The Effects of Mouthguard and Desensitizing Toothpaste in Reducing Dental Hypersensitivity

NCT03515902 | Completed

• 1 other identifier: KKUHE612062
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

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.

Conditions

Dentine Hypersensitivity; Tooth Erosion

Keywords

Dentine Hypersensitivity; Toothpaste; Tooth erosion

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• The attitude and satisfaction of using mouthguard with/without desensitizing toothpaste

  2,4 and 8 weeks

Other Outcomes (1)

• The quality of life after using mouthguard with/without desensitizing toothpaste

  8 weeks

Study Arms (2)

mouthguard

EXPERIMENTAL

Mouthguard arm is application of mouthguard while swimming

Device: mouthguard

mouthguard with desensitizing toothpaste

EXPERIMENTAL

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

Interventions

mouthguard DEVICE

mouthguard

mouthguard

mouthguard with desensitizing toothpaste DEVICE

mouthguard with desensitizing toothpaste containing 8% arginine with calcium carbonate

mouthguard with desensitizing toothpaste

Eligibility Criteria

• Age: 13 Years - 25 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• History of allergic to toothpaste
• Having any tooth which will affect to the tightness of mouthguard
• Having fixed orthodontic appliance

Sponsors & Collaborators

• Khon Kaen University: lead

Study Sites (1)

Faculty of Dentistry , Khon Kaen University

Khon Kaen, 40002, Thailand

Location

MeSH Terms

Conditions

Dentin Sensitivity; Tooth Erosion

Interventions

Mouth Protectors

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases; Tooth Demineralization; Tooth Wear

Intervention Hierarchy (Ancestors)

Preventive Dentistry; Dentistry; Protective Devices; Equipment and Supplies; Personal Protective Equipment; Manufactured Materials; Technology, Industry, and Agriculture

Study Officials

• Kemporn Kitsahawong, DDS,MSc,PhD

  Faculty of Dentistry, Khon Kaen University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: April 23, 2018
• First Posted: May 4, 2018
• Study Start: June 18, 2018
• Primary Completion: December 31, 2018
• Study Completion: May 31, 2019
• Last Updated: August 6, 2019

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share

Locations

TH (1)