Dentin SensitivityPhase 2NCT02918617
Clinical Efficacy in Relieving Dentin Hypersensitivity of Nanohydroxyapatite-Containing Toothpastes and Cream
A Phase 2 study testing Test toothpaste with nano-HAP (high concentration), Test toothpaste with nano-HAP (low concentration) and Test toothpaste with nano-HAP and (Potassium Nitrate) KNO3 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
This study will investigate the effectiveness of nanohydroxyapatite (nano-HAP)-containing toothpastes and cream to relieve dentin hypersensitivity, comparing it with those of a commercial desensitizing dentifrice containing calcium sodium phosphosilicate (Novamin® technology) and a standard fluoride dentifrice… Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Dentin Sensitivity
- What is being tested?
- Test toothpaste with nano-HAP (high concentration), Test toothpaste with nano-HAP (low concentration) and Test toothpaste with nano-HAP and (Potassium Nitrate) KNO3
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 203 participants
- Where
- 1 siteUnited States
- Study dates
- May 2015to Sep 2016
- Phase
- Phase 2
- 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 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Must be between the ages of 18 and 80, inclusive
- Must be in good general health based on medical history and oral soft and hard tissue examinations
- Must be willing and able to provide informed consent
- Must be able to read and comprehend study materials
- Must have access to a phone for regular study contact
- Must be willing to use the assigned products according to instructions, and be availability for appointments.
Show all 10Show fewer
- Must have been diagnosed of having dentin hypersensitivity by a dentist, with at least one sensitive tooth with demonstrated cervical erosion/abrasion or gingival recession
- As a final entrance criteria, the sensitive tooth must respond to:
- air sensitivity, with Schiff score >1, assessed by use of a one-second blast of air.
- thermal sensitivity, assessed with frozen cotton pellet, with a pain rating of at least moderate pain on the Dental Pain Scale (DPS) and a score between 30 and 80 mm on a 100 mm scale on the Visual Analog Scale (VAS).
Who cannot join
- Subjects who answer YES to any of the following questions will not be enrolled into the study:
- Any history of significant adverse effects following use of oral hygiene products such as toothpastes and mouthwashes?
- Does the subject have any physical limitations or restrictions that might preclude use of normal oral hygiene procedures (i.e., toothbrushing, mouthrinsing, etc.)?
- The sensitive tooth is associated with concomitant oral pain due to any other condition such as: soft-tissue lesions or toothache from other dental conditions like dental caries, etc?
- Has the subject ever reported allergy to drugs or chemicals used in the trial?
- The sensitive tooth is associated with a periodontal abscess as diagnosed from an X-ray or clinical examination of the tooth?
Show all 24Show fewer
- Will the subject receive dental treatment which may affect their participation (i.e. oral prophylaxis)?
- The sensitive tooth is associated with mobility > 1?
- Did the subject participate in a dental clinical trial involving oral care products within the past 30 days?
- Is the subject pregnant, nursing or planning to become pregnant during the course of the study (self-reported)?
- Does the subject have other severe, acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with trial participation or may interfere with the interpretation of trial result and, in the judgment of the investigator, would make the subject inappropriate for entry into this trial?
- Does the subject have significant oral soft tissue pathology, based on the dentist's visual examination and at the discretion of the investigator?
- 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 dentin hypersensitivity?
- Previous professional desensitizing treatment?
- Subject use of over-the-counter desensitizing products within the previous 3 months?
- Subjects using medication which could interfere with the perception of pain?
- Eating disorders or conditions associated with vomiting?
- Systemic conditions that are etiologic or predisposing to dentinal hypersensitivity?
- Excessive dietary or environmental exposure to acids?
- The sensitive tooth was restored in the preceding 3 months?
- The sensitive tooth is an abutment tooth for fixed or removable prostheses?
- The sensitive tooth has extensive restorations or restoration extending into the test area?
- Patients below 18 years or above 80 years of age?
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
This study will investigate the effectiveness of nanohydroxyapatite (nano-HAP)-containing toothpastes and cream to relieve dentin hypersensitivity, comparing it with those of a commercial desensitizing dentifrice containing calcium sodium phosphosilicate (Novamin® technology) and a standard fluoride dentifrice containing 1,500 ppm fluoride as sodium monofluorophosphate (MFP).
Read the detailed description
This is a double-blind, randomized, controlled, parallel group, outpatient clinical trial, involving a total of 270 patients diagnosed with dentin hypersensitivity, who will be randomly assigned to nine treatment groups of 30 patients each. Males or females of age 18 to 80 years will be enrolled. The nine groups will be randomly assigned to use one of the nine test products: (1) toothpaste containing nano-HAP (high concentration); (2) toothpaste containing nano-HAP (low concentration); (3) toothpaste containing nano-HAP and potassium nitrate (KNO3); (4) toothpaste containing NovaMin; (5) standard fluoride toothpaste with 1500 ppm MFP; (6) toothpaste containing nano-HAP (medium concentration); (7) placebo toothpaste; (8) cream containing nano-HAP; (9) placebo cream. Subjects will be instructed to use the study toothpaste as their sole oral hygiene product for the 8 weeks treatment duration while the cream will be applied with a retainer tray for 5 minutes before bed at night. For those using toothpastes, subjects will be instructed to brush their teeth twice daily for 2 minutes, morning and last thing before bed, applying on each occasion a one-inch strip of their assigned toothpaste on a wetted commercially available soft-bristled toothbrush. Dentin hypersensitivity examination, which will include air blast sensitivity and cold thermal sensitivity combined with visual analog scale and Dental Pain Scale, will be conducted at baseline, 2, 4, 6, and 8 weeks. Subjects will be screened for adverse effects on every visit, and all observed adverse events will be recorded when they occur.
- Conditions
- Dentin Sensitivity
- Being tested
- Control toothpaste containing Novamin® technology, Control toothpaste containing 1500 ppm fluoride as MFP, Test toothpaste with nano-HAP (high concentration), Test toothpaste with nano-HAP (low concentration), Test toothpaste with nano-HAP and (Potassium Nitrate) KNO3
- Keywords
- dentin hypersensitivity, nanohydroxyapatite, calcium sodium phosphosilicate, toothpaste, tooth cream
- Medical subject headings
- Dentin Sensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Control toothpaste containing Novamin® technologyDrug
Control toothpaste containing 1500 ppm fluoride as MFPDrug
Test toothpaste with nano-HAP (high concentration)Drug
Test toothpaste with nano-HAP (low concentration)Drug
Test toothpaste with nano-HAP and (Potassium Nitrate) KNO3Drug
Control toothpaste without nano-HAPDrug
Test toothpaste with nano-HAP (medium concentration)Drug
Test cream with nano-HAP (higher concentration)Drug
Control cream without nano-HAPDrug
| Study group | Role | What they receive |
|---|---|---|
| Control toothpaste containing Novamin® technology | Active comparator | Participants will be instructed to apply a full ribbon of toothpaste to a damp toothbrush. Participants will then brush for 2 minutes followed by rinsing with 15 mL of water. Participants will be instructed not to eat or drink for 30 minutes following brushing. Brushing will be performed twice a day (morning and evening). Receives: Drug: Control toothpaste containing Novamin® technology |
| Control toothpaste containing 1500 ppm fluoride as MFP | Placebo comparator | Participants will be instructed to apply a full ribbon of toothpaste to a damp toothbrush. Participants will then brush for 2 minutes followed by rinsing with 15 mL of water. Participants will be instructed not to eat or drink for 30 minutes following brushing. Brushing will be performed twice a day (morning and evening). Receives: Drug: Control toothpaste containing 1500 ppm fluoride as MFP |
| Test toothpaste with nano-HAP (high concentration) | Experimental | Participants will be instructed to apply a full ribbon of toothpaste to a damp toothbrush. Participants will then brush for 2 minutes followed by rinsing with 15 mL of water. Participants will be instructed not to eat or drink for 30 minutes following brushing. Brushing will be performed twice a day (morning and evening). Receives: Drug: Test toothpaste with nano-HAP (high concentration) |
| Test toothpaste with nano-HAP (low concentration) | Experimental | Participants will be instructed to apply a full ribbon of toothpaste to a damp toothbrush. Participants will then brush for 2 minutes followed by rinsing with 15 mL of water. Participants will be instructed not to eat or drink for 30 minutes following brushing. Brushing will be performed twice a day (morning and evening). Receives: Drug: Test toothpaste with nano-HAP (low concentration) |
| Test toothpaste with nano-HAP and potassium nitrate (KNO3) | Experimental | Participants will be instructed to apply a full ribbon of toothpaste to a damp toothbrush. Participants will then brush for 2 minutes followed by rinsing with 15 mL of water. Participants will be instructed not to eat or drink for 30 minutes following brushing. Brushing will be performed twice a day (morning and evening). Receives: Drug: Test toothpaste with nano-HAP and (Potassium Nitrate) KNO3 |
| Control toothpaste without nano-HAP | Placebo comparator | Participants will be instructed to apply a full ribbon of toothpaste to a damp toothbrush. Participants will then brush for 2 minutes followed by rinsing with 15 mL of water. Participants will be instructed not to eat or drink for 30 minutes following brushing. Brushing will be performed twice a day (morning and evening). Receives: Drug: Control toothpaste without nano-HAP |
| Test toothpaste with nano-HAP (medium concentration) | Experimental | Participants will be instructed to apply a full ribbon of toothpaste to a damp toothbrush. Participants will then brush for 2 minutes followed by rinsing with 15 mL of water. Participants will be instructed not to eat or drink for 30 minutes following brushing. Brushing will be performed twice a day (morning and evening). Receives: Drug: Test toothpaste with nano-HAP (medium concentration) |
| Test cream with nano-HAP (higher concentration) | Experimental | Participants will be instructed to brush for 2 minutes morning and evening with a full ribbon of standard fluoride toothpaste. After the evening brushing, participants will then insert custom-made trays loaded with a full ribbon of cream. Participants will be instructed to remove the trays after 5 minutes and expectorate the cream. Participants will be instructed not to eat or drink until the next morning following cream use. Receives: Drug: Test cream with nano-HAP (higher concentration) |
| Control cream without nano-HAP | Placebo comparator | Participants will be instructed to brush for 2 minutes morning and evening with a full ribbon of standard fluoride toothpaste. After the evening brushing, participants will then insert custom-made trays loaded with a full ribbon of cream. Participants will be instructed to remove the trays after 5 minutes and expectorate the cream. Participants will be instructed not to eat or drink until the next morning following cream use. Receives: Drug: Control cream without nano-HAP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage Change From Baseline in VAS (Visual Analog Scale) With Air Stimulation
Patient's response to an air stimulus is recorded on a Visual Analog Scale of 0-100 with 0 representing no pain and 100 representing the worst possible pain.
Measured: Baseline to 8 weeks
Percentage Change From Baseline in VAS (Visual Analog Scale) With Cold Stimulation
Patient's response to cold stimulus is recorded on a Visual Analog Scale of 0-100 with 0 signifying no pain and 100 signifying the worst possible pain
Measured: Baseline to 8 weeks
Percentage Change From Baseline in DPS (Dental Pain Scale) With Air Stimulation
Patient's response to an air stimulus is recorded on a Dental Pain Scale (none[1]-mild[2]-moderate[3]-severe[4]).
Measured: Baseline to 8 weeks
Percentage Change From Baseline in DPS (Dental Pain Scale) With Cold Stimulation
Patient's response to an cold stimulus is recorded on a Dental Pain Scale (none[1]-mild[2]-moderate[3]-severe[4]).
Measured: Baseline to 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2016 (estimated)
- Study startMay 2015
- Primary completionSep 2016
- Study completionSep 2016
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.
- Publications (7)Papers the sponsor has linked to this study.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 203 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, The University of Texas Health Science Center at San Antonio
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02918617
- Sponsor's protocol ID
- HSC20150221H
- Status last verified
- Oct 2018
- First submitted
- 13 Sep 2016
- Last updated
- 16 Nov 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Clark GE, Troullos ES. Designing hypersensitivity clinical studies. Dent Clin North Am. 1990 Jul;34(3):531-44.
PubMed 2197126Gillam DG, Bulman JS, Jackson RJ, Newman HN. Efficacy of a potassium nitrate mouthwash in alleviating cervical dentine sensitivity (CDS). J Clin Periodontol. 1996 Nov;23(11):993-7. doi: 10.1111/j.1600-051x.1996.tb00526.x.
PubMed 8951626Kakar A. A novel computer program for visual analogue scale (VAS). Journal of Dental Research 88 (Special Issue A): 1952, 2009.
Huskisson EC. Measurement of pain. Lancet. 1974 Nov 9;2(7889):1127-31. doi: 10.1016/s0140-6736(74)90884-8. No abstract available.
PubMed 4139420Orro M, Truong T, De Vizio W, Miller S, Chu TC, Boylan D. Thermodontic stimulator--a new technology for assessment of thermal dentinal hypersensitivity. J Clin Dent. 1994;5 Spec No:83-6.
PubMed 8534379Schiff T, Dotson M, Cohen S, De Vizio W, McCool J, Volpe A. Efficacy of a dentifrice containing potassium nitrate, soluble pyrophosphate, PVM/MA copolymer, and sodium fluoride on dentinal hypersensitivity: a twelve-week clinical study. J Clin Dent. 1994;5 Spec No:87-92.
PubMed 8534380Ayad F, Ayad N, Delgado E, Zhang YP, DeVizio W, Cummins D, Mateo LR. Comparing the efficacy in providing instant relief of dentin hypersensitivity of a new toothpaste containing 8.0% arginine, calcium carbonate, and 1450 ppm fluoride to a benchmark desensitizing toothpaste containing 2% potassium ion and 1450 ppm fluoride, and to a control toothpaste with 1450 ppm fluoride: a three-day clinical study in Mississauga, Canada. J Clin Dent. 2009;20(4):115-22.
PubMed 19831164
Study at a glance
From the registry record, last updated by the sponsor on 16 