Comparison of Two Interdental Devices for Peri-Implant Plaque Control

NCT ID: NCT06923748

Last Updated: 2025-11-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 52 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-04-03
• Study Completion Date: 2025-11-06

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.

Conditions

Peri-implant Mucositis; Peri-Implantitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

Superfloss

Intervention Type: 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

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.

Group Type: EXPERIMENTAL

Interdental brush

Intervention Type: 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

Interventions

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.

Intervention Type: 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

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Siena

OTHER

Sponsor Role: lead

Responsible Party

Nicola Discepoli

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

AOUS

Siena, , Italy

Countries

Italy

Other Identifiers

INT001

Identifier Type: -

Identifier Source: org_study_id