Comparison of Two Interdental Devices for Peri-Implant Plaque Control

November 21, 2025 updated by: Nicola Discepoli, University of Siena

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

52

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Siena, Italy, 53100
        • AOUS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Superfloss
Participants in this group will receive an electronic toothbrush combined with Superfloss as the interproximal cleaning aid. Personalized oral hygiene instructions and professional maintenance will be provided throughout the study.
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.
Experimental: Interdental Brush
Participants in this group will receive an electronic toothbrush combined with interdental brushes for interproximal cleaning. Tailored oral hygiene guidance and professional care will be offered during the follow-up visits.
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
through study completion, an average of 3 months
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.
through study completion, an average of 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Siena

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 3, 2025

Primary Completion (Actual)

November 6, 2025

Study Completion (Actual)

November 6, 2025

Study Registration Dates

First Submitted

April 3, 2025

First Submitted That Met QC Criteria

April 10, 2025

First Posted (Actual)

April 11, 2025

Study Record Updates

Last Update Posted (Actual)

November 24, 2025

Last Update Submitted That Met QC Criteria

November 21, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • INT001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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