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

Peri-Implantitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT06288919
• Other study ID #: 2023-IMPLHYGIENE
• Status: Enrolling by invitation
• Phase: N/A
• Start date: March 1, 2024
• Est. completion date: April 10, 2026

Study information

• Verified date: April 2024
• Source: University of Pavia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 60
• Est. completion date: April 10, 2026
• Est. primary completion date: April 1, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Other:
• Erythritol prophylactic powders
erythritol with particle size of ~14 µm will be used for 5 seconds (AIRFLOW® PLUS EMS)
• Ultrasonic scaler with peek inserts
ultrasonic scaler, a piezoelectric handpiece with peek inserts (Mini Piezon EMS; PI, EMS) will be used.

Locations

Country	Name	City	State
Italy	Unit of Dental Hygiene - Section of Dentistry - Department of Clinical, Surgical, Diagnostic and Paediatrics - University of Pavia	Pavia	Lombardy

Sponsors (1)

Lead Sponsor	Collaborator
University of Pavia

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	Bleeding on Probing (BoP)	Evaluation of the presence or absence of gingival bleeding during a probing	Baseline (T0), 6 months (T1), 12 months (T2), 18 months (T3) 24 months (T4)
Primary	Plaque Index	evaluation of the amount of soft deposits on implant surfaces at each session.	Baseline (T0), 6 months (T1), 12 months (T2), 18 months (T3) 24 months (T4)