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

NCT06288919 | Active Not Recruiting

• 1 other identifier: 2023-IMPLHYGIENE
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Dental Implant Failed; Peri-implant Mucositis; Peri-Implantitis

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), 18 months (T3) 24 months (T4)

• 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), 18 months (T3) 24 months (T4)

• 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), 18 months (T3) 24 months (T4)

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

MeSH Terms

Conditions

Peri-Implantitis

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Study Officials

• Andrea Scribante, DDS, PhD, MS

  University of Pavia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: 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: February 23, 2024
• First Posted: March 1, 2024
• Study Start: March 1, 2024
• Primary Completion: April 1, 2026
• Study Completion: April 10, 2026
• Last Updated: January 13, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)