Dentine HypersensitivityNCT03515902
The Effects of Mouthguard and Desensitizing Toothpaste in Reducing Dental Hypersensitivity
A study testing mouthguard and mouthguard with desensitizing toothpaste in people with Dentine Hypersensitivity and Tooth Erosion, run by Khon Kaen University at 1 site in Thailand.
Trial 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. Read more about this study
- Who is it for?
- Ages 13 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Dentine Hypersensitivity, Tooth Erosion
- What is being tested?
- mouthguard and mouthguard with desensitizing toothpaste
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteThailand
- Study dates
- 18 Jun 2018to 31 May 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 25 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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
Who cannot join
- History of allergic to toothpaste
- Having any tooth which will affect to the tightness of mouthguard
- Having fixed orthodontic appliance
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Dentine Hypersensitivity, Tooth Erosion
- Being tested
- mouthguard, mouthguard with desensitizing toothpaste
- Keywords
- Dentine Hypersensitivity, Toothpaste, Tooth erosion
- Medical subject headings
- Dentin Sensitivity, Tooth Erosion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mouthguardDevice
mouthguard
mouthguard with desensitizing toothpasteDevice
mouthguard with desensitizing toothpaste containing 8% arginine with calcium carbonate
| Study group | Role | What they receive |
|---|---|---|
| mouthguard | Experimental | Mouthguard arm is application of mouthguard while swimming Receives: 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 Receives: Device: mouthguard with desensitizing toothpaste |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
- 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.
Measured: baseline,2,4 and 8 weeks
Secondary outcomes (1)
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.
Measured: 2,4 and 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2018
- Study start18 Jun 2018
- Primary completion31 Dec 2018
- Study completion31 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dentine HypersensitivityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Khon Kaen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kemporn Kitsahawong, Khon Kaen University
- Investigators
- Kemporn Kitsahawong, DDS,MSc,PhD, Principal investigator, Faculty of Dentistry, Khon Kaen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03515902
- Sponsor's protocol ID
- KKUHE612062
- Status last verified
- Jan 2019
- First submitted
- 23 Apr 2018
- Last updated
- 6 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Mouthguard With Desensitizing Toothpaste in Reducing Dental Hypersensitivity in Swimmers : A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03515902
- Acronym / sponsor ID
- KKUHE612062
- Conditions
- Dentine Hypersensitivity, Tooth Erosion
- Keywords
- Dentine Hypersensitivity, Toothpaste, Tooth erosion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Khon Kaen UniversityUniversity, hospital or other
- Study start
- 18 Jun 2018 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 31 May 2019 (actual)
- First posted
- 4 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| mouthguard | Experimental | Device: mouthguardMouthguard arm is application of mouthguard while swimming |
| mouthguard with desensitizing toothpaste | Experimental | Device: mouthguard with desensitizing toothpasteMouthguard with desensitizing toothpaste arm is application of mouthguard with desensitizing toothpaste containing 8% arginine and calcium carbonate while swimming |
Who may qualify
- Ages
- 13 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- History of allergic to toothpaste
- Having any tooth which will affect to the tightness of mouthguard
- Having fixed orthodontic appliance
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| mouthguardmouthguard | Device | mouthguard |
| mouthguard with desensitizing toothpastemouthguard with desensitizing toothpaste containing 8% arginine with calcium carbonate | Device | mouthguard with desensitizing toothpaste |
Primary outcome
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.
1 secondary outcome
The attitude and satisfaction of using mouthguard with/without desensitizing toothpaste
Time frame: 2,4 and 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kemporn Kitsahawong, DDS,MSc,PhD principal investigator
Faculty of Dentistry, Khon Kaen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing mouthguard and mouthguard with desensitizing toothpaste in people with Dentine Hypersensitivity and Tooth Erosion, run by Khon Kaen University at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tooth hypersensitivity changes after using mouthguard with/without desensitizing toothpaste (time frame: baseline,2,4 and 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2019.