Hand Skill, RelativePhase 4NCT02535143
Impact of Energy Drinks on the Manual Dexterity of Final Year Dental Students
A Phase 4 study testing Test Cavity Preparation, Taurine and Post intervention test cavity in people with Hand Skill, Relative, run by Riyadh Colleges of Dentistry and Pharmacy at 1 site in Saudi Arabia.
Trial summary
This study aims to test the hypothesis that there was a relationship between the consumption of energy drinks and the manual dexterity skills of final year dental students. Identification of baseline caffeine consumption and selection of sample Baseline caffeine consumption will be identified by distributing the… Read more about this study
- Who is it for?
- Ages 21 to 26 yearsHealthy volunteers can take part
- Conditions the study is for
- Hand Skill, Relative
- What is being tested?
- Test Cavity Preparation, Taurine and Post intervention test cavity
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- Sep 2014to Jul 2015
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 26 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Final year dental student
- Able to prepare acceptable test cavity (2mmx2mmx2mm) prior to intervention
Who cannot join
- Smokers
- Women on Oral Contraceptives
- History of Renal Disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Impact of Energy Drinks on the Manual Dexterity of Final Year Dental Students
This study aims to test the hypothesis that there was a relationship between the consumption of energy drinks and the manual dexterity skills of final year dental students.
Identification of baseline caffeine consumption and selection of sample Baseline caffeine consumption will be identified by distributing the caffeine consumption questionnaire to all the final year students of the Riyadh Colleges of Dentistry and Pharmacy. The study will recruit 60 students who are moderate caffeine consumers. To avoid the confounding effect of nicotine consumption, the study will only recruit non-smokers .female candidates taken oral contraceptives and Subjects with any history of renal disease will be excluded.
Read more
All subjects will be required to prepare a box 2mmx2mmx2mm using a high speed handpiece (NSK, Japan) and a no.330 cutting bur. Each participant will be allowed two attempts to cut the cavity in each test both cavities will be selected for assessment. The ability of the participants to reproduce the dimensions (2mmx2mmx2mm) and the time taken to complete the task will be used as criteria to evaluate dexterity. The participants will be required to perform the test before and 30 minutes after energy drink exposure.
Energy Drink Exposure Subjects will be given 330ml of an energy three hours after the last meal in the other hand the control group will be receiving a placebo drink .
Dexterity outcomes will be compared before and after exposure to the energy drink using the paired t test. Outcomes will be compared between different groups and different time intervals using the two way, multiple measures ANOVA. All data will be analyzed using the SPSS ver.21 data processing software.
Read the detailed description
The dentistry training program has been reported to be a stressful one; and while academic pressures are high, the high level of dexterity skills that dentistry demands are often cited as a major source of stress. There is some research on the impact that caffeine in general and energy drinks in particular can have on academic performance, however, there is considerably less data on the impact of these drinks on manual dexterity. This study aims to test the hypothesis that there was a relationship between the consumption of energy drinks and the manual dexterity skills of final year dental students.
Identification of baseline caffeine consumption and selection of sample Baseline caffeine consumption will be identified by distributing the caffeine consumption questionnaire to all the final year students of the Riyadh Colleges of Dentistry and Pharmacy. Based on the caffeine consumption score the study will recruit 60 moderate. To avoid the confounding effect of nicotine consumption, the study will only recruit non-smokers .female candidates taken oral contraceptives will be eliminated due to the correlation between them and caffeine. Subjects with any history of renal disease will be prevented from participation in the study Test for manual dexterity Acrylic blocks (2cmx2cmx2cm) will be prepared using a standardized mold. All subjects will be required to prepare a box 2mmx2mmx2mm using a high speed handpiece (NSK, Japan) and a no.330 cutting bur. Each participant will be allowed two attempts to cut the cavity in each test both cavities will be selected for assessment. The ability of the participants to reproduce the dimensions (2mmx2mmx2mm) and the time taken to complete the task will be used as criteria to evaluate dexterity. The participants will be required to perform the test before and 30 minutes after energy drink exposure.
