Erythritol vs Ultrasonic Scaler Prophylaxis Systems on Dental Implants With Crowns Made by Different Materials
- Conditions
- Peri-ImplantitisDental Implant FailedPeri-implant Mucositis
- Interventions
- Other: Erythritol prophylactic powdersOther: Ultrasonic scaler with peek inserts
- Registration Number
- NCT06288919
- Lead Sponsor
- University of Pavia
- 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.
- Detailed 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 & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 120
- Age between 18 and 70
- Presence of at least one dental implant
- Good compliance
- 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), 18 months (T3) 24 months (T4) 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), 18 months (T3) 24 months (T4) 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), 18 months (T3) 24 months (T4) % 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Unit of Dental Hygiene - Section of Dentistry - Department of Clinical, Surgical, Diagnostic and Paediatrics - University of Pavia
🇮🇹Pavia, Lombardy, Italy