UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056470 |
|---|---|
| Receipt number | R000061704 |
| Scientific Title | Adhesive inhibition of fluoride prophy paste while bracket bonding |
| Date of disclosure of the study information | 2024/12/17 |
| Last modified on | 2025/01/07 10:46:28 |
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Basic information
Public title
Influence of fluoride prophy paste to bracket bonding
Acronym
Influence of fluoride prophy paste
Scientific Title
Adhesive inhibition of fluoride prophy paste while bracket bonding
Scientific Title:Acronym
Adhesive inhibition of fluoride prophy paste
Region
| Japan |
Condition
Condition
malocclusion
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
When attaching brackets used for orthodontic treatment, brush polishing is performed with a tooth surface polishing material before the tooth surface preparation and bracket bonding. At that time, the tooth surface polishing material that does not contain fluorine is used because of taking into account the effects of tooth surface treatment and adhesion.
However, it is questionable whether the tooth surface adhesion is affected by short-time polishing using the polishing material containing fluoride toothpaste. Therefore, the purpose of this study is to conduct a randomized controlled trial and investigate the short-term polishing effects of fluoride-containing tooth surface polishing material.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Bond failure
Key secondary outcomes
Extension of treatment period
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Use of fluoride-contain polishing materials
Interventions/Control_2
Use of fluoride-free polishing materials
Interventions/Control_3
Assign and use fluorine-containing and non-fluorine-containing polishing materials to the crossover
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
| 12 | years-old | <= |
Age-upper limit
| 60 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
human teeth
Key exclusion criteria
Patients with cavity, treeted teeth
No interference from the bonded brackets
Patients with craniofacial abnormalities (e.g., cleft lip and palate)
No consent to participate in this study
Target sample size
72
Research contact person
Name of lead principal investigator
| 1st name | Yasuhiro |
| Middle name | |
| Last name | Namura |
Organization
Nihon university school of dentistry
Division name
Department of orthodontics
Zip code
101-8310
Address
1-8-13 Kandasurugadai,Chiyoda-ku,Tokyo
TEL
03-3219-8080
deke20253@g.nihon-u.ac.jp
Public contact
Name of contact person
| 1st name | Yasuhiro |
| Middle name | |
| Last name | Namura |
Organization
Nihon university school of dentistry
Division name
department of orhodontics
Zip code
101-8310
Address
1-8-13 Kandasurudadai,Chiyoda-ku,Tokyo
TEL
03-3219-8080
Homepage URL
deke20253@g.nihon-u.ac.jp
Sponsor or person
Institute
Department of orthodontics, Nihon university school of dentistry
Institute
Department
Personal name
Yasuhiro Namura
Funding Source
Organization
Sato Fund, Nihon University School of Dentistry
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nihon university school of dentistry
Address
1-8-13 Kandasurudadai,Chiyoda-ku,Tokyo
Tel
03-3219-8080
deke20253@g.nihon-u.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
| 2024 | Year | 12 | Month | 17 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
72
Results
In this study, 1345 brackets were subjected, and the total failure rate was 2.5 %. Bond failure rates in Groups 1 and 2 were 1.5% and 4.1% respectively and Group 1 was less than Group 2. In the sprit-mouth test, those in Groups 3 and 4 were 2.5% and 1.0%.
Results date posted
| 2024 | Year | 12 | Month | 16 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
The average age of participants was 24.6 years. Twenty-eight participants were more than 20 years. The proportions of participants were 68% Female and 32 % Male.
Participant flow
Eighty patients were assessed for eligibility: 72 patients met inclusion criteria, gave informed consent and were allocated. Group 1 included 25 participants who received polishing with fluoride toothpaste before bonding brackets. Group 2 included 24 participants who received polishing with non-fluoride toothpaste before bonding brackets. Due to the split-mouth design, the remaining 23 were allocated the area polishing with fluoride toothpaste (Group 3) and the area polishing with non-fluoride toothpaste (Group 4).
The recruitment of the participants for the trial began in December 2022 and ended in December 2023. The trial was completed in June 2024. The 72 patients who completed the trial were included in the analyses.
Adverse events
Outcome measures
The patients were examined approximately every 3 to 4 weeks, and the presence or absence of bond failure was checked and evaluated, and bond failure was recorded even if 3 to 4 weeks did not pass when patients visited the clinic to complain of bond failure. In the teeth occurring bond failure, the surface is polished non-fluoride toothpaste and brackets were rebonded by resin composite the following phosphoric acid etching and priming.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2022 | Year | 10 | Month | 27 | Day |
Date of IRB
| 2022 | Year | 11 | Month | 17 | Day |
Anticipated trial start date
| 2022 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 06 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 12 | Month | 17 | Day |
Last modified on
| 2025 | Year | 01 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000061704