Energy Drink Exposure Subjects in the test group (n 30) will be given 330ml of an energy drink containing caffeine, sugar and taurine (Red Bull, Red Bull GmbH, Austria Vienna) three hours after the last meal in the other hand the control group (n30) will be receiving a placebo drink which is apple juice.
Statistical Analysis Dexterity outcomes will be compared before and after exposure to the energy drink using the paired t test. Outcomes will be compared between different groups and different time intervals using the two way, multiple measures ANOVA. All data will be analyzed using the SPSS ver.21 data processing software.
- Conditions
- Hand Skill, Relative
- Being tested
- Test Cavity Preparation, Taurine, Post intervention test cavity, Carbonated Apple Juice
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Test Cavity PreparationOther
Also called Dexterity test
Subjects will be asked to prepare a cavity 2mmx 2mmx 2mm in an acrylic block using an airotor and a tungsten carbide bur prior to consuming the test drink
TaurineDrug
Also called Energy Drink
250 ml of commercially available taurine containing energy drink to be administered three hours after the last meal and half an hour prior to performing the second test cavity
Post intervention test cavityOther
Subjects will be asked to prepare a cavity 2mmx 2mmx 2mm in an acrylic block 30 minutes after consuming the intervention drink using an airotor and a tungsten carbide bur prior to consuming the test drink
Carbonated Apple JuiceDietary supplement
Also called Appy FIzz (Parle Agro, India)
250ml of commercially available carbonated apple juice to be administered three hours after the last meal and half an hour prior to performing the second test cavity
| Study group | Role | What they receive |
|---|---|---|
| Test Group | Experimental | Group will prepare a test cavity in an acrylic block. They will receive 250 ml of a commercially available energy drink containing caffeine and taurine (Red Bull, Red Bull GmBh Austria) three hours after the last meal. The participants will then be required to perform a post intervention test cavity preparation 30 minutes after consuming the drink. Receives: Other: Test Cavity Preparation; Drug: Taurine; Other: Post intervention test cavity |
| Control Group | Placebo comparator | Group will prepare a test cavity in an acrylic block. They will receive 250ml of a commercially available carbonated apple juice (Appy Fizz, Parle Agro, Mumbai, India) three hours after the last meal. The participants will then be required to perform a post intervention test cavity preparation 30 minutes after consuming the drink. Receives: Other: Test Cavity Preparation; Other: Post intervention test cavity; Dietary Supplement: Carbonated Apple Juice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cavity Accuracy in mm
Accuracy of the test cavity prepared in mm
Measured: Immediate
Secondary outcomes (1)
Time taken to prepare the cavity in seconds
Time taken in seconds to prepare the test cavity
Measured: immediate
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2015 (estimated)
- Study startSep 2014
- Primary completionDec 2014
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Hand Skill, RelativeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riyadh Colleges of Dentistry and Pharmacy
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Sharat Pani, Riyadh Colleges of Dentistry and Pharmacy
- Investigators
- Hezekiah A Mosadomi, DMD, Study chair, Riyadh Colleges of Dentistry and Pharmacy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02535143
- Sponsor's protocol ID
- FUGRP/2014/183.
- Status last verified
- Oct 2016
- First submitted
- 26 Aug 2015
- Last updated
- 12 Oct 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Almalak H, Albluwi AI, Alkhelb DA, Alsaleh HM, Khan TM, Hassali MA, Aljadhey H. Students' attitude toward use of over the counter medicines during exams in Saudi Arabia. Saudi Pharm J. 2014 Apr;22(2):107-12. doi: 10.1016/j.jsps.2013.02.004. Epub 2013 Mar 21.
PubMed 24648821Alsunni AA, Badar A. Energy drinks consumption pattern, perceived benefits and associated adverse effects amongst students of University of Dammam, Saudi Arabia. J Ayub Med Coll Abbottabad. 2011 Jul-Sep;23(3):3-9.
