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Active, Not Recruiting

NCT Number: NCT06288919

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Dental Implant Failed Mouth Diseases Peri-Implantitis Peri-implant Mucositis Periodontal Diseases Stomatognathic Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Pavia, Lombardy, 27100, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

Erythritol prophylactic powders

Other

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

Ultrasonic scaler with peek inserts

Other

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

Primary outcomes

  1. Change in 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.

  2. Change in 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 with a dichotomous scoring (yes/no) of bleeding sites. The sum of the bleeding sites is divided for the total sites and multiplied per 100.

  3. Change in Plaque Control Record

    Time frame: Baseline (T0), 6 months (T1), 12 months (T2), 18 months (T3) 24 months (T4)

    % assessment of the amount of plaque on dental surfaces; it is detected on 4 surfaces: distal, mesial, vestibular, lingual / palatal. The number of sites with plaque is divided by the total number of sites available in the mouth and multiplied by 100. Results indicate the index as a percentage.

Sponsors and collaborators

Lead sponsor

University of Pavia

Other

Registry information

Official study title

Erythritol vs Ultrasonic Scaler Prophylaxis Systems on Dental Implants With Different Types of Crowns: 24-months Randomized Clinical Trial

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Mar 1, 2024
Registry last updated
Jan 13, 2025

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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