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

Not Applicable

Completed

• Conditions: Peri-implant Mucositis
• Interventions: Other: Erythritol prophylactic powders; Other: Ultrasonic scaler with peek inserts

• Registration Number: NCT06496594
• Lead Sponsor: University of Pavia

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-03-30
• Study First Submitted: 2024-07-03
• Study First Submitted QC: 2024-07-10
• Study First Posted: 2024-07-11
• Primary Completion: 2025-02-10
• Study Completion: 2025-02-15
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-05
• Last Update Posted: 2025-04-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Erythritol group	Erythritol prophylactic powders	-
Ultrasonic scaler	Ultrasonic scaler with peek inserts	-

Primary Outcome Measures

Name	Time	Method
Change in Probing Depth (PD)	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.
Change in Bleeding on Probing (BoP)	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.
Change in Plaque Control Record	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.

Trial Locations

Locations (1)

Unit of Dental Hygiene - Section of Dentistry - Department of Clinical, Surgical, Diagnostic and Paediatrics - University of Pavia; 🇮🇹 Pavia, Lombardy, Italy