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

NCT07393828 | Not Yet Recruiting

• 1 other identifier: PER-ECL-2025-04
• Study Type: interventional
• Target: 75
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Peri-implant Mucositis

Outcome Measures

Primary Outcomes (2)

• 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.

  Baseline (pre-intervention) to 1month post-intervention, 3 months post-intervetion, 6 months post-intervention

• 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.

  Baseline (pre-intervention) to 1month post-intervention, 3 months post-intervetion, 6 months post-intervention

Secondary Outcomes (1)

• Change in peri-implant probing pocket depth

  Baseline (pre-intervention) to 1month post-intervention, 3 months post-intervetion, 6 months post-intervention

Study Arms (3)

Interdental Brush Group

EXPERIMENTAL

Participants use interdental brushes for interproximal plaque control around posterior implants.

Device: 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

Oral Irrigator Group

EXPERIMENTAL

Participants use an oral irrigator for interproximal plaque control around posterior implants.

Device: 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

Superfloss Group

EXPERIMENTAL

Participants use Superfloss for interproximal plaque control around posterior implants.

Device: 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

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.

Interdental Brush Group; Oral Irrigator Group; Superfloss Group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults aged ≥18 years. Presence of at least one posterior single dental implant in function for ≥12 months.
• Diagnosis of peri-implant mucositis, defined as bleeding on probing with probing depths ≤5 mm and no radiographic bone loss beyond initial remodeling.
• Good general health (ASA I-II). Ability and willingness to comply with study procedures and follow-up visits. Provision of written informed consent.

You may not qualify if:

• Diagnosis of peri-implantitis (radiographic bone loss beyond initial remodeling).
• Uncontrolled systemic diseases affecting periodontal or peri-implant health (e.g., uncontrolled diabetes mellitus).
• Use of systemic antibiotics or anti-inflammatory drugs within the previous 3 months.
• Current pregnancy or lactation. Current smoker of \>10 cigarettes/day. History of periodontal therapy or professional implant maintenance within the previous 3 months.
• Use of medications known to affect bone metabolism (e.g., bisphosphonates). Inability to perform adequate oral hygiene or to attend scheduled study visits.

Sponsors & Collaborators

• Universitat Internacional de Catalunya: lead

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 21, 2026
• First Posted: February 6, 2026
• Study Start: February 1, 2026
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: February 6, 2026

Record last verified: 2026-02