EdentulismNCT07474493
Comparing Cleaning Tools for Full-Arch Implant-Supported Fixed Prostheses
A study testing Superfloss, Interdental brush and Waterfloss in people with Edentulism, run by Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Edentulism
- What is being tested?
- Superfloss, Interdental brush and Waterfloss
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteChina
- Study dates
- 14 Jan 2026to 31 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Department of Oral and Maxillo-facial Implantology, Shanghai Ninth People's Hospital, School of Medicine, Shanghai Jiaotong University
Shanghai, Shanghai Municipality, 200011
Beilei Liu, 021-53315299, beilei_liu@outlook.com
About this study
Official title: 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.
- Conditions
- Edentulism
- Being tested
- Superfloss, Interdental brush, Waterfloss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SuperflossDevice
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.
Interdental brushDevice
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.
WaterflossDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Superfloss | Experimental | Using superfloss to clean the prosthesis Receives: Device: Superfloss |
| Interdental brush | Experimental | Using interdental brush to clean the prosthesis Receives: Device: Interdental brush |
| Waterfloss | Experimental | Using a water flosser to clean the prosthesis Receives: Device: Waterfloss |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plaque cleaning ratio
area of the test surface (pixels)-area of residual artificial biofilm (pixels)/area of the test surface (pixels) * 100 (%)
Measured: From enrollment to the end of every treatment at 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2026
- Study start14 Jan 2026
- Primary completion31 Jan 2027 (estimated)
- Study completion31 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EdentulismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Junyu Shi, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07474493
- Sponsor's protocol ID
- 2025.12.15.V2.0
- Status last verified
- Feb 2026
- First submitted
- 11 Mar 2026
- Last updated
- 16 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Cleaning Efficacy of Different Cleaning Aids for Full-arch Implant Supported Fixed Protheses: A Self-controlled Crossover Clinical Trial
- ClinicalTrials.gov ID
- NCT07474493
- Acronym / sponsor ID
- 2025.12.15.V2.0
- Conditions
- Edentulism
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong UniversityUniversity, hospital or other
- Study start
- 14 Jan 2026 (actual)
- Primary completion
- 31 Jan 2027 (estimated)
- Study completion
- 31 Jan 2027 (estimated)
- First posted
- 16 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Superfloss | Experimental | Device: SuperflossUsing superfloss to clean the prosthesis |
| Interdental brush | Experimental | Device: Interdental brushUsing interdental brush to clean the prosthesis |
| Waterfloss | Experimental | Device: WaterflossUsing a water flosser to clean the prosthesis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SuperflossWhen 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. | Device | Superfloss |
| Interdental brushWhen 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. | Device | Interdental brush |
| WaterflossWhen 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. | Device | Waterfloss |
Primary outcome
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 (%)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Department of Oral and Maxillo-facial Implantology, Shanghai Ninth People's Hospital, School of Medicine, Shanghai Jiaotong University
Shanghai, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Superfloss, Interdental brush and Waterfloss in people with Edentulism, run by Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Plaque cleaning ratio (time frame: From enrollment to the end of every treatment at 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2026.