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NCT Number: NCT06923748

Comparison of Two Interdental Devices for Peri-Implant Plaque Control

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.

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Key information

Conditions

Peri-implant Mucositis Mouth Diseases Peri-Implantitis Periodontal Diseases Stomatognathic Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

AOUS

Siena, 53100, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Superfloss

Device

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.

Interdental Brush

Device

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

Primary outcomes

  1. Change in plaque score at implant sites

    Time frame: 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.

  2. Change in bleeding score at implant sites

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Siena

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Apr 11, 2025
Registry last updated
Nov 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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