The Effects of Mouthguard and Desensitizing Toothpaste in Reducing Dental Hypersensitivity

August 5, 2019 updated by: Kemporn Kitsahawong, Khon Kaen University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

46

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Thailand
      • Khon Kaen, Thailand, 40002
        • Faculty of Dentistry , Khon Kaen University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

9 years to 21 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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
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.
2,4 and 8 weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Khon Kaen University

Investigators

  • Principal Investigator: Kemporn Kitsahawong, DDS,MSc,PhD, Faculty of Dentistry, Khon Kaen University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 18, 2018

Primary Completion (Actual)

December 31, 2018

Study Completion (Actual)

May 31, 2019

Study Registration Dates

First Submitted

April 23, 2018

First Submitted That Met QC Criteria

April 23, 2018

First Posted (Actual)

May 4, 2018

Study Record Updates

Last Update Posted (Actual)

August 6, 2019

Last Update Submitted That Met QC Criteria

August 5, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KKUHE612062

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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