- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07474493
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
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
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:
- Beilei Liu
- Phone Number: 021-53315299
- Email: beilei_liu@outlook.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
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
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
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)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
Clinical Trials on Edentulism
-
Nobel BiocareCompletedPartial Edentulism | Complete Edentulism
-
Al-Azhar UniversityRecruitingEdentulism | Edentulism in Lower JawEgypt
-
Nobel BiocareCompletedPartial Edentulism | Complete Edentulism
-
Dentsply Sirona Implants and ConsumablesCompletedPartial Edentulism | Edentulism NosSweden
-
Universidad Complutense de MadridRecruiting
-
Dentsply Sirona ImplantsCompletedEdentulismGermany, United States, Italy
-
Elite OdontoiatricaActive, not recruiting
-
University of Alabama at BirminghamACE Surgical Supply, Inc.Completed
-
Roberto VillaNobel Biocare Services AGNot yet recruiting
-
Mansoura UniversityCompleted
Clinical Trials on Superfloss
-
University of SienaCompletedPeri-Implantitis | Peri-implant MucositisItaly
-
Riyadh Colleges of Dentistry and PharmacyUnknown
-
Universitat Internacional de CatalunyaCompleted