Comparison of Two Interdental Devices for Peri-Implant Plaque Control

NCT06923748 | Completed

• 1 other identifier: INT001
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

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.

Conditions

Peri-implant Mucositis; Peri-Implantitis

Keywords

Peri-implant mucositis; Peri-implantitis; Interproximal devices; Prevention

Outcome Measures

Primary Outcomes (2)

• Change in plaque score at implant sites

  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

  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

Study Arms (2)

Superfloss

EXPERIMENTAL

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

Interdental Brush

EXPERIMENTAL

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

Interventions

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.

Superfloss

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

Interdental Brush

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Siena: lead

Study Sites (1)

AOUS

Siena, 53100, Italy

Location

MeSH Terms

Conditions

Peri-Implantitis

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: April 3, 2025
• First Posted: April 11, 2025
• Study Start: April 3, 2025
• Primary Completion: November 6, 2025
• Study Completion: November 6, 2025
• Last Updated: November 24, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)