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

NCT06496594 | Completed

• 1 other identifier: 2024-CROWNSHYGIENE
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Peri-implant Mucositis

Outcome Measures

Primary Outcomes (3)

• Change in Probing Depth (PD)

  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)

• Change in Bleeding on Probing (BoP)

  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.

  Baseline (T0), 6 months (T1), 12 months (T2)

• Change in Plaque Control Record

  % 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.

  Baseline (T0), 6 months (T1), 12 months (T2)

Study Arms (2)

Erythritol group

EXPERIMENTAL

Other: Erythritol prophylactic powders

Ultrasonic scaler

ACTIVE COMPARATOR

Other: Ultrasonic scaler with peek inserts

Interventions

Erythritol prophylactic powders OTHER

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

Erythritol group

Ultrasonic scaler with peek inserts OTHER

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

Ultrasonic scaler

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Patients with cardiac stimulators
• Patients with neurological disorders
• Patients with psychological disorders
• Pregnant women

Sponsors & Collaborators

• University of Pavia: lead

Study Sites (1)

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

Pavia, Lombardy, 27100, Italy

Location

Study Officials

• Andrea Scribante

  University of Pavia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Principal Investigator

Study Record Dates

• First Submitted: July 3, 2024
• First Posted: July 11, 2024
• Study Start: March 30, 2023
• Primary Completion: February 10, 2025
• Study Completion: February 15, 2025
• Last Updated: April 8, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)