The Effects of Mouthguard and Desensitizing Toothpaste in Reducing Dental Hypersensitivity
Primary Purpose
Dentine Hypersensitivity, Tooth Erosion
Status
Completed
Phase
Not Applicable
Locations
Thailand
Study Type
Interventional
Intervention
mouthguard
mouthguard with desensitizing toothpaste
Sponsored by
About this trial
This is an interventional treatment trial for Dentine Hypersensitivity focused on measuring Dentine Hypersensitivity, Toothpaste, Tooth erosion
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
Sites / Locations
- Faculty of Dentistry , Khon Kaen University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
mouthguard
mouthguard with desensitizing toothpaste
Arm Description
Mouthguard arm is application of mouthguard while swimming
Mouthguard with desensitizing toothpaste arm is application of mouthguard with desensitizing toothpaste containing 8% arginine and calcium carbonate while swimming
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03515902
Brief Title
The Effects of Mouthguard and Desensitizing Toothpaste in Reducing Dental Hypersensitivity
Official Title
The Effects of Mouthguard With Desensitizing Toothpaste in Reducing Dental Hypersensitivity in Swimmers : A Randomized Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
June 18, 2018 (Actual)
Primary Completion Date
December 31, 2018 (Actual)
Study Completion Date
May 31, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Khon Kaen University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dentine Hypersensitivity, Tooth Erosion
Keywords
Dentine Hypersensitivity, Toothpaste, Tooth erosion
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
46 (Actual)
8. Arms, Groups, and Interventions
Arm Title
mouthguard
Arm Type
Experimental
Arm Description
Mouthguard arm is application of mouthguard while swimming
Arm Title
mouthguard with desensitizing toothpaste
Arm Type
Experimental
Arm Description
Mouthguard with desensitizing toothpaste arm is application of mouthguard with desensitizing toothpaste containing 8% arginine and calcium carbonate while swimming
Intervention Type
Device
Intervention Name(s)
mouthguard
Intervention Description
mouthguard
Intervention Type
Device
Intervention Name(s)
mouthguard with desensitizing toothpaste
Intervention Description
mouthguard with desensitizing toothpaste containing 8% arginine with calcium carbonate
Primary Outcome Measure Information:
Title
Tooth hypersensitivity changes after using mouthguard with/without desensitizing toothpaste
Description
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 Outcome Measure Information:
Title
The attitude and satisfaction of using mouthguard with/without desensitizing toothpaste
Description
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 Pre-specified Outcome Measures:
Title
The quality of life after using mouthguard with/without desensitizing toothpaste
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kemporn Kitsahawong, DDS,MSc,PhD
Organizational Affiliation
Faculty of Dentistry, Khon Kaen University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faculty of Dentistry , Khon Kaen University
City
Khon Kaen
ZIP/Postal Code
40002
Country
Thailand
12. IPD Sharing Statement
Plan to Share IPD
No
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The Effects of Mouthguard and Desensitizing Toothpaste in Reducing Dental Hypersensitivity
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