Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02535143
Other study ID # FUGRP/2014/183.
Secondary ID
Status Completed
Phase Phase 4
First received August 26, 2015
Last updated October 11, 2016
Start date September 2014
Est. completion date July 2015

Study information

Verified date October 2016
Source Riyadh Colleges of Dentistry and Pharmacy
Contact n/a
Is FDA regulated No
Health authority Saudi Arabia: Ministry for Higher Education
Study type Interventional

Clinical 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 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date July 2015
Est. primary completion date December 2014
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 21 Years to 26 Years
Eligibility Inclusion Criteria:

- Final year dental student

- Able to prepare acceptable test cavity (2mmx2mmx2mm) prior to intervention

Exclusion Criteria:

- Smokers

- Women on Oral Contraceptives

- History of Renal Disease

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Diagnostic


Related Conditions & MeSH terms


Intervention

Other:
Test Cavity Preparation
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
Drug:
Taurine
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
Other:
Post intervention test cavity
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
Dietary Supplement:
Carbonated Apple Juice
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

Locations

Country Name City State
Saudi Arabia Riyadh Colleges of Dentistry and Pharmacy Riyadh

Sponsors (1)

Lead Sponsor Collaborator
Riyadh Colleges of Dentistry and Pharmacy

Country where clinical trial is conducted

Saudi Arabia, 

References & Publications (8)

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. — View Citation

Alsunni 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. — View Citation

Arai 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. Epub 2007 Nov 14. — View Citation

Arria 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 1:87-97. doi: 10.1111/nure.12129. Review. — View Citation

Azagba 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. — View Citation

GOLDBERG AA, JEFFERIES HS. Potentiation of insulin hypoglycaemia by nicotinyl taurine (beta-nicotinamidoethanesulphonic acid). Q J Pharm Pharmacol. 1946 Jan-Mar;19:48-53. — View Citation

Pai 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. — View Citation

Spierer 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Cavity Accuracy in mm Accuracy of the test cavity prepared in mm Immediate No
Secondary Time taken to prepare the cavity in seconds Time taken in seconds to prepare the test cavity immediate No