Peri-Implantitis Clinical Trial
Official title:
Erythritol vs Ultrasonic Scaler Prophylaxis Systems on Dental Implants With Different Types of Crowns: Randomized Clinical Trial
Verified date | April 2024 |
Source | University of Pavia |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
Italy | Unit of Dental Hygiene - Section of Dentistry - Department of Clinical, Surgical, Diagnostic and Paediatrics - University of Pavia | Pavia | Lombardy |
Lead Sponsor | Collaborator |
---|---|
University of Pavia |
Italy,
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) |
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