Dentin SensitivityNCT04590040
Trial of Nano-hydroxyapatite-Containing Toothpastes for Relief of Dentin Hypersensitivity
A study testing 15% nano-HAP toothpaste and 5% KNO3 toothpaste in people with Dentin Sensitivity, run by The University of Texas Health Science Center at San Antonio at 1 site in United States.
Trial summary
Subjects will be enrolled into 3 balanced groups each using a different strength toothpaste. Dental hypersensitivity (DHS) will be assessed at study start, midway and study end. Read more about this study
- Who is it for?
- Ages 20 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Dentin Sensitivity
- What is being tested?
- 15% nano-HAP toothpaste and 5% KNO3 toothpaste
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 192 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Jul 2020to 1 Mar 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 20 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Males or females between the age of 20 and 80 years, of any socio-economic status
- Diagnosed as having DHS, i.e. having at least one sensitive tooth with demonstrated cervical erosion/abrasion or gingival recession
- Showing a sensitivity response to both tactile and cold air stimulus delivered by a Yeaple probe and a one-second blast of cold air respectively
- Patients must be reliable, cooperative and of adequate intelligence to read and understand the rating scales and other study instructions
- Patients must be able to read, comprehend, and sign the informed consent form
- The teeth and sites to be tested should be on the buccal/labial surfaces of incisors, canines, premolars or molars where the affected sites are accessible
- Teeth selected for testing should have a plaque index of ≤ 2
Who cannot join
- The sensitive tooth is associated with concomitant oral pain due to any other condition such as soft-tissue lesions, tooth-ache ascribable to dental caries, tooth fracture, or cracked tooth syndrome, or pain due to other surgical procedures or injuries.
- The sensitive tooth is associated with a periodontal abscess as diagnosed from an X-ray or clinical examination of the tooth
- The sensitive tooth is associated with mobility >1
- The sensitive tooth is associated with gum pain from gingivitis, occlusal trauma, thermal or chemical burns
- Patients having pain from periodontal-related causes but not DHS
- Previous professional desensitizing treatment
Show all 18Show fewer
- Patients using medication which could interfere with the perception of pain
- Medical histories marked by chronic use of anti-inflammatory agents, daily analgesics, anticonvulsants, antihistamines, antidepressants, sedatives and/or other psychotropic drugs
- Pregnancy or breastfeeding
- Allergies and idiosyncratic responses to toothpaste ingredients
- Eating disorders or conditions associated with vomiting
- Systemic conditions that are etiologic or predisposing to DHS
- Excessive dietary or environmental exposure to acids
- The sensitive tooth was restored in the preceding three months
- The sensitive tooth is an abutment tooth for fixed or removable prostheses
- The sensitive tooth has extensive restoration or restorations extending into the test area
- Patients below 20 years or above 80 years of age
- Smokers
Trial locations and contacts
1 site in 1 country.
United States1 site
School of Dentistry, University of Texas Health Science Center
San Antonio, Texas, 78229
About this study
Official title: Randomized Non-inferiority Trial of Nano-hydroxyapatite-Containing Toothpastes for Relief of Dentin Hypersensitivity
Subjects will be enrolled into 3 balanced groups each using a different strength toothpaste. Dental hypersensitivity (DHS) will be assessed at study start, midway and study end.
Read the detailed description
This study is a double-blind, randomized, placebo-and positive-controlled, stratified parallel group clinical trial. The three groups will be randomly assigned to use one of three test toothpastes having an identical base formulation but containing respectively either 0% nano-hydroxyapatite (HAP) (placebo), 15% nano-HAP or 5% KNO3 (positive control). All dental examinations for data collection will be conducted by the same Clinical Examiner.
