UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033316 |
|---|---|
| Receipt number | R000037978 |
| Scientific Title | Influence of using oral appliances during sleep on conditions of remaining teeth and residual ridges in removable partial denture wearers |
| Date of disclosure of the study information | 2018/07/07 |
| Last modified on | 2023/01/09 16:33:20 |
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Basic information
Public title
Influence of using oral appliances during sleep on conditions of remaining teeth and residual ridges in removable partial denture wearers
Acronym
Influence of OA on sleep bruxism in RPD wearers
Scientific Title
Influence of using oral appliances during sleep on conditions of remaining teeth and residual ridges in removable partial denture wearers
Scientific Title:Acronym
Influence of OA on sleep bruxism in RPD wearers
Region
| Japan |
Condition
Condition
partially edentulous dental arch
sleep bruxism
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the influence of using oral appliances (night dentures) during sleep on the conditionds of remaining teeth (including periodontal tissues) and residual ridges in partial removable denture wearers.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
tooth mobility
Key secondary outcomes
clinical periodontal examination
tooth attrition
residual ridge condition
quality of sleeping
radiographic examination
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
wearing oral appliances (night denture) duaring sleep at night
Interventions/Control_2
wearing no oral appliances duaring sleep at night
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
diagnosed with sleep bruxism
wearring removable partial denture
classified as B-2 to B-4 with Eichner's classification
Key exclusion criteria
Acute symptoms of oral and craniofacial diseases
Currently under periodontal treatment(except supportive periodontal therapy)
Current use of an oral appliance during sleep
Having an abutment tooth conected with next tooth with fixed prosthesis
Contraction of infectious disease or systemic disease(leukemia, HIV, etc.)
Target sample size
70
Research contact person
Name of lead principal investigator
| 1st name | Junichiro |
| Middle name | |
| Last name | Wada |
Organization
Division of Oral Health Sciences,
Track of Medical and Dental Sciences,
Graduate School of Medical and Dental Sciences,
Tokyo Medical and Dental University (TMDU)
Division name
Department of Removable Partial Prosthodontics
Zip code
113-8510
Address
1-5-45, Yushima, Bunkyo-ku, Tokyo, Japan
TEL
03-5803-5515
wadajun.rpro@tmd.ac.jp
Public contact
Name of contact person
| 1st name | Junichiro |
| Middle name | |
| Last name | Wada |
Organization
Tokyo Medical and Dental University (TMDU)
Division name
Department of Removable Partial Prosthodontics
Zip code
113-8510
Address
1-5-45, Yushima, Bunkyo-ku, Tokyo, Japan
TEL
03-5803-5515
Homepage URL
wadajun.rpro@tmd.ac.jp
Sponsor or person
Institute
Tokyo Medical and Dental University (TMDU)
Institute
Department
Personal name
Funding Source
Organization
none
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
Tokyo Medical and Dental University (TMDU)
Address
1-5-45, Yushima, Bunkyo-ku, Tokyo, #113-8510, Japan
Tel
03-5803-5515
wadajun.rpro@tmd.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
| 2018 | Year | 07 | Month | 07 | Day |
Related information
URL releasing protocol
https://center6.umin.ac.jp/cgi-bin/ctr/ctr_view_reg.cgi?recptno=R000037978
Publication of results
Published
Result
URL related to results and publications
https://www.jstage.jst.go.jp/article/jpr/advpub/0/advpub_JPR_D_21_00230/_pdf/-char/ja
Number of participants that the trial has enrolled
36
Results
At 6-month follow-up examination (T6), the mobility of the removable partial denture (RPD) abutment tooth (PTV) in intervention group was significantly lower than that in control group. PTV was significantly lower at T6 than that at baseline (T0) in intervention group. It can be concluded that a night denture placement might inhibit the increase in mobility of RPD abutment teeth and be effective in protecting them in RPD wearers with sleep bruxism.
Results date posted
| 2023 | Year | 01 | Month | 09 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Removable partial denture (RPD) wearers with a diagnosis of sleep bruxism (SB) using a miniature electromyogram device (BiteStrip).
Participant flow
The candidates for this trial were removable partial denture (RPS) wearers who visited the Tokyo Medical and Dental University (TMDU) Dental Hospital. The inclusion criteria were as follows: classified B2-B4 based on the Eichner classification, continuous use of RPD(s) for at least 1 month, and reasonable oral hygiene. The exclusion criteria were as follows: acute dental and periodontal disease, all RPD abutment teeth connected to other teeth with fixed prostheses, and current use of RPD or ND during sleep. All candidates were informed of the study purpose in written descriptions of the protocol before they provided consent to participate.
Before recruitment, candidates were screened for SB using a miniature electromyogram device (BiteStrip). BiteStrip counts the amount of masseter muscle activity above the 30% of the maximum voluntary contraction level and produces a four-grade score based on the number of counted events (L: less than 30 events; 1: 31-60 events; 2: 61-100 events; 3: more than 101 events). In this study, candidates with a BiteStrip score of 2 or 3 were diagnosed with SB and recruited as participants. After recruitment, all abutment teeth on which the direct retainers were designed were assessed using clinical periodontal examinations. In addition, participants were also assessed for SB using BiteStrip at the 6-month follow-up assessment.
Afterward, the participants were randomly allocated into two groups: the intervention group (wearing night denture (ND) during sleeping) and the control group (wearing nothing during sleeping).
Adverse events
None.
Outcome measures
Mobility of removable partial denture abutment tooth measured using electronic tooth mobility measuring device (Periotest).
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2018 | Year | 07 | Month | 05 | Day |
Date of IRB
| 2018 | Year | 09 | Month | 27 | Day |
Anticipated trial start date
| 2020 | Year | 09 | Month | 30 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 07 | Month | 07 | Day |
Last modified on
| 2023 | Year | 01 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037978
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