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

February 2, 2026 updated by: Universitat Internacional de Catalunya

Efficacy of Biofilm Removal of Different Interproximal Oral Hygiene Devices Around Posterior Single Implants in Peri-Implant Mucositis: A Randomized Clinical Trial

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

75

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Interdental Brush Group
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
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.
Experimental: Oral Irrigator Group
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
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.
Experimental: Superfloss Group
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
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.

What is the study measuring?

Primary Outcome Measures

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

Outcome Measure
Measure Description
Time Frame
Change in peri-implant probing pocket depth
Time Frame: Baseline (pre-intervention) to 1month post-intervention, 3 months post-intervetion, 6 months post-intervention
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.
Baseline (pre-intervention) to 1month post-intervention, 3 months post-intervetion, 6 months post-intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universitat Internacional de Catalunya

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

February 1, 2026

Primary Completion (Estimated)

May 1, 2027

Study Completion (Estimated)

June 1, 2027

Study Registration Dates

First Submitted

January 21, 2026

First Submitted That Met QC Criteria

February 2, 2026

First Posted (Actual)

February 6, 2026

Study Record Updates

Last Update Posted (Actual)

February 6, 2026

Last Update Submitted That Met QC Criteria

February 2, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

  • PER-ECL-2025-04

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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