Effectiveness of Interproximal Cleaning Devices for Biofilm Removal Around Posterior Single Implants With Peri-Implant Mucositis

Sponsor
Universitat Internacional de Catalunya
Study ID
NCT07393828
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
N/A - N/A
Healthy Volunteers
Not accepted

Interventions

  • 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 — DEVICE
    Participants 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.

Study Details

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.

Key Dates

Start date
Feb 28, 2026
Status verified
Feb 2026
Primary completion
May 31, 2027
Completion
Jun 30, 2027

Study Design

Enrollment
75 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Interdental Brush Group
    Participants use interdental brushes for interproximal plaque control around posterior implants.
  • Experimental: Oral Irrigator Group
    Participants use an oral irrigator for interproximal plaque control around posterior implants.
  • Experimental: Superfloss Group
    Participants use Superfloss for interproximal plaque control around posterior implants.

Primary Outcome Measure

Change in peri-implant biofilm accumulation [ Time Frame: Baseline (pre-intervention) to 1month post-intervention, 3 months post-intervetion, 6 months post-intervention ]

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