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Ultrasonic Scaler VS Erythritol for Peri-implant Maintenance of Loaded Implants With Crowns Made by Different Materials

Ultrasonic Scaler VS Erythritol for Peri-implant Maintenance of Loaded Implants With Crowns Made by Different Materials: 12-months Randomized Clinical Trial

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06496594
Enrollment
120
Registered
2024-07-11
Start date
2023-03-30
Completion date
2025-02-15
Last updated
2025-04-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Peri-implant Mucositis

Brief summary

The aim of the study is to assess the effect of a 12-month peri-implant protocol with erythritol orultrasonic scaler with peek inserts for dental implants with crowns made by different materials . 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) . Different subgroups will be defined according to the material of the dental crown of the related implant. The mechanical debridement appointments will be carried out at the baseline, after 6 months, and after 12 months, 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 Control Record.

Interventions

erythritol with particle size of \ 14 µm will be used for 5 seconds (AIRFLOW® PLUS EMS)

ultrasonic scaler, a piezoelectric handpiece with peek inserts (Mini Piezon EMS; PI, EMS) will be used.

Sponsors

University of Pavia
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Change in Probing Depth (PD)Baseline (T0), 6 months (T1), 12 months (T2)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)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 RecordBaseline (T0), 6 months (T1), 12 months (T2)% 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.

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026