UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062475 |
|---|---|
| Receipt number | R000071499 |
| Scientific Title | Comparison of Treatment Time and Patient-Reported Outcomes Between Erythritol Powder Air-Polishing and Rubber Cup Polishing: A Randomized Crossover Clinical Trial |
| Date of disclosure of the study information | 2026/08/06 |
| Last modified on | 2026/08/05 11:46:46 |
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Basic information
Public title
Comparison of Treatment Time and Patient-Reported Outcomes Between Erythritol Powder Air-Polishing and Rubber Cup Polishing: A Randomized Crossover Clinical Trial
Acronym
EPAP-PMPR Trial
Scientific Title
Comparison of Treatment Time and Patient-Reported Outcomes Between Erythritol Powder Air-Polishing and Rubber Cup Polishing: A Randomized Crossover Clinical Trial
Scientific Title:Acronym
EPAP-PMPR Trial
Region
| Japan |
Condition
Condition
Systemically healthy adults
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare treatment time and patient-reported outcomes (PROs) between erythritol powder air-polishing (EPAP) and conventional rubber cup polishing (RC) for supragingival plaque removal in systemically healthy adults using a randomized crossover clinical trial. The primary outcome is treatment time.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Treatment time (seconds) required to complete supragingival plaque removal, measured from the first application of the assigned intervention until no disclosed supragingival plaque was visually detectable.
Key secondary outcomes
Pain during treatment (VAS), patient-reported taste, oral freshness, taste disturbance, discomfort, and treatment preference.
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment | Maneuver |
Interventions/Control_1
Erythritol powder air-polishing (EPAP). One treatment session. Supragingival plaque removal of the full dentition using the AIRFLOW Prophylaxis Master (EMS, Nyon, Switzerland) with AIRFLOW PLUS erythritol powder (mean particle size approximately 14 um). The handpiece was positioned approximately 3 to 5 mm from the tooth surface at an angle of approximately 30 to 60 degrees. Treatment was continued until no disclosed supragingival plaque was visually detectable. Each participant received the alternate intervention after a washout period of at least 2 weeks.
Interventions/Control_2
Rubber cup polishing (RC). One treatment session. Supragingival plaque removal of the full dentition was performed using a rubber prophylaxis cup attached to a low speed handpiece operating at approximately 1000 to 2000 rpm with prophylaxis paste (RDA 250). Interproximal surfaces inaccessible to the rubber cup were cleaned using a prophylaxis point. Treatment was continued until no disclosed supragingival plaque was visually detectable. Each participant received the alternate intervention after a washout period of at least 2 weeks.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 50 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
. Systemically healthy adults aged 20-50 years.
2. At least 24 natural teeth.
3. No probing pocket depth of 5 mm or greater.
4. No clinical attachment loss.
5. Able to provide written informed consent.
Key exclusion criteria
1.Systemic diseases affecting periodontal health.
2.Systemic antibiotic therapy within the previous 3 months.
3.Current smokers.
4.Pregnancy or lactation.
5.Removable prostheses.
6.Orthodontic appliances.
7.History of periodontitis.
8.Any condition considered by the investigators to interfere with study participation.
Target sample size
21
Research contact person
Name of lead principal investigator
| 1st name | Satoshi |
| Middle name | |
| Last name | Sekino |
Organization
The Nippon Dental University School of Life Dentistry at Tokyo
Division name
Department of Periodontology
Zip code
1028159
Address
1-9-20 Fujimi, Chiyoda-ku, Tokyo
TEL
03-3261-5937
sekino-s@tky.ndu.ac.jp
Public contact
Name of contact person
| 1st name | Satoshi |
| Middle name | |
| Last name | Sekino |
Organization
The Nippon Dental University School of Life Dentistry at Tokyo
Division name
Department of Periodontology
Zip code
1028159
Address
1-9-20 Fujimi, Chiyoda-ku, Tokyo
TEL
03-3261-5937
Homepage URL
sekino-s@tky.ndu.ac.jp
Sponsor or person
Institute
The Nippon Dental University
Institute
Department
Personal name
Funding Source
Organization
The Nippon Dental University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee, The Nippon Dental University School of Life Dentistry at Tokyo
Address
1-9-20,Fujimi,Chiyoda-k,Tokyo
Tel
03-3261-8311
sekino-s@tky.ndu.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 08 | Month | 06 | Day |
Related information
URL releasing protocol
N/A
Publication of results
Unpublished
Result
URL related to results and publications
N/A
Number of participants that the trial has enrolled
21
Results
Erythritol powder air polishing significantly reduced treatment time for supragingival plaque removal compared with rubber cup polishing. No significant differences were observed between the two interventions in patient reported outcomes including pain, taste, oral freshness, taste disturbance, discomfort, or treatment preference.
Results date posted
| 2026 | Year | 08 | Month | 04 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Twenty one participants were enrolled. There were 10 males and 11 females. Mean age was 33.29 plus or minus 8.47 years. Mean probing depth was 2.31 plus or minus 0.23 mm. Mean bleeding on probing was 18.31 plus or minus 11.90 percent.
Participant flow
Twenty one participants were assessed for eligibility and all were randomized. All participants received the allocated intervention and completed both treatment periods. No participants withdrew from the study and no participants were excluded from the analysis. All 21 participants were included in the final analysis.
Adverse events
No intervention related adverse events were observed during the study.
Outcome measures
Erythritol powder air polishing significantly reduced treatment time for supragingival plaque removal compared with rubber cup polishing (438 seconds versus 759 seconds, P less than 0.001). No significant differences were observed between the two interventions in pain, taste, oral freshness, taste disturbance, discomfort, or treatment preference.
Plan to share IPD
The data that support the findings of this study are available from the corresponding author upon reasonable request.
IPD sharing Plan description
Individual participant data will not be publicly available. Data supporting the findings of this study will be available from the corresponding author upon reasonable request.
Progress
Recruitment status
Completed
Date of protocol fixation
| 2021 | Year | 10 | Month | 13 | Day |
Date of IRB
| 2021 | Year | 11 | Month | 05 | Day |
Anticipated trial start date
| 2021 | Year | 11 | Month | 09 | Day |
Last follow-up date
| 2022 | Year | 01 | Month | 29 | Day |
Date of closure to data entry
| 2022 | Year | 02 | Month | 04 | Day |
Date trial data considered complete
| 2022 | Year | 02 | Month | 11 | Day |
Date analysis concluded
| 2026 | Year | 07 | Month | 24 | Day |
Other
Other related information
Management information
Registered date
| 2026 | Year | 08 | Month | 05 | Day |
Last modified on
| 2026 | Year | 08 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071499
