The Effects of Mouthguard and Desensitizing Toothpaste in Reducing Dental Hypersensitivity

Sponsor
Khon Kaen University (Other)
Overall Status
Completed
CT.gov ID
NCT03515902
Collaborator
(none)
46
1
2
11.4
4

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Device: mouthguard
  • Device: mouthguard with desensitizing toothpaste
N/A

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 Design

Study Type:
Interventional
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 :
Jun 18, 2018
Actual Primary Completion Date :
Dec 31, 2018
Actual Study Completion Date :
May 31, 2019

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Tooth hypersensitivity changes after using mouthguard with/without desensitizing toothpaste [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 [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 [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
13 Years to 25 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Faculty of Dentistry , Khon Kaen University Khon Kaen Thailand 40002

Sponsors and Collaborators

  • Khon Kaen University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Kemporn Kitsahawong, Associate Professor, Khon Kaen University
ClinicalTrials.gov Identifier:
NCT03515902
Other Study ID Numbers:
  • KKUHE612062
First Posted:
May 4, 2018
Last Update Posted:
Aug 6, 2019
Last Verified:
Jan 1, 2019
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Kemporn Kitsahawong, Associate Professor, Khon Kaen University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 6, 2019