The Effects of Mouthguard and Desensitizing Toothpaste in Reducing Dental Hypersensitivity

Dentine Hypersensitivity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03515902
• Other study ID #: KKUHE612062
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Dentin Sensitivity
• Dentine Hypersensitivity
• Hypersensitivity
• Tooth Erosion

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