ClinicalTrials.gg
CompletedNCT03515902Updated Aug 6, 2019

The Effects of Mouthguard and Desensitizing Toothpaste in Reducing Dental Hypersensitivity

An interventional study of mouthguard and mouthguard with desensitizing toothpaste in Dentine Hypersensitivity and Tooth Erosion, sponsored by Khon Kaen University. Completed at 1 site in Thailand. Open to participants aged 13 Years to 25 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-08-06.

Sponsored by Khon Kaen University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
46
Allocation
Randomized
Ages
13 Years to 25 Years
Sex
All
01

Study summary

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.

Read the detailed description

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.

02

Conditions studied

  • Dentine Hypersensitivity
  • Tooth Erosion

Keywords

  • Dentine Hypersensitivity
  • Toothpaste
  • Tooth erosion
03

In context

Dentin Sensitivity

288 studies on the registry are indexed under Dentin Sensitivity; 46 are open to participants now.

This study's enrollment of 46 is below the median of 60 across 279 interventional studies indexed under Dentin Sensitivity.

Browse Dentin Sensitivity studies →

Lead sponsor

Khon Kaen University is the lead sponsor of 161 studies on the registry; 24 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
13 Years to 25 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • History of allergic to toothpaste
  • Having any tooth which will affect to the tightness of mouthguard
  • Having fixed orthodontic appliance
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Investigator)
Enrollment
46 participants (actual)

Study arms

  • Experimental
    mouthguard

    Mouthguard arm is application of mouthguard while swimming

    Device: mouthguard

  • Experimental
    mouthguard with desensitizing toothpaste

    Mouthguard with desensitizing toothpaste arm is application of mouthguard with desensitizing toothpaste containing 8% arginine and calcium carbonate while swimming

    Device: mouthguard with desensitizing toothpaste

Interventions

  • Devicemouthguard

    mouthguard

  • Devicemouthguard with desensitizing toothpaste

    mouthguard with desensitizing toothpaste containing 8% arginine with calcium carbonate

06

What researchers measure

Primary outcomes

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

    * 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. 2. 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.

    Time frame: baseline,2,4 and 8 weeks

Secondary outcomes

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

    * 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.

    Time frame: 2,4 and 8 weeks

Other outcomes

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

    * 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.

    Time frame: 8 weeks

07

Study locations

1 site
  • Faculty of Dentistry , Khon Kaen University
    Khon Kaen, 40002, Thailand
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 6, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03515902
Responsible party
Kemporn Kitsahawong (Associate Professor, Khon Kaen University) — Principal investigator
First posted
May 4, 2018
Start date
Jun 18, 2018
Primary completion
Dec 31, 2018
Completion
May 31, 2019
Last update
Aug 6, 2019

Study contacts

Kemporn Kitsahawong, DDS,MSc,PhD
principal investigator · Faculty of Dentistry, Khon Kaen University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2019. You cannot join it, but the record below documents what was studied.

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