Comparison of Two Interdental Devices for Peri-Implant Plaque Control

University of Siena

Status: Completed

Conditions: Peri-implant Mucositis; Peri-Implantitis

Treatments: Device: Interdental brush; Device: Superfloss

Study type: Interventional

Funder types: Other

Identifiers

NCT06923748

INT001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 52 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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52 participants in 2 patient groups

Superfloss

Experimental group

Description:

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.

Treatment:

Device: Superfloss

Interdental Brush

Experimental group

Description:

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.

Treatment:

Device: Interdental brush