Erythritol vs Ultrasonic Scaler Prophylaxis Systems on Dental Implants With Crowns Made by Different Materials

NCT ID: NCT06288919

Last Updated: 2025-01-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-03-01

Study Completion Date

2026-04-10

Brief Summary

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The aim of the study is to assess which prophylaxis methods is the most suitable for peri-implant hygiene between erythritol and ultrasonic scaler with peek inserts.

A randomized clinical trial will be conducted on the patient. Patients will be randomly divided into two groups:

* Erythritol group: erythritol with a particle size of \~14 µm will be used for 5 seconds (AIRFLOW® PLUS EMS)
* Ultrasonic scaler group: a piezoelectric handpiece with peek inserts (Mini Piezon EMS; PI EMS) will be used.

Different subgroups will be defined according to the material of the dental crown of the related implant.

The oral hygiene session will be carried out every 6 months (2-years follow-up; 6 sessions), after instruction and motivation of the patient, completion of the clinical chart with the recording of the Probing Depth (evaluation in mm of the peri-implant sulcus taken by a periodontal probe; 4 surfaces of the gingival margin are detected: vestibular, palatal/lingual, mesial, distal), Bleeding on Probing and Plaque Index.

Detailed Description

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The aim of the study is to assess which prophylaxis methods is the most suitable for peri-implant hygiene between erythritol and ultrasonic scaler with peek inserts.

A randomized clinical trial will be conducted on the patient. Patients will be randomly divided into two groups:

* Erythritol group: erythritol with a particle size of \~14 µm will be used for 5 seconds (AIRFLOW® PLUS EMS)
* Ultrasonic scaler group: a piezoelectric handpiece with peek inserts (Mini Piezon EMS; PI EMS) will be used.

Different subgroups will be defined according to the material of the dental crown of the related implant: feldspathic ceramic, zirconia and lithium disilicate.

The oral hygiene session will be carried out every 6 months (2-years follow-up; 6 sessions), after instruction and motivation of the patient, completion of the clinical chart with the recording of the Probing Depth (evaluation in mm of the peri-implant sulcus taken by a periodontal probe; 4 surfaces of the gingival margin are detected: vestibular, palatal/lingual, mesial, distal), Bleeding on Probing and Plaque Index.

Conditions

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Dental Implant Failed Peri-implant Mucositis Peri-Implantitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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Erythritol group

Group Type EXPERIMENTAL

Erythritol prophylactic powders

Intervention Type OTHER

erythritol with particle size of \~14 µm will be used for 5 seconds (AIRFLOW® PLUS EMS)

Ultrasonic scaler

Group Type ACTIVE_COMPARATOR

Ultrasonic scaler with peek inserts

Intervention Type OTHER

ultrasonic scaler, a piezoelectric handpiece with peek inserts (Mini Piezon EMS; PI, EMS) will be used.

Interventions

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Erythritol prophylactic powders

erythritol with particle size of \~14 µm will be used for 5 seconds (AIRFLOW® PLUS EMS)

Intervention Type OTHER

Ultrasonic scaler with peek inserts

ultrasonic scaler, a piezoelectric handpiece with peek inserts (Mini Piezon EMS; PI, EMS) will be used.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Age between 18 and 70
* Presence of at least one dental implant
* Good compliance

Exclusion Criteria

* Patients with cardiac stimulators
* Patients with neurological disorders
* Patients with psychological disorders
* Pregnant women
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Pavia

OTHER

Sponsor Role lead

Responsible Party

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Andrea Scribante

Associate Professor, Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Andrea Scribante, DDS, PhD, MS

Role: PRINCIPAL_INVESTIGATOR

University of Pavia

Locations

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Unit of Dental Hygiene - Section of Dentistry - Department of Clinical, Surgical, Diagnostic and Paediatrics - University of Pavia

Pavia, Lombardy, Italy

Site Status

Countries

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Italy

Other Identifiers

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2023-IMPLHYGIENE

Identifier Type: -

Identifier Source: org_study_id

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