PubMed 23272423Arai YC, Kandatsu N, Ito H, Sato Y, Satake Y, Mizutani M, Ushida T, Komatsu T. Induction and emergence behavior of children undergoing general anesthesia correlates with maternal salivary amylase activity before the anesthesia. Acta Anaesthesiol Scand. 2008 Feb;52(2):285-8. doi: 10.1111/j.1399-6576.2007.01527.x. Epub 2007 Nov 14.
PubMed 18005374Arria AM, Bugbee BA, Caldeira KM, Vincent KB. Evidence and knowledge gaps for the association between energy drink use and high-risk behaviors among adolescents and young adults. Nutr Rev. 2014 Oct;72 Suppl 1(0 1):87-97. doi: 10.1111/nure.12129.
PubMed 25293548Azagba S, Langille D, Asbridge M. An emerging adolescent health risk: caffeinated energy drink consumption patterns among high school students. Prev Med. 2014 May;62:54-9. doi: 10.1016/j.ypmed.2014.01.019. Epub 2014 Feb 4.
PubMed 24502849GOLDBERG AA, JEFFERIES HS. Potentiation of insulin hypoglycaemia by nicotinyl taurine (beta-nicotinamidoethanesulphonic acid). Q J Pharm Pharmacol. 1946 Jan-Mar;19:48-53. No abstract available.
PubMed 20982931Pai KM, Kamath A, Goel V. Effect of Red Bull energy drink on muscle performance: an electromyographic overview. J Sports Med Phys Fitness. 2015 Dec;55(12):1459-65. Epub 2014 Oct 21.
PubMed 25331270Spierer DK, Blanding N, Santella A. Energy drink consumption and associated health behaviors among university students in an urban setting. J Community Health. 2014 Feb;39(1):132-8. doi: 10.1007/s10900-013-9749-y.
PubMed 23959655
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Energy Drinks on the Manual Dexterity of Final Year Dental Students
- ClinicalTrials.gov ID
- NCT02535143
- Acronym / sponsor ID
- FUGRP/2014/183.
- Conditions
- Hand Skill, Relative
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Riyadh Colleges of Dentistry and PharmacyUniversity, hospital or other
- Study start
- Sep 2014
- Primary completion
- Dec 2014 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 28 Aug 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to test the hypothesis that there was a relationship between the consumption of energy drinks and the manual dexterity skills of final year dental students.
Identification of baseline caffeine consumption and selection of sample Baseline caffeine consumption will be identified by distributing the caffeine consumption questionnaire to all the final year students of the Riyadh Colleges of Dentistry and Pharmacy. The study will recruit 60 students who are moderate caffeine consumers. To avoid the confounding effect of nicotine consumption, the study will only recruit non-smokers .female candidates taken oral contraceptives and Subjects with any history of renal disease will be excluded.
All subjects will be required to prepare a box 2mmx2mmx2mm using a high speed handpiece (NSK, Japan) and a no.330 cutting bur. Each participant will be allowed two attempts to cut the cavity in each test both cavities will be selected for assessment. The ability of the participants to reproduce the dimensions (2mmx2mmx2mm) and the time taken to complete the task will be used as criteria to evaluate dexterity. The participants will be required to perform the test before and 30 minutes after energy drink exposure.
Energy Drink Exposure Subjects will be given 330ml of an energy three hours after the last meal in the other hand the control group will be receiving a placebo drink .
Dexterity outcomes will be compared before and after exposure to the energy drink using the paired t test. Outcomes will be compared between different groups and different time intervals using the two way, multiple measures ANOVA. All data will be analyzed using the SPSS ver.21 data processing software.
