIGN:
A prospective, single-masked, randomized, split-mouth, longitudinal clinical trial.
POPULATION Forty-four (44) adults, aged 18-75 years, will be entered into study (randomized). It is expected that forty (40) subjects will complete the study.
Randomized subjects who deviate from the protocol (major protocol deviation) and, for this reason, are excluded from the analysis, will be replaced to guarantee that the sample required for the analysis (40) is reached.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Split Mouth, RCT
| Arm | Type | Receives |
|---|---|---|
| Vector PARO handpiece with hydroxyapatite | Experimental | Device: hydroxyapatite debridmentThe fluid containing hydroxyapatite associated with ultrasonic treat the deep pathological pockets (PPD > 5 mm ore PPD = 5 with BOP) |
| Vector SCALER | Active comparator | Device: ultrasonic debridmentThe traditional ultrasonic debridement treat the deep pathological pockets (PPD > 5 mm ore PPD = 5 with BOP) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Signed Informed Consent Form.
- Male and female subjects, aged 18-75 years, inclusive.
- Good general health (free of systemic diseases such as diabetes, HIV infection or genetic disorder, ongoing malignant disease of any type that could influence the outcome of the treatment and might interfere with the evaluation of the study objectives).
- History of periodontitis staging III or IV grading B or C
- At least 4 sites (split mouth 2 - 2) with probing depth ≥6 mm or pockets of 5 mm with bleeding on probing.
Key exclusion criteria (7 listed)
- Not willing to follow the agreed protocol.
- Presence of orthodontic appliances.
- Smokers more than 10 cigarettes per day
- Tumors or significant pathology of the soft or hard tissues of the oral cavity.
- Current radiotherapy or chemotherapy.
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 |
|---|---|---|
| hydroxyapatite debridmentTest group receives debridement with Vector PARO handpiece with hydroxyapatite for 30 seconds. The presence of fluid containing hydroxyapatite associated with ultrasonic allows the root biofilm to be broken down thanks to cavitation and hydrodynamic forces. | Device | Vector PARO handpiece with hydroxyapatite |
| ultrasonic debridmentControl group receives a traditional ultrasonic debridement for remove supra and sub gingival biofilm and calculus for 30 seconds | Device | Vector SCALER |
Primary outcome
Change in PPD (periodontal depth)
Time frame: 6 months after initial therapy.
Change in mean PD value for each patient measured (from the gingival margin to the bottom of the pocket). Baseline values will be compared to the values recorded in the follow-up visits.
6 secondary outcomes
Pocket closure
Time frame: 6 months after initial therapy
Change in REC (Clinical Gingival Recession)
Time frame: 6 months after initial therapy.
Change in CAL (Clinical Attachment Level)
Time frame: 6 months after initial therapy.
Change in BOP (Bleeding on Probing)
Time frame: 6 months after initial therapy.
Change in PI (Plaque Index)
Time frame: 6 months after initial therapy.
Change in dentin hypersensitivity
Time frame: 6 months after initial therapy.
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 23 Mar 2026.
- 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.
Magda Mensi principal investigator
Asst Degli Spedali Civili Di Brescia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing hydroxyapatite debridment and ultrasonic debridment in people with Periodontal Diseases and Hypersensitivity Dentin, run by Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia at 1 site in Italy.
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 7 inclusion and 7 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 23 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 Italy. 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?
Change in PPD (periodontal depth) (time frame: 6 months after initial therapy.). 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 23 Mar 2026.