Comparison of Two Interdental Devices for Peri-Implant Plaque Control

Last updated: April 10, 2025
Sponsor: University of Siena
Overall Status: Active - Recruiting

Phase

N/A

Condition

Mucositis

Treatment

Superfloss

Interdental brush

Clinical Study ID

NCT06923748
INT001
  • Ages 18-80
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 gentleprobing around the implant

  • Systemically healthy adults

  • Able to provide written informed consent

Exclusion

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

Total Participants: 52
Treatment Group(s): 2
Primary Treatment: Superfloss
Phase:
Study Start date:
April 03, 2025
Estimated Completion Date:
September 30, 2025

Study 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.

Connect with a study center

  • AOUS

    Siena, 53100
    Italy

    Active - Recruiting

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