This randomized clinical trial aims to evaluate and compare the efficacy of different interproximal oral hygiene devices for biofilm removal around posterior single dental implants in patients diagnosed with peri-implant mucositis.
Peri-implant mucositis is a reversible inflammatory condition of the peri-implant soft tissues caused primarily by bacterial biofilm accumulation. Effective plaque control is essential for the prevention of disease progression to peri-implantitis. However, there is limited clinical evidence regarding the comparative effectiveness of different interproximal oral hygiene devices in implant-supported sites.
A total of approximately 75 patients with posterior single implants and peri-implant mucositis will be recruited. Participants will be randomly allocated to one of the study groups, each using a specific interproximal oral hygiene device as part of their daily oral hygiene regimen. All participants will receive standardized oral hygiene instructions at baseline.
Clinical parameters related to peri-implant inflammation and plaque accumulation will be assessed at baseline and at follow-up visits at 1, 3, and 6 months. The primary outcome is the reduction of peri-implant biofilm accumulation. Secondary outcomes include changes in clinical inflammatory parameters around the implants.
The results of this study are expected to provide clinically relevant evidence to support evidence-based recommendations for interproximal oral hygiene in patients with dental implants affected by peri-implant mucositis.
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Participants assigned to this intervention group are instructed to perform daily interproximal plaque control around implant-supported crowns using the allocated interdental oral hygiene device (inter
DeviceParticipants will receive a structured oral hygiene intervention using interproximal oral hygiene devices specifically designed for use around posterior single implants diagnosed with peri-implant mucositis. The intervention consists of standardized instruction and supervised use of the assigned interproximal device according to manufacturer recommendations and a predefined clinical protocol. The device will be used by participants for daily interproximal plaque control around the implant site throughout the study period. Clinical and microbiological outcomes related to biofilm accumulation and peri-implant soft tissue inflammation will be assessed at predefined follow-up visits. No pharmacological agents are administered as part of the intervention.
Change in peri-implant biofilm accumulation
Change in interproximal peri-implant biofilm accumulation measured using a validated plaque index (e.g., Modified Plaque Index) at posterior single implants.
Change in peri-implant biofilm accumulation
The primary outcome measure is the change in peri-implant biofilm accumulation following the use of the assigned interproximal oral hygiene device. Biofilm levels will be assessed at implant-supported posterior sites using a validated plaque index specific for peri-implant tissues. Measurements will be recorded at baseline and after the intervention period, and the difference between time points will be used for analysis.
Change in peri-implant probing pocket depth
This secondary outcome assesses changes in peri-implant probing pocket depth (PPD) following the use of different interproximal oral hygiene devices. Probing depth will be measured at standardized peri-implant sites using a calibrated periodontal probe, and changes from baseline will be analyzed to evaluate the clinical response of peri-implant tissues.
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