UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050616 |
|---|---|
| Receipt number | R000057654 |
| Scientific Title | Effect of complementary therapies on the gag reflex: A randomized, placebo-controlled, double-blind, crossover study |
| Date of disclosure of the study information | 2023/03/17 |
| Last modified on | 2025/09/04 13:07:49 |
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Basic information
Public title
Effect of complementary therapies on the gag reflex
Acronym
Effect of complementary therapies on the gag reflex
Scientific Title
Effect of complementary therapies on the gag reflex: A randomized, placebo-controlled, double-blind, crossover study
Scientific Title:Acronym
Effect of complementary therapies on the gag reflex
Region
| Japan |
Condition
Condition
Individuals with severe gag reflex during dental procedures
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate whether complementary therapies reduces gag reflex during dental procedures
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
insertion distance of saliva ejector
after intervention of complementary therapy
Key secondary outcomes
Pulse rate, Galvanic skin response
after intervention of complementary therapy
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver | Other |
Interventions/Control_1
Aromatherapy with peppermint essential oil or distilled water (5 min), Washout period, Aromatherapy with distilled water or peppermint essential oil (5 min)
Interventions/Control_2
Acupressure on pericardium 6 or sham point (20 min), Washout period, Acupressure on sham point or pericardium 6 (20 min)
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
Healthy adults who have received dental treatment
Key exclusion criteria
We excluded those with 1) mental illness, physical disease, or oral disease; 2) dentures; 3) a history of eustachian tube obstruction, nasal obstruction, pneumothorax, or intestinal obstruction; and 4) medications that may affect autonomic nerve activity.
Target sample size
17
Research contact person
Name of lead principal investigator
| 1st name | Hiroyuki |
| Middle name | |
| Last name | Karibe |
Organization
The Nippon Dental University, School of Life Dentistry at Tokyo
Division name
Department of Pediatric Dentistry
Zip code
102-8159
Address
1-9-20 Fujimi Chiyoda-ku
TEL
03-3261-5757
h-karibe@tky.ndu.ac.jp
Public contact
Name of contact person
| 1st name | Ayuko |
| Middle name | |
| Last name | Okamoto |
Organization
The Nippon Dental University, School of Life Dentistry at Tokyo
Division name
Department of Pediatric Dentistry
Zip code
102-8159
Address
1-9-20 Fujimi Chiyoda-ku
TEL
03-3261-5757
Homepage URL
okamotoa@tky.ndu.ac.jp
Sponsor or person
Institute
The Nippon Dental University, School of Life Dentistry at Tokyo
Institute
Department
Personal name
Funding Source
Organization
Scientific Research from the Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The Ethics Committee of Nippon Dental University, School of Life Dentistry
Address
1-9-20 Fujimi Chiyoda-ku
Tel
03-3261-8311
ndu-rinri@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
| 2023 | Year | 03 | Month | 17 | Day |
Related information
URL releasing protocol
https://pubmed.ncbi.nlm.nih.gov/38281005/
Publication of results
Partially published
Result
URL related to results and publications
https://pubmed.ncbi.nlm.nih.gov/38281005/
Number of participants that the trial has enrolled
24
Results
This study evaluated both aromatherapy with peppermint essential oil and acupressure on pericardium 6. Results for aromatherapy with peppermint essential oil have been published previously. Results for acupressure on pericardium 6 are reported separately.
Results date posted
| 2025 | Year | 09 | Month | 04 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Twenty-four healthy Japanese adults (12 females, 12 males; average age 34.3 years) who consented to participate in the study were selected. The eligibility criteria for the participants were as follows: (1) adults aged 20 to 50 years, (2) history of previous dental treatment, and (3) no serious medical history. We excluded participants with (1) mental illness, physical disease, or oral disease; (2) dentures; (3) a history of eustachian tube obstruction, nasal obstruction, pneumothorax, or intestinal obstruction; and (4) medication prescriptions that may affect autonomic nerve activity.
Participant flow
All participants were recruited from the surrounding areas through websites. They were given an honorarium after completion of the study.
Adverse events
No adverse events were observed in any of the participants.
Outcome measures
Gag reflex value defined as the insertion distance of the saliva ejector, pulse rate, and galvanic skin response
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2016 | Year | 08 | Month | 04 | Day |
Date of IRB
| 2016 | Year | 09 | Month | 29 | Day |
Anticipated trial start date
| 2019 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 03 | Month | 17 | Day |
Last modified on
| 2025 | Year | 09 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057654
