Clinical Efficacy of Vector Paro With Hydroxyapatite in the Supportive Therapy of Periodontitis (PAROXY)

March 19, 2026 updated by: Magda Mensi, Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • Lombardy
      • Brescia, Lombardy, Italy, 25123
        • Magda Mensi

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Vector PARO handpiece with hydroxyapatite
The fluid containing hydroxyapatite associated with ultrasonic treat the deep pathological pockets (PPD > 5 mm ore PPD = 5 with BOP)
Device: hydroxyapatite debridment
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.
Active Comparator: Vector SCALER
The traditional ultrasonic debridement treat the deep pathological pockets (PPD > 5 mm ore PPD = 5 with BOP)
Device: ultrasonic debridment
Control group receives a traditional ultrasonic debridement for remove supra and sub gingival biofilm and calculus for 30 seconds

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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 months after initial therapy.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pocket closure
Time Frame: 6 months after initial therapy
The number of experimental sites (PPD > 5mm or = 5 with BOP) becoming closed pockets (PPD ≤ 4mm).
6 months after initial therapy
Change in REC (Clinical Gingival Recession)
Time Frame: 6 months after initial therapy.
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.
6 months after initial therapy.
Change in CAL (Clinical Attachment Level)
Time Frame: 6 months after initial therapy.
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.
6 months after initial therapy.
Change in BOP (Bleeding on Probing)
Time Frame: 6 months after initial therapy.
Change in percentage of sites positive to bleeding on probing. Baseline values will be compared to the values recorded in the follow-up visits.
6 months after initial therapy.
Change in PI (Plaque Index)
Time Frame: 6 months after initial therapy.
Change in percentage of site with plaque. Baseline values will be compared to the values recorded in the follow-up visits.
6 months after initial therapy.
Change in dentin hypersensitivity
Time Frame: 6 months after initial therapy.
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.
6 months after initial therapy.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia

Investigators

  • Principal Investigator: Magda Mensi, ASST Spedali Civili di Brescia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 8, 2023

Primary Completion (Actual)

February 25, 2026

Study Completion (Actual)

February 25, 2026

Study Registration Dates

First Submitted

March 16, 2026

First Submitted That Met QC Criteria

March 16, 2026

First Posted (Actual)

March 19, 2026

Study Record Updates

Last Update Posted (Actual)

March 23, 2026

Last Update Submitted That Met QC Criteria

March 19, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PAROXY

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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