NCT06923748

Comparison of Two Interdental Devices for Peri-Implant Plaque Control

Comparison of Two Different Interproximal Cleaning Devices Around Dental Implants: A Randomized Clinical Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 52 (actual)
• Sponsor: University of Siena · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This randomized clinical trial aims to compare the efficacy of two interproximal cleaning devices-superfloss and interdental brushes- in patients diagnosed with peri-implant diseases. The study evaluates plaque control and bleeding scores. Patients will be randomly assigned to one of two oral hygiene protocols and will be monitored through clinical examinations and validated questionnaires assessing both clinical and radiographic parameters and patient-reported outcomes.

Detailed description

This single-center, randomized, parallel-arm clinical trial aims to compare the efficacy of superfloss and interdental brushes, used in combination with an electronic toothbrush, in patients with peri-implant diseases. Participants will be randomly assigned to one of two oral hygiene protocols. Clinical assessments will be performed at baseline, 6 weeks, and 3 months, including plaque index, bleeding scores, and probing depth. Radiographic measurements and standardized patient-reported questionnaires (food impaction and oral hygiene self-efficacy) will also be used. The primary outcome is the reduction of plaque and gingival inflammatory scores at implant sites.

Conditions

• Peri-implant Mucositis
• Peri-Implantitis

Interventions

Type	Name	Description
DEVICE	Superfloss	Use of Superfloss daily as the interproximal cleaning device, combined with an electronic toothbrush, as part of a tailored oral hygiene protocol in patients with peri-implant disease.
DEVICE	Interdental brush	Use of interdental brush once daily as the interproximal cleaning device, combined with an electronic toothbrush, within a professional oral hygiene maintenance program for peri-implant disease

Timeline

• Start date: 2025-04-03
• Primary completion: 2025-11-06
• Completion: 2025-11-06
• First posted: 2025-04-11
• Last updated: 2025-11-24

Locations

1 site across 1 country: Italy