Comparing Cleaning Tools for Full-Arch Implant-Supported Fixed Prostheses

Comparison of Cleaning Efficacy of Different Cleaning Aids for Full-arch Implant Supported Fixed Protheses: A Self-controlled Crossover Clinical Trial

For patients with complete edentulism, full-arch implant-supported fixed prostheses can effectively restore functions such as mastication, esthetics, and speech. Their long-term clinical outcomes are predictable, and patient satisfaction is generally high. However, the probability of biological complications associated with full-arch implant-supported fixed prostheses within 10 years can be as high as 91.2%. Poor oral hygiene and plaque accumulation are important risk factors for these biological complications.

Proper cleaning and maintenance are crucial for the long-term success of full-arch implant-supported fixed prostheses. However, the most effective cleaning method remains unclear. Superfloss, interdental brushes, and water floss are commonly used auxiliary cleaning tools, but in vivo studies evaluating their cleaning efficacy are limited. Therefore, a randomized controlled study with a relatively long observation period is needed to better evaluate the cleaning effectiveness of different methods-superfloss, interdental brushes, and water floss-in patients with full-arch implant-supported fixed prostheses.

This study adopts a self-controlled, three-phase crossover design. Participants will sequentially use superfloss (S), interdental brushes (I), and a water flosser (W) to clean the surface of full-arch implant-supported fixed prostheses. Each cleaning method will be used for three months, after which a follow-up examination will be conducted. The participants will then switch to the second cleaning method, followed by another evaluation after three months. Finally, they will switch to the third cleaning method, and a final examination will be performed after an additional three months, completing the study.

Study Overview

Status

Recruiting

Conditions

Study Type

Interventional

Enrollment (Estimated)

18

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China, 200011
        • Recruiting
        • Department of Oral and Maxillo-facial Implantology, Shanghai Ninth People's Hospital, School of Medicine, Shanghai Jiaotong University
        • Contact:

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Age ≥18 years;
  2. Patients with single-arch or full-arch edentulism / terminal dentition who have completed implant placement and immediate restoration and are scheduled to receive the definitive prosthesis;
  3. Patients with good compliance who provide informed consent.

Exclusion Criteria:

  1. Smoking (≥10 cigarettes per day);
  2. Lack of self-care ability and unable to perform prosthesis cleaning independently;
  3. Uncontrolled periodontitis in remaining teeth or unstable periodontal condition;
  4. Presence of failed implants in the full-arch implant restoration and requiring second implantation.

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: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Superfloss
Using superfloss to clean the prosthesis
When using superfloss to clean the prosthesis, after routine tooth brushing, the stiffened threading end should be inserted from beneath the bridge or through the space between implant abutments so that the spongy segment is positioned under the bridge or around the abutments. The tissue surface of the prosthesis and the surrounding abutment areas are then gently cleaned using a back-and-forth pulling motion. The entire procedure should be performed gently, avoiding excessive force to prevent soft tissue injury.
Experimental: Interdental brush
Using interdental brush to clean the prosthesis
When using an interdental brush to clean the prosthesis, a brush head with an appropriate diameter should be selected so that it can pass easily through the space between the bridge and the abutment without causing friction or damage. The brush head should be gently inserted into the inter-implant space and moved back and forth in a horizontal or slightly angled direction. Each site should be brushed 2-3 times, avoiding forceful insertion or bending of the bristles. Cleaning can be performed sequentially from one side of the full-arch prosthesis to the other, ensuring that the area around each abutment is thoroughly cleaned. The brush head should be replaced regularly to maintain bristle elasticity and cleaning effectiveness.
Experimental: Waterfloss
Using a water flosser to clean the prosthesis
When using a water flosser to clean the prosthesis, the water pressure should be adjusted to the maximum level that the patient can comfortably tolerate. Starting from one end of the prosthesis, the nozzle should be moved slowly along the edge and underside of the bridge, allowing the water stream to flush out debris and plaque around the abutments and beneath the bridge.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Plaque cleaning ratio
Time Frame: From enrollment to the end of every treatment at 12 weeks
area of the test surface (pixels)-area of residual artificial biofilm (pixels)/area of the test surface (pixels) * 100 (%)
From enrollment to the end of every treatment at 12 weeks

Collaborators and Investigators

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

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 (Actual)

January 14, 2026

Primary Completion (Estimated)

January 31, 2027

Study Completion (Estimated)

January 31, 2027

Study Registration Dates

First Submitted

March 11, 2026

First Submitted That Met QC Criteria

March 11, 2026

First Posted (Actual)

March 16, 2026

Study Record Updates

Last Update Posted (Actual)

March 16, 2026

Last Update Submitted That Met QC Criteria

March 11, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

  • 2025.12.15.V2.0

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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