Impact of Energy Drinks on the Manual Dexterity of Final Year Dental Students

NCT02535143 | Completed Phase 4 DMC

• 1 other identifier: FUGRP/2014/183.
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hand Skill, Relative

Outcome Measures

Primary Outcomes (1)

• Cavity Accuracy in mm

  Accuracy of the test cavity prepared in mm

  Immediate

Secondary Outcomes (1)

• Time taken to prepare the cavity in seconds

  immediate

Study Arms (2)

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.

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.

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

Interventions

Test Cavity Preparation OTHER

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

Also known as: Dexterity test

Control Group; Test Group

Taurine DRUG

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

Also known as: Energy Drink

Test Group

Post intervention test cavity OTHER

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

Control Group; Test Group

Carbonated Apple Juice DIETARY_SUPPLEMENT

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

Also known as: Appy FIzz (Parle Agro, India)

Control Group

Eligibility Criteria

• Age: 21 Years - 26 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Final year dental student
• Able to prepare acceptable test cavity (2mmx2mmx2mm) prior to intervention

You may not qualify if:

• Smokers
• Women on Oral Contraceptives
• History of Renal Disease

Sponsors & Collaborators

• Riyadh Colleges of Dentistry and Pharmacy: lead

Study Sites (1)

Riyadh Colleges of Dentistry and Pharmacy

Riyadh, Saudi Arabia

Location

Related 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.

  PMID: 24648821 BACKGROUND

• 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.

  PMID: 23272423 BACKGROUND

• 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. doi: 10.1111/j.1399-6576.2007.01527.x. Epub 2007 Nov 14.

  PMID: 18005374 BACKGROUND

• 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(0 1):87-97. doi: 10.1111/nure.12129.

  PMID: 25293548 BACKGROUND

• 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.

  PMID: 24502849 BACKGROUND

• GOLDBERG 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.

  PMID: 20982931 BACKGROUND

• 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.

  PMID: 25331270 BACKGROUND

• 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. doi: 10.1007/s10900-013-9749-y.

  PMID: 23959655 BACKGROUND

MeSH Terms

Interventions

Taurine; Energy Drinks

Intervention Hierarchy (Ancestors)

Alkanesulfonic Acids; Alkanes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Sulfonic Acids; Sulfur Acids; Sulfur Compounds; Beverages; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Hezekiah A Mosadomi, DMD

  Riyadh Colleges of Dentistry and Pharmacy

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: August 26, 2015
• First Posted: August 28, 2015
• Study Start: September 1, 2014
• Primary Completion: December 1, 2014
• Study Completion: July 1, 2015
• Last Updated: October 12, 2016

Record last verified: 2016-10

Data Sharing

• IPD Sharing: Will not share

Locations

SA (1)