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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03515902
Other study ID # KKUHE612062
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 18, 2018
Est. completion date May 31, 2019

Study information

Verified date January 2019
Source Khon Kaen University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 46
Est. completion date May 31, 2019
Est. primary completion date December 31, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 13 Years to 25 Years
Eligibility 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

Study Design


Intervention

Device:
mouthguard
mouthguard
mouthguard with desensitizing toothpaste
mouthguard with desensitizing toothpaste containing 8% arginine with calcium carbonate

Locations

Country Name City State
Thailand Faculty of Dentistry , Khon Kaen University Khon Kaen

Sponsors (1)

Lead Sponsor Collaborator
Khon Kaen University

Country where clinical trial is conducted

Thailand, 

Outcome

Type Measure Description Time frame Safety issue
Other 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.
8 weeks
Primary 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.
baseline,2,4 and 8 weeks
Secondary 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.
2,4 and 8 weeks
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