Peri-implant Mucositis, Peri-Implantitis
Conditions
Keywords
Peri-implant mucositis, Peri-implantitis, Interproximal devices, Prevention
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.
Interventions
DEVICESuperfloss
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.
DEVICEInterdental 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
Sponsors
University of Siena
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in plaque score at implant sites | 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. |
| Change in bleeding score at implant sites | 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. |
Countries
Italy
Outcome results
None listed