UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055891 |
|---|---|
| Receipt number | R000063868 |
| Scientific Title | Impact of Coffee Consumption on Local Anesthesia Effectiveness in Dental Treatment: A Cross-over Trial |
| Date of disclosure of the study information | 2024/10/21 |
| Last modified on | 2024/10/21 07:19:47 |
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Basic information
Public title
Impact of Coffee Consumption on Local Anesthesia Effectiveness in Dental Treatment: A Cross-over Trial
Acronym
COFFEEANESTHESIA
Scientific Title
Impact of Coffee Consumption on Local Anesthesia Effectiveness in Dental Treatment: A Cross-over Trial
Scientific Title:Acronym
COFFEEANESTHESIA
Region
| Asia(except Japan) |
Condition
Condition
This study evaluated the impact of coffee consumption on the effectiveness and onset time of local anesthesia (LA) in healthy adults, using the Electric Pulp Test (EPT) as a measure of pulpal anesthesia.
Classification by specialty
| Dental medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study evaluated the impact of coffee consumption on the effectiveness and onset time of local anesthesia (LA) in healthy adults, using the Electric Pulp Test (EPT) as a measure of pulpal anesthesia.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Coffee consumption does not affect the effectiveness or onset time of local anesthesia in healthy adults.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -investigator(s) and assessor(s) are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Food |
Interventions/Control_1
This study was a single-blinded crossover clinical trial where the same participants served as both the intervention and control groups. Each participant experienced both the intervention (drinking one cup of coffee) and the control (no coffee) within a month.
Interventions/Control_2
This study was a single-blinded crossover clinical trial where the same participants served as both the intervention and control groups. Each participant experienced both the intervention (drinking one cup of coffee) and the control (no coffee) within a month.
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
| 18 | years-old | <= |
Age-upper limit
| 20 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
We excluded individuals who were overweight or obese. We excluded those who consumed coffee in high doses ( 6 cups or more daily, more than 450 mg caffeine daily). We also excluded individuals who did not consume coffee at all.
Key exclusion criteria
Participants were healthy adults aged 18-30 years with intact upper premolars confirmed clinically and radiographically
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Abdullah Abdulrahman |
| Middle name | |
| Last name | Marghalani |
Organization
Umm Al-Qura University
Division name
Department of Preventive Dentistry, ollege of Dental Medicine
Zip code
24382
Address
Department of Preventive Dentistry, College of Dental Medicine, Umm Al-Qura University, Makkah, Saudi Arabia
TEL
00966531355414
aamarghalani@uqu.edu.sa
Public contact
Name of contact person
| 1st name | Ahmed |
| Middle name | A. |
| Last name | Alabdrabalnabi |
Organization
Saudi Electronic University
Division name
Public Health
Zip code
32256
Address
Ar Rayyan Dist. Colleges Campus
TEL
00966565255523
Homepage URL
a.alabdrabalnabi@seu.edu.sa
Sponsor or person
Institute
Department of Preventive Dentistry, College of Dental Medicine, Umm Al-Qura University
Institute
Department
Personal name
Abdullah A. Marghalani
Funding Source
Organization
Self-funded
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Umm Al-Qura University, Makkah, Saudi Arabia
Address
Umm Al-Qura University, Makkah, Saudi Arabia
Tel
966125270000
dsr@uqu.edu.sa
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
Department of Preventive Dentistry, College of Dental Medicine, Umm Al-Qura University, Makkah, Saudi Arabia
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 10 | Month | 21 | 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
10
Results
The study found no significant difference in the effectiveness of LA between the coffee and no coffee groups. Both groups achieved complete pulpal anesthesia as indicated by maximum EPT readings of 64. The duration to achieve numbness after LA administration was consistent at two minutes across both groups.
Results date posted
| 2024 | Year | 10 | Month | 21 | Day |
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
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2024 | Year | 03 | Month | 18 | Day |
Date of IRB
| 2024 | Year | 03 | Month | 17 | Day |
Anticipated trial start date
| 2024 | Year | 10 | Month | 25 | Day |
Last follow-up date
| 2024 | Year | 11 | Month | 25 | 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 | 10 | Month | 21 | Day |
Last modified on
| 2024 | Year | 10 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063868
