Comparison of Two Interdental Devices for Peri-Implant Plaque Control

University of Siena52 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Peri-implant Mucositis Peri-Implantitis

Interventions

SuperflossDEVICE

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 brushDEVICE

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (1)

AOUS

Siena, Italy

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: through study completion, an average of 3 months

Data from ClinicalTrials.gov

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