Comparison of Two Interdental Devices for Peri-Implant Plaque Control

Not Applicable

Recruiting

• Conditions: Peri-implant Mucositis; Peri-Implantitis

• Registration Number: NCT06923748
• Lead Sponsor: University of Siena

Brief 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.

Study Timeline

• Status Verified: 2025-04
• Study Start: 2025-04-03
• Study First Submitted: 2025-04-03
• Study First Submitted QC: 2025-04-10
• Last Update Submitted: 2025-04-10
• Study First Posted: 2025-04-11
• Last Update Posted: 2025-04-11
• Primary Completion: 2025-09
• Study Completion: 2025-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 52

Inclusion Criteria

• Age between 18 and 70 years
• Presence of at least one implant loaded for ≥1 year
• Presence of bleeding (≥1 site or line/profuse bleeding) and/or suppuration on gentle probing around the implant
• Systemically healthy adults
• Able to provide written informed consent

Exclusion Criteria

• Use of anticoagulants, anti-aggregants, antibiotics, or corticosteroids in the past 3 months
• Pregnant or lactating women
• Inability to perform adequate oral hygiene

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in plaque score at implant sites	through study completion, an average of 3 months	Change in plaque score at implant sites, recorded at four/six sites per implant using a standardized plaque index system.
Change in bleeding score at implant sites	through study completion, an average of 3 months	Change in bleeding score at implant sites, recorded at four/six sites per implant using a standardized plaque index system.

Trial Locations

Locations (1)

AOUS; 🇮🇹 Siena, Italy