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Completed

NCT Number: NCT07482280

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

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Magda Mensi

Brescia, Lombardy, 25123, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

hydroxyapatite debridment

Device

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 debridment

Device

Control group receives a traditional ultrasonic debridement for remove supra and sub gingival biofilm and calculus for 30 seconds

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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).

  2. 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.

  3. 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.

  4. 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.

  5. 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. 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.

Sponsors and collaborators

Lead sponsor

Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia

Other

Registry information

Official study title

Clinical Efficacy of Vector Paro With Hydroxyapatite in the Supportive Therapy of Periodontitis: a 6 Months Randomized Controlled Trial Study

Acronym: PAROXY

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Mar 19, 2026
Registry last updated
Mar 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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