- Conditions
- Dentin Sensitivity
- Being tested
- Placebo, 15% nano-HAP toothpaste, 5% KNO3 toothpaste
- Medical subject headings
- Dentin Sensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboOther
Also called Placebo toothpaste
0% nano-HAP toothpaste
15% nano-HAP toothpasteDevice
Also called 15 % nano-Hydroxyapatite toothpaste
Toothpaste with identical base formulation as the placebo containing 15% nano-HAP
5% KNO3 toothpasteDevice
Also called 5% Potassium Nitrate Toothpaste
Toothpaste with identical base formulation as the placebo containing 5% KNO3
| Study group | Role | What they receive |
|---|---|---|
| Toothpaste 1 | Active comparator | Toothpaste 3 containing 5% potassium nitrate (KNO3) will be used by subjects to brush their teeth twice daily for 3 minutes in the morning and before bed each night using a 1 inch strip of toothpaste on a soft-bristled toothbrush. Receives: Device: 5% KNO3 toothpaste |
| Toothpaste 2 | Active comparator | Toothpaste 2 containing 15% nano-HAP will be used by subjects to brush their teeth twice daily for 3 minutes in the morning and before bed each night using a 1 inch strip of toothpaste on a soft-bristled toothbrush. Receives: Device: 15% nano-HAP toothpaste |
| Toothpaste 3 | Placebo comparator | Toothpaste 1 containing 0% nano-hydroxyapatite (HAP) will be used by subjects to brush their teeth twice daily for 3 minutes in the morning and before bed each night using a 1 inch strip of toothpaste on a soft-bristled toothbrush. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of Cold Air Stimulus
The primary efficacy outcome will be the decrease in cold air stimulus sensitivity (VAS score) from baseline to 8 weeks. Assessment of change in cold air sensitivity will be conducted using air delivered from a standard dental unit air syringe at room temperature (~70°F±3°F)(~21°C±2°C) and a pressure of 60psi (± 5psi). Assessment of sensitivity will be carried out using Visual Analog Scale (VAS). Tooth sensitivity was measured using a Cold Air Stimulus. When being assessed, participants rated their perception of the pain/discomfort experienced when cold air was directed at the exposed root of each tooth by marking a single vertical line on a Visual Analogue Scale (VAS) scale from 0 to 100 mm, where 0 = No Pain/Discomfort and 100 = Intense Pain/Discomfort.
Measured: Week 0 (baseline), 4 weeks and 8 weeks
Secondary outcomes (1)
Measurement of Tactile Stimulus
The secondary efficacy outcome will be the increase in tactile stimulus force from baseline to 8 weeks. Assessment of Change in tactile sensitivity will be assessed using the Yeaple Electronic Force Sensing Probe.The explorer tip will be applied perpendicular to the tooth surface and a pressure load applied starting at 10 g and increasing to 80g. The load at which the subject says "yes" will be recorded. (Baseline screening will begin at 30g).
Measured: Week 0 (baseline), 4 weeks 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 posted19 Oct 2020
- Study start28 Jul 2020
- Primary completion5 Feb 2022
- Study completion1 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Dentin SensitivityStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center at San AntonioThe sponsor's other registered studies.
- 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 192 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Sangi Co., Ltd.
- Responsible party
- Principal investigator, Bennett Amaechi, The University of Texas Health Science Center at San Antonio
- Investigators
- Bennett T Amaechi, BDS, MS, PhD, Principal investigator, University of Texas Health at San Antonio
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04590040
- Sponsor's protocol ID
- HSC20190535H
- Status last verified
- Jul 2023
- First submitted
- 3 Oct 2020
- Last updated
- 16 Aug 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Individual participant data will be shared as de-identified data as summary results reported in ClinicalTrials.gov and in journal publication.
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Non-inferiority Trial of Nano-hydroxyapatite-Containing Toothpastes for Relief of Dentin Hypersensitivity
- ClinicalTrials.gov ID
- NCT04590040
- Acronym / sponsor ID
- HSC20190535H
- Conditions
- Dentin Sensitivity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 192 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center at San AntonioUniversity, hospital or other
- Collaborators
- Sangi Co., Ltd.
- Study start
- 28 Jul 2020 (actual)
- Primary completion
- 5 Feb 2022 (actual)
- Study completion
- 1 Mar 2023 (actual)
- First posted
- 19 Oct 2020 (actual)
- Results
- Posted 16 Aug 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Subjects will be enrolled into 3 balanced groups each using a different strength toothpaste. Dental hypersensitivity (DHS) will be assessed at study start, midway and study end.
