Clinical Trials Logo

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT06288919
Other study ID # 2023-IMPLHYGIENE
Secondary ID
Status Enrolling by invitation
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


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)
See also
  Status Clinical Trial Phase
Completed NCT05332327 - Comparison of the Accuracy of Different Periodontal Probes for Peri-implant Pocket Registration
Enrolling by invitation NCT06063876 - Experimental Peri-implant Mucositis on Implant Sites That Were Previously Treated With or Without Implantoplasty N/A
Completed NCT04249024 - Peri-implantitis, Comparing Treatments 970 nm Laser and Mucosal Flap Surgery N/A
Withdrawn NCT03624257 - Comparing Two Treatment Modalities of Peri-implantitis - Blue Laser (445 nm) and Conventional Flap Surgery N/A
Completed NCT03157193 - Effect of Hyaluronic Acid on Perimplantitis Phase 4
Completed NCT03018795 - Ozone Therapy as an Adjunct to the Surgical Treatment of Peri-implantitis N/A
Completed NCT02375750 - Treatment of Peri-implantitis Lesions by Using Biomaterial N/A
Enrolling by invitation NCT02575274 - Peri-Implantitis Surgical Treatment an RCT Study Phase 2/Phase 3
Completed NCT04833569 - ICG-PDT, Periimplantitis, Diabetes Mellitus Phase 1
Not yet recruiting NCT04337645 - Resective Surgical Treatment of Peri-implantitis. N/A
Enrolling by invitation NCT06033859 - Incidence of Bleeding on Probing as an Indicator of Peri-Implant Disease Progression
Active, not recruiting NCT06390124 - Reconstructive Therapy of Peri-implantitis With PDGF-BB (Gem-21) Phase 4
Enrolling by invitation NCT05675241 - Characterizing the Inflammation Around Dental Implants
Recruiting NCT04983758 - 20-year Implant Survival in Periodontally Healthy and Compromised Patients
Not yet recruiting NCT04323540 - Treatment of Peri-implantitis With or Without Simultaneous Soft Tissue Augmentation N/A
Completed NCT04769609 - Reconstructive Surgical Therapy of Peri-implantitis
Completed NCT04874467 - Influence of Keratinized Mucosa on Dental Implants With Mucositis N/A
Completed NCT05724706 - An Evaluation of Salivary Oxidant and Antioxidant Levels in Peri-implant Health and Disease
Completed NCT04559841 - Regenerative Surgical Treatment of Peri-implantitis Using Nanobone With or Without Simvastatin N/A
Recruiting NCT05906810 - Impact of Non-surgical Periodontal Therapy in the Improvement of Early Endothelial Dysfunction in Subjects With Peri-implantitis and Peri-implant Mucositis N/A