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

April 25, 2024 updated by: Andrea Scribante, University of Pavia

Erythritol vs Ultrasonic Scaler Prophylaxis Systems on Dental Implants With Different Types of Crowns: Randomized Clinical Trial

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.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

60

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 Contact

Study Locations

  • Italy
    • Lombardy
      • Pavia, Lombardy, Italy, 27100
        • Unit of Dental Hygiene - Section of Dentistry - Department of Clinical, Surgical, Diagnostic and Paediatrics - University of Pavia

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:

  • 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

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Erythritol group
Other: Erythritol prophylactic powders
erythritol with particle size of ~14 µm will be used for 5 seconds (AIRFLOW® PLUS EMS)
Active Comparator: Ultrasonic scaler
Other: Ultrasonic scaler with peek inserts
ultrasonic scaler, a piezoelectric handpiece with peek inserts (Mini Piezon EMS; PI, EMS) will be used.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Probing Depth (PD)
Time Frame: Baseline (T0), 6 months (T1), 12 months (T2), 18 months (T3) 24 months (T4)
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.
Baseline (T0), 6 months (T1), 12 months (T2), 18 months (T3) 24 months (T4)
Bleeding on Probing (BoP)
Time Frame: Baseline (T0), 6 months (T1), 12 months (T2), 18 months (T3) 24 months (T4)
Evaluation of the presence or absence of gingival bleeding during a probing
Baseline (T0), 6 months (T1), 12 months (T2), 18 months (T3) 24 months (T4)
Plaque Index
Time Frame: Baseline (T0), 6 months (T1), 12 months (T2), 18 months (T3) 24 months (T4)
evaluation of the amount of soft deposits on implant surfaces at each session.
Baseline (T0), 6 months (T1), 12 months (T2), 18 months (T3) 24 months (T4)

Collaborators and Investigators

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

Sponsor

University of Pavia

Investigators

  • Principal Investigator: Andrea Scribante, DDS, PhD, MS, University of Pavia

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)

March 1, 2024

Primary Completion (Estimated)

April 1, 2026

Study Completion (Estimated)

April 10, 2026

Study Registration Dates

First Submitted

February 23, 2024

First Submitted That Met QC Criteria

February 29, 2024

First Posted (Actual)

March 1, 2024

Study Record Updates

Last Update Posted (Estimated)

April 26, 2024

Last Update Submitted That Met QC Criteria

April 25, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2023-IMPLHYGIENE

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Data will be available upon motivated request to Principal Investigator.

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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