UMIN-ICDS Clinical Trial

Public title

Evaluation of the retentive force of the palatal plate under the use of denture adhesives developed for dry mouth

Acronym

Evaluation of the retentive force of the palatal plate under the use of denture adhesives developed for dry mouth

Scientific Title

Evaluation of the retentive force of the palatal plate under the use of denture adhesives developed for dry mouth

Scientific Title:Acronym

Evaluation of the retentive force of the palatal plate under the use of denture adhesives developed for dry mouth

Region

Japan

Condition

dental disease

Classification by specialty

Dental medicine

Adult

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

15 dentists (healthy adults) belonging to the Department of Geriatric Dentistry, Showa University School of Dentistry. A palatal plate was made for the participants, denture adhesives and oral moisturizers were applied and worn in the mouth to measure the retentive force. The aim of the study was to investigate the differences in the retentive force produced by denture adhesives for patients with dry mouth compared to other denture adhesives, to determine whether they provide sufficient retentive force in the oral cavity and whether there is a relationship between the level of oral wetness and saliva production and the effectiveness of the denture adhesives.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Confirmatory

Trial characteristics_2

Explanatory

Developmental phase

Not applicable

Primary outcomes

Retentive force of palatal plate at 30 minutes in each test sample.

Key secondary outcomes

1.Retentive force of the palatal plate at 0, 10 and 20 minutes in each test sample
2.oral moistness
3.Saliva volume in 10 minutes
4.Results of the usability questionnaire (VAS values)

Study type

Interventional

Basic design

Cross-over

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

No treatment

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

5

Purpose of intervention

Treatment

Type of intervention

Food	Device,equipment	Other

Interventions/Control_1

Before the start of the measurement, the oral moisture level was measured with an oral moisture meter (Mucus). Denture adhesive for dry mouth (Pittatto Kaiteki Gel) was applied to the inner surface of the palatal plate made for each participant and pressed into the oral cavity. The measurement time was set at the start of the application of the palatal plate, and the retentive force was measured by a digital force gauge every 10 minutes until 30 minutes after the application of the palatal plate. Retentive force was measured by pressure contact and traction. Measurements were repeated four times at each time point. Saliva secretion was also measured up to 10 minutes later. After the measurement, the participants were asked to rinse the palatal plate with water and completed a questionnaire for subjective evaluation using the Visual Analogue Scale.

Interventions/Control_2

Before the start of the measurement, the oral moisture level was measured with an oral moisture meter (Mucus). Denture adhesive (New poligurip) was applied to the inner surface of the palatal plate made for each participant and pressed into the oral cavity. The measurement time was set at the start of the application of the palatal plate, and the retentive force was measured by a digital force gauge every 10 minutes until 30 minutes after the application of the palatal plate. Retentive force was measured by pressure contact and traction. Measurements were repeated four times at each time point. Saliva secretion was also measured up to 10 minutes later. After the measurement, the participants were asked to rinse the palatal plate with water and completed a questionnaire for subjective evaluation using the Visual Analogue Scale.

Interventions/Control_3

Before the start of the measurement, the oral moisture level was measured with an oral moisture meter (Mucus). Oral moisturizer(Biotene Oral Balance Jell) was applied to the inner surface of the palatal plate made for each participant and pressed into the oral cavity. The measurement time was set at the start of the application of the palatal plate, and the retentive force was measured by a digital force gauge every 10 minutes until 30 minutes after the application of the palatal plate. Retentive force was measured by pressure contact and traction. Measurements were repeated four times at each time point. Saliva secretion was also measured up to 10 minutes later. After the measurement, the participants were asked to rinse the palatal plate with water and completed a questionnaire for subjective evaluation using the Visual Analogue Scale.

Interventions/Control_4

Before the start of the measurement, the oral moisture level was measured with an oral moisture meter (Mucus). Denture moisturizer(Denture Wet) was applied to the inner surface of the palatal plate made for each participant and pressed into the oral cavity. The measurement time was set at the start of the application of the palatal plate, and the retentive force was measured by a digital force gauge every 10 minutes until 30 minutes after the application of the palatal plate. Retentive force was measured by pressure contact and traction. Measurements were repeated four times at each time point. Saliva secretion was also measured up to 10 minutes later. After the measurement, the participants were asked to rinse the palatal plate with water and completed a questionnaire for subjective evaluation using the Visual Analogue Scale.

Interventions/Control_5

Before the start of the measurement, the oral moisture level was measured with an oral moisture meter (Mucus). The palatal plate was pressed into the oral cavity with no sample applied.The measurement time was set at the start of the application of the palatal plate, and the retentive force was measured by a digital force gauge every 10 minutes until 30 minutes after the application of the palatal plate. Retentive force was measured by pressure contact and traction. Measurements were repeated four times at each time point. Saliva secretion was also measured up to 10 minutes later.

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

Not applicable

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

Dentists belonging to the Department of Geriatric Dentistry, Showa University Dental Hospital, who have given written consent.

Key exclusion criteria

1. those who complained of poor physical condition on the day of impression taking or measurement
2. those with anatomical findings that interfere with measurements, such as large bony prominences
3. those with oral mucositis or other abnormal findings
4. those with a strong gag reflex, making it difficult to take impressions
5. those who use drugs that affect salivary secretion on the day of measurement.

Target sample size

15

Name of lead principal investigator

1st name	Osamu
Middle name
Last name	Shimodaira

Organization

Showa University Hospital

Division name

Department of Oral Function Management

Zip code

145-8515

Address

2-1-1 Kitasenzoku Ota Word Tokyo

TEL

03-3787-1151

Email

shimodaira@dent.showa-u.ac.jp

Name of contact person

1st name	Kunihitp
Middle name
Last name	Yamane

Organization

Showa University Hospital

Division name

Department of Oral Function Management

Zip code

145-8515

Address

2-1-1 Kitasenzoku Ota Word Tokyo

TEL

03-3787-1151

Homepage URL

Email

kyamane@dent.showa-u.ac.jp

Institute

Showa University Dental Hospital

Institute

Department

Personal name

Organization

Showa University Dental Hospital department of Oral Function Management

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Showa University Dental Hospital Clinical Trial Review Committee

Address

2-1-1 Kitasenzoku Ota Word Tokyo

Tel

03-3787-1151

Email

dh-ctrial@ofc.showa-u.ac.jp

Secondary IDs

YES

Study ID_1

SUDH0065

Org. issuing International ID_1

Showa University Dental Hospital Clinical Trial Review Committee

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

昭和大学歯科病院（東京都）

Date of disclosure of the study information

2022

Year

12

Month

19

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

10

Results

Results date posted

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

Participant flow

Adverse events

Outcome measures

Plan to share IPD

IPD sharing Plan description

Recruitment status

Suspended

Date of protocol fixation

2021

Year

02

Month

24

Day

Date of IRB

2021

Year

02

Month

24

Day

Anticipated trial start date

2021

Year

02

Month

27

Day

Last follow-up date

2023

Year

02

Month

28

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2022

Year

12

Month

16

Day

Last modified on

2023

Year

08

Month

21

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000056733