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

NCT07482280 | Completed DMC

• 1 other identifier: PAROXY
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Hypersensitivity Dentin; Hydroxyapatite; Periodontal Diseases

Keywords

hydroxyapatite; cavitation; ultrasonic device; hypersensitive dentin; support periodontal therapy

Outcome Measures

Primary Outcomes (1)

• 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.

  6 months after initial therapy.

Secondary Outcomes (6)

• Pocket closure

  6 months after initial therapy

• Change in REC (Clinical Gingival Recession)

  6 months after initial therapy.

• Change in CAL (Clinical Attachment Level)

  6 months after initial therapy.

• Change in BOP (Bleeding on Probing)

  6 months after initial therapy.

• Change in PI (Plaque Index)

  6 months after initial therapy.

Study Arms (2)

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)

Device: hydroxyapatite debridment

Vector SCALER

ACTIVE COMPARATOR

The traditional ultrasonic debridement treat the deep pathological pockets (PPD \> 5 mm ore PPD = 5 with BOP)

Device: ultrasonic debridment

Interventions

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.

Vector PARO handpiece with hydroxyapatite

ultrasonic debridment DEVICE

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

Vector SCALER

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia: lead

Study Sites (1)

Magda Mensi

Brescia, Lombardy, 25123, Italy

Location

MeSH Terms

Conditions

Periodontal Diseases; Dentin Sensitivity

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases; Tooth Diseases

Study Officials

• Magda Mensi

  ASST Spedali Civili di Brescia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: researcher

Model Details: Split Mouth, RCT

Study Record Dates

• First Submitted: March 16, 2026
• First Posted: March 19, 2026
• Study Start: February 8, 2023
• Primary Completion: February 25, 2026
• Study Completion: February 25, 2026
• Last Updated: March 23, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)