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Completed

NCT Number: NCT06496594

Ultrasonic Scaler VS Erythritol for Peri-implant Maintenance of Loaded Implants With Crowns Made by Different Materials

The aim of the study is to assess the effect of a 12-month peri-implant protocol with erythritol orultrasonic scaler with peek inserts for dental implants with crowns made by different materials .

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) .

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

The mechanical debridement appointments will be carried out at the baseline, after 6 months, and after 12 months, 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 Control Record.

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Key information

Conditions

Peri-implant Mucositis

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

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)

    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)

    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)

    % 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

Ultrasonic Scaler VS Erythritol for Peri-implant Maintenance of Loaded Implants With Crowns Made by Different Materials: 12-months Randomized Clinical Trial

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Jul 11, 2024
Registry last updated
Apr 8, 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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