Detailed description
The dentistry training program has been reported to be a stressful one; and while academic pressures are high, the high level of dexterity skills that dentistry demands are often cited as a major source of stress. There is some research on the impact that caffeine in general and energy drinks in particular can have on academic performance, however, there is considerably less data on the impact of these drinks on manual dexterity. This study aims to test the hypothesis that there was a relationship between the consumption of energy drinks and the manual dexterity skills of final year dental students.
Identification of baseline caffeine consumption and selection of sample Baseline caffeine consumption will be identified by distributing the caffeine consumption questionnaire to all the final year students of the Riyadh Colleges of Dentistry and Pharmacy. Based on the caffeine consumption score the study will recruit 60 moderate. To avoid the confounding effect of nicotine consumption, the study will only recruit non-smokers .female candidates taken oral contraceptives will be eliminated due to the correlation between them and caffeine. Subjects with any history of renal disease will be prevented from participation in the study Test for manual dexterity Acrylic blocks (2cmx2cmx2cm) will be prepared using a standardized mold. All subjects will be required to prepare a box 2mmx2mmx2mm using a high speed handpiece (NSK, Japan) and a no.330 cutting bur. Each participant will be allowed two attempts to cut the cavity in each test both cavities will be selected for assessment. The ability of the participants to reproduce the dimensions (2mmx2mmx2mm) and the time taken to complete the task will be used as criteria to evaluate dexterity. The participants will be required to perform the test before and 30 minutes after energy drink exposure.
Energy Drink Exposure Subjects in the test group (n 30) will be given 330ml of an energy drink containing caffeine, sugar and taurine (Red Bull, Red Bull GmbH, Austria Vienna) three hours after the last meal in the other hand the control group (n30) will be receiving a placebo drink which is apple juice.
Statistical Analysis Dexterity outcomes will be compared before and after exposure to the energy drink using the paired t test. Outcomes will be compared between different groups and different time intervals using the two way, multiple measures ANOVA. All data will be analyzed using the SPSS ver.21 data processing software.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test Group | Experimental | Other: Test Cavity Preparation, Drug: Taurine, Other: Post intervention test cavityGroup will prepare a test cavity in an acrylic block. They will receive 250 ml of a commercially available energy drink containing caffeine and taurine (Red Bull, Red Bull GmBh Austria) three hours after the last meal. The participants will then be required to perform a post intervention test cavity preparation 30 minutes after consuming the drink. |
| Control Group | Placebo comparator | Other: Test Cavity Preparation, Other: Post intervention test cavity, Dietary Supplement: Carbonated Apple JuiceGroup will prepare a test cavity in an acrylic block. They will receive 250ml of a commercially available carbonated apple juice (Appy Fizz, Parle Agro, Mumbai, India) three hours after the last meal. The participants will then be required to perform a post intervention test cavity preparation 30 minutes after consuming the drink. |
Who may qualify
- Ages
- 21 to 26 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Final year dental student
- Able to prepare acceptable test cavity (2mmx2mmx2mm) prior to intervention
Key exclusion criteria (3 listed)
- Smokers
- Women on Oral Contraceptives
- History of Renal Disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Test Cavity PreparationAlso: Dexterity testSubjects will be asked to prepare a cavity 2mmx 2mmx 2mm in an acrylic block using an airotor and a tungsten carbide bur prior to consuming the test drink | Other | Control Group, Test Group |
| TaurineAlso: Energy Drink250 ml of commercially available taurine containing energy drink to be administered three hours after the last meal and half an hour prior to performing the second test cavity | Drug | Test Group |
| Post intervention test cavitySubjects will be asked to prepare a cavity 2mmx 2mmx 2mm in an acrylic block 30 minutes after consuming the intervention drink using an airotor and a tungsten carbide bur prior to consuming the test drink | Other | Control Group, Test Group |
| Carbonated Apple JuiceAlso: Appy FIzz (Parle Agro, India)250ml of commercially available carbonated apple juice to be administered three hours after the last meal and half an hour prior to performing the second test cavity | Dietary supplement | Control Group |
Primary outcome
Cavity Accuracy in mm
Time frame: Immediate
Accuracy of the test cavity prepared in mm
1 secondary outcome
Time taken to prepare the cavity in seconds
Time frame: immediate
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2016.