Detailed description
This study is a double-blind, randomized, placebo-and positive-controlled, stratified parallel group clinical trial. The three groups will be randomly assigned to use one of three test toothpastes having an identical base formulation but containing respectively either 0% nano-hydroxyapatite (HAP) (placebo), 15% nano-HAP or 5% KNO3 (positive control). All dental examinations for data collection will be conducted by the same Clinical Examiner.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Toothpaste 1 | Active comparator | Device: 5% KNO3 toothpasteToothpaste 3 containing 5% potassium nitrate (KNO3) will be used by subjects to brush their teeth twice daily for 3 minutes in the morning and before bed each night using a 1 inch strip of toothpaste on a soft-bristled toothbrush. |
| Toothpaste 2 | Active comparator | Device: 15% nano-HAP toothpasteToothpaste 2 containing 15% nano-HAP will be used by subjects to brush their teeth twice daily for 3 minutes in the morning and before bed each night using a 1 inch strip of toothpaste on a soft-bristled toothbrush. |
| Toothpaste 3 | Placebo comparator | Other: PlaceboToothpaste 1 containing 0% nano-hydroxyapatite (HAP) will be used by subjects to brush their teeth twice daily for 3 minutes in the morning and before bed each night using a 1 inch strip of toothpaste on a soft-bristled toothbrush. |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Males or females between the age of 20 and 80 years, of any socio-economic status
- Diagnosed as having DHS, i.e. having at least one sensitive tooth with demonstrated cervical erosion/abrasion or gingival recession
- Showing a sensitivity response to both tactile and cold air stimulus delivered by a Yeaple probe and a one-second blast of cold air respectively
- Patients must be reliable, cooperative and of adequate intelligence to read and understand the rating scales and other study instructions
- Patients must be able to read, comprehend, and sign the informed consent form
Key exclusion criteria (18 listed)
- The sensitive tooth is associated with concomitant oral pain due to any other condition such as soft-tissue lesions, tooth-ache ascribable to dental caries, tooth fracture, or cracked tooth syndrome, or pain due to other surgical procedures or injuries.
- The sensitive tooth is associated with a periodontal abscess as diagnosed from an X-ray or clinical examination of the tooth
- The sensitive tooth is associated with mobility >1
- The sensitive tooth is associated with gum pain from gingivitis, occlusal trauma, thermal or chemical burns
- Patients having pain from periodontal-related causes but not DHS
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 |
|---|---|---|
| PlaceboAlso: Placebo toothpaste0% nano-HAP toothpaste | Other | Toothpaste 3 |
| 15% nano-HAP toothpasteAlso: 15 % nano-Hydroxyapatite toothpasteToothpaste with identical base formulation as the placebo containing 15% nano-HAP | Device | Toothpaste 2 |
| 5% KNO3 toothpasteAlso: 5% Potassium Nitrate ToothpasteToothpaste with identical base formulation as the placebo containing 5% KNO3 | Device | Toothpaste 1 |
Primary outcome
Measurement of Cold Air Stimulus
Time frame: Week 0 (baseline), 4 weeks and 8 weeks
The primary efficacy outcome will be the decrease in cold air stimulus sensitivity (VAS score) from baseline to 8 weeks. Assessment of change in cold air sensitivity will be conducted using air delivered from a standard dental unit air syringe at room temperature (~70°F±3°F)(~21°C±2°C) and a pressure of 60psi (± 5psi). Assessment of sensitivity will be carried out using Visual Analog Scale (VAS). Tooth sensitivity was measured using a Cold Air Stimulus. When being assessed, participants rated their perception of the pain/discomfort experienced when cold air was directed at the exposed root of each tooth by marking a single vertical line on a Visual Analogue Scale (VAS) scale from 0 to 100 mm, where 0 = No Pain/Discomfort and 100 = Intense Pain/Discomfort.
1 secondary outcome
Measurement of Tactile Stimulus
Time frame: Week 0 (baseline), 4 weeks and 8 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. Individual participant data will be shared as de-identified data as summary results reported in ClinicalTrials.gov and in journal publication.
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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.
Bennett T Amaechi, BDS, MS, PhD principal investigator
University of Texas Health at San Antonio
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 15% nano-HAP toothpaste and 5% KNO3 toothpaste in people with Dentin Sensitivity, run by The University of Texas Health Science Center at San Antonio at 1 site in United States.
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 7 inclusion and 18 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 16 Aug 2023. 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 United States. 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. Some participants in this study may receive a placebo. 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?
Yes. Results are posted in the registry (first posted 16 Aug 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Measurement of Cold Air Stimulus (time frame: Week 0 (baseline), 4 weeks 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 16 Aug 2023.