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The Effects of Mouthguard and Desensitizing Toothpaste in Reducing Dental Hypersensitivity

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03515902
Recruitment Status : Completed
First Posted : May 4, 2018
Last Update Posted : August 6, 2019
Sponsor:
Information provided by (Responsible Party):
Kemporn Kitsahawong, Khon Kaen University

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.

Condition or disease Intervention/treatment Phase
Dentine Hypersensitivity Tooth Erosion Device: mouthguard Device: mouthguard with desensitizing toothpaste Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 46 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: The Effects of Mouthguard With Desensitizing Toothpaste in Reducing Dental Hypersensitivity in Swimmers : A Randomized Clinical Trial
Actual Study Start Date : June 18, 2018
Actual Primary Completion Date : December 31, 2018
Actual Study Completion Date : May 31, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Allergy

Arm Intervention/treatment
Experimental: mouthguard
Mouthguard arm is application of mouthguard while swimming
Device: mouthguard
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
mouthguard with desensitizing toothpaste containing 8% arginine with calcium carbonate




Primary Outcome Measures :
  1. Tooth hypersensitivity changes after using mouthguard with/without desensitizing toothpaste [ Time Frame: baseline,2,4 and 8 weeks ]
    • 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 :
  1. The attitude and satisfaction of using mouthguard with/without desensitizing toothpaste [ Time Frame: 2,4 and 8 weeks ]
    • 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.


Other Outcome Measures:
  1. The quality of life after using mouthguard with/without desensitizing toothpaste [ Time Frame: 8 weeks ]
    • 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   13 Years to 25 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03515902


Locations
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Thailand
Faculty of Dentistry , Khon Kaen University
Khon Kaen, Thailand, 40002
Sponsors and Collaborators
Khon Kaen University
Investigators
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Principal Investigator: Kemporn Kitsahawong, DDS,MSc,PhD Faculty of Dentistry, Khon Kaen University

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Responsible Party: Kemporn Kitsahawong, Associate Professor, Khon Kaen University
ClinicalTrials.gov Identifier: NCT03515902    
Other Study ID Numbers: KKUHE612062
First Posted: May 4, 2018    Key Record Dates
Last Update Posted: August 6, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Kemporn Kitsahawong, Khon Kaen University:
Dentine Hypersensitivity
Toothpaste
Tooth erosion
Additional relevant MeSH terms:
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Dentin Sensitivity
Tooth Erosion
Hypersensitivity
Immune System Diseases
Tooth Diseases
Stomatognathic Diseases
Tooth Wear
Calcium Carbonate
Antacids
Molecular Mechanisms of Pharmacological Action
Gastrointestinal Agents