- Background: PubMed 24648821Almalak H, Albluwi AI, Alkhelb DA, Alsaleh HM, Khan TM, Hassali MA, Aljadhey H. Students' attitude toward use of over the counter medicines during exams in Saudi Arabia. Saudi Pharm J. 2014 Apr;22(2):107-12. doi: 10.1016/j.jsps.2013.02.004. Epub 2013 Mar 21.
- Background: PubMed 23272423Alsunni AA, Badar A. Energy drinks consumption pattern, perceived benefits and associated adverse effects amongst students of University of Dammam, Saudi Arabia. J Ayub Med Coll Abbottabad. 2011 Jul-Sep;23(3):3-9.
- Background: PubMed 18005374Arai YC, Kandatsu N, Ito H, Sato Y, Satake Y, Mizutani M, Ushida T, Komatsu T. Induction and emergence behavior of children undergoing general anesthesia correlates with maternal salivary amylase activity before the anesthesia. Acta Anaesthesiol Scand. 2008 Feb;52(2):285-8. doi: 10.1111/j.1399-6576.2007.01527.x. Epub 2007 Nov 14.
- Background: PubMed 25293548Arria AM, Bugbee BA, Caldeira KM, Vincent KB. Evidence and knowledge gaps for the association between energy drink use and high-risk behaviors among adolescents and young adults. Nutr Rev. 2014 Oct;72 Suppl 1(0 1):87-97. doi: 10.1111/nure.12129.
- Background: PubMed 24502849Azagba S, Langille D, Asbridge M. An emerging adolescent health risk: caffeinated energy drink consumption patterns among high school students. Prev Med. 2014 May;62:54-9. doi: 10.1016/j.ypmed.2014.01.019. Epub 2014 Feb 4.
- Background: PubMed 20982931GOLDBERG AA, JEFFERIES HS. Potentiation of insulin hypoglycaemia by nicotinyl taurine (beta-nicotinamidoethanesulphonic acid). Q J Pharm Pharmacol. 1946 Jan-Mar;19:48-53. No abstract available.
- Background: PubMed 25331270Pai KM, Kamath A, Goel V. Effect of Red Bull energy drink on muscle performance: an electromyographic overview. J Sports Med Phys Fitness. 2015 Dec;55(12):1459-65. Epub 2014 Oct 21.
- Background: PubMed 23959655Spierer DK, Blanding N, Santella A. Energy drink consumption and associated health behaviors among university students in an urban setting. J Community Health. 2014 Feb;39(1):132-8. doi: 10.1007/s10900-013-9749-y.
- Individual participant dataSharing planned: No
Related trials for Hand Skill, Relative
Not yet recruitingObservational study
Relation Between Autistic Features and Fine Motor Abilities in Children With Autism Spectrum Disorder
Autism or Autistic Traits
Recruiting
Correlation of STN-DBS Induced Visuospatial Changes and Freezing of Gait
Parkinson Disease, Gait Disorders, Neurologic
Not yet recruitingObservational study
Comparison of Upper Extremity Functions of Physiotherapy Students
Handedness and Upper Extremity Function
RecruitingObservational study
Molecular Genetics of Heterotaxy and Related Congenital Heart Defects
Heterotaxy Syndrome, Congenital Heart Defects
RecruitingObservational study
Influence of Handedness on Upper Limb Recovery
Stroke
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hezekiah A Mosadomi, DMD study chair
Riyadh Colleges of Dentistry and Pharmacy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Test Cavity Preparation, Taurine and Post intervention test cavity in people with Hand Skill, Relative, run by Riyadh Colleges of Dentistry and Pharmacy at 1 site in Saudi Arabia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Saudi Arabia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cavity Accuracy in mm (time frame: Immediate). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02535143, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Oct 2016.