The Effects of Mouthguard and Desensitizing Toothpaste in Reducing Dental Hypersensitivity

Study Overview
=================
Brief 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.

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.

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

Conditions
-----------------
Dentine Hypersensitivity, Tooth Erosion

Intervention / Treatment
-----------------
* Device: mouthguard
* Device: mouthguard with desensitizing toothpaste


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 13 Years
Maximum Age: 25 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: mouthguard<br>Mouthguard arm is application of mouthguard while swimming | Device: mouthguard<br>* mouthguard<br>|
| Experimental: mouthguard with desensitizing toothpaste<br>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<br>* mouthguard with desensitizing toothpaste containing 8% arginine with calcium carbonate<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Dentine Hypersensitivity, Toothpaste, Tooth erosion