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Completed

NCT Number: NCT03515902

The Effects of Mouthguard and Desensitizing Toothpaste in Reducing Dental Hypersensitivity

Tooth hypersensitivity due to dental erosion is one of the most common problem related to swimming in improper pH chlorinated pools. Because the teeth are exposed to acidic water for a long time, which cause the loss of dental hard tissue. Tooth hypersensitivity can lead to a negative effect on daily life such as dietary selection, maintaining optimal dental hygiene and beauty aspects. It has been found that using mouthguard while swimming can prevent the teeth directly contact to chlorinated water, so it can protect tooth structure and decrease tooth hypersensitivity. Moreover, using mouthguard with viscous products can seal the gaps between mouthguard and teeth which can help to protect tooth structure and decrease dental hypersensitivity more effectively. At present, there are many desensitizing products such as toothpaste, mouthwash and chewing gum. Desensitizing toothpaste is the most common over-the-counter (OTC) materials in desensitizing. Many research has endorsed the properties of desensitizing toothpaste that can reduce tooth tissue loss and helps to reduce tooth hypersensitivity effectively. So it can be hypothesize that when use the combination of mouthguard with desensitizing toothpaste, it might have synergistic effect on reducing tooth hypersensitivity in swimmers.

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Key information

Conditions

Dentine Hypersensitivity Dentin Sensitivity Stomatognathic Diseases Tooth Demineralization Tooth Diseases Tooth Erosion Tooth Wear

Age range

13 year–25 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Dentistry , Khon Kaen University

Khon Kaen, 40002, Thailand

About this study

Tooth erosion is the loss of dental hard tissue due to acidic agents without bacteria involvement.

Mouthguard is a protective appliance use for covering the teeth and gums to prevent the teeth from acidic chlorinated water.

Desensitizing toothpaste is toothpaste containing 8 percent arginine and calcium carbonate that can reduce tooth demineralization and promote remineralization.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 13-25 years (age under 18 years must obtain consent from parents)
  • Swimming at least 5 hours/week
  • Having tooth hypersensitivity from erosion
  • Can read or understand Thai language

Exclusion criteria

  • History of allergic to toothpaste
  • Having any tooth which will affect to the tightness of mouthguard
  • Having fixed orthodontic appliance

Treatment and study plan

Mouthguard

Device

mouthguard

mouthguard with desensitizing toothpaste

Device

mouthguard with desensitizing toothpaste containing 8% arginine with calcium carbonate

Primary outcomes

  1. Tooth hypersensitivity changes after using mouthguard with/without desensitizing toothpaste

    Time frame: baseline,2,4 and 8 weeks

    • Tooth hypersensitivity changes will be measured by the mean difference of visual analog scale (VAS) score at baseline,2,4 and 8 weeks by using 2 clinical stimuli including tactile and cold stimulation. Each stimulation will be measured and separately recorded as follow :

    1.Tactile stimulation

    • The score range from 0 (no tooth hypersensitivity) to 100 (worst possibly tooth hypersensitivity)
    • The mean difference of tooth hypersensitivity from tactile stimulation at any time point will be analyzed.
    • Cold stimulation
    • The score range from 0 (no tooth hypersensitivity) to 100 (worst possibly tooth hypersensitivity)
    • The mean difference of tooth hypersensitivity from cold stimulation at any time point will be analyzed.

Secondary outcomes

  1. The attitude and satisfaction of using mouthguard with/without desensitizing toothpaste

    Time frame: 2,4 and 8 weeks

    • The attitude and satisfaction will be collected by a self-administered questionnaire and interview at 2,4 and 8 weeks
    • The score range from 0 (no satisfying) to 100 (most satisfying)
    • The mean score of satisfying at any time point will be analyzed.

Other outcomes

  1. The quality of life after using mouthguard with/without desensitizing toothpaste

    Time frame: 8 weeks

    • The quality of life will be collected by interview at 8 weeks using oral impacts on daily performance (OIDP) questionnaire
    • The score range from 0 (no negative effect on quality of life) to 100 (worst negative effect on quality of life )
    • The mean score will be analyzed.

Sponsors and collaborators

Lead sponsor

Khon Kaen University

Other

Registry information

Official study title

The Effects of Mouthguard With Desensitizing Toothpaste in Reducing Dental Hypersensitivity in Swimmers : A Randomized Clinical Trial

Important dates

Study start
2018
Primary completion
2018
Study completion
2019
First posted
May 4, 2018
Registry last updated
Aug 6, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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