Effects of brushing with caffeinated toothpaste on cognitive and motor responses of the central nervous system: A pilot study

Investigating the effect of brushing with caffeinated toothpaste on cognitive and motor responses of the central nervous system

A clinical trial with a control group, with a placebo, a sample size of 75, double-blind, phase 3, randomized, RAND function in Excel is used for randomization.

During a public call, volunteers are invited to Fasa University of Medical Sciences. After explaining the study and receiving the informed consent, each person will be given a package containing a toothbrush, capsule and toothpaste. In the first phase, 50 people, including 5 groups of 10 people, will only take neuro-cognitive computer tests. In the second phase, 25 people, including 5 groups of 5 people, will measure the serum caffeine level.

Criteria for entering the study: 1) Healthy subjects with informed consent to participate in the study 2) Absence of addiction to drugs, alcohol and tobacco 3) Not consuming coffee and painkillers containing caffeine, nerve agents, tea and drinks that can affect the tests, from 48 hours before. People who do not have: 4) cognitive impairment. 5) mental disorder. 6) cardiovascular diseases. 7) neurological disorders. 8) thyroid disorders. 9) mouth and mucous diseases. Exclusion criteria: 1) Any reaction or sensitivity to caffeine

1. Receiving placebo capsule and toothbrush with control toothpaste 2. Receiving 100 mg caffeine capsule and toothbrush with control toothpaste 3. Receiving placebo capsule and toothbrush with caffeinated toothpaste 100 mg in 2 minutes 4. Receiving placebo capsule and toothbrush with caffeinated toothpaste 100 mg in 3 minutes 5.Receiving placebo capsule and toothbrush with 100 mg caffeinated toothpaste in 4 minutes

Selective attention capacity, Selective processing speed, Short-Term Memory and Hand Eye Coordination, serum caffeine

The randomization of people is done based on the permutation of five random blocks, and the random sequence based on this method will be done by lottery using a table of random numbers.

Blocking and allocation sequence for concealment will be done by a person not involved in the research. The shape and packaging of the capsules and toothpaste will be the same so that the researchers and participants will not be aware of the package (one capsule and one toothpaste) of each person. Only the person responsible for packaging the drugs will know the numbers of the respective envelopes, and none of the researchers or participants will know the contents of the package that each person receives. Packages will be placed in A, B, C, D and E envelopes by a person as a coder. Patients will not be aware of the assignment of codes to package envelopes, and the researchers who will provide the packages to the people at the place of implementation of the plan will not be aware of the contents of the packages and the allocation of people to five groups.

Demographic information and clinical trial results

3 months after the publication of the article, it will be possible to access the data.

Researchers in all universities of medical sciences

Researchers can submit their request to the Vice-Chancellor of Research and Technology and the Ethics Committee of Fasa University of Medical Sciences, and if they agree, the data will be provided to them.

Fasa University of Medical Sciences, Vice President of Research and Technology

Approval of the Research and Technology Vice-Chancellor and Ethics Committee of Fasa University of Medical Sciences