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

NCT07474493 | Recruiting DMC

• 1 other identifier: 2025.12.15.V2.0
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Edentulism

Outcome Measures

Primary Outcomes (1)

• Plaque cleaning ratio

  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

Study Arms (3)

Superfloss

EXPERIMENTAL

Using superfloss to clean the prosthesis

Device: Superfloss

Interdental brush

EXPERIMENTAL

Using interdental brush to clean the prosthesis

Device: Interdental brush

Waterfloss

EXPERIMENTAL

Using a water flosser to clean the prosthesis

Device: Waterfloss

Interventions

Superfloss DEVICE

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.

Superfloss

Interdental brush DEVICE

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.

Interdental brush

Waterfloss DEVICE

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.

Waterfloss

Eligibility Criteria

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

You may qualify if:

• Age ≥18 years;
• 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;
• Patients with good compliance who provide informed consent.

You may not qualify if:

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

Sponsors & Collaborators

• Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University: lead

Study Sites (1)

Department of Oral and Maxillo-facial Implantology, Shanghai Ninth People's Hospital, School of Medicine, Shanghai Jiaotong University

Shanghai, Shanghai Municipality, 200011, China

RECRUITING

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 11, 2026
• First Posted: March 16, 2026
• Study Start: January 14, 2026
• Primary Completion (Estimated): January 31, 2027
• Study Completion (Estimated): January 31, 2027
• Last Updated: March 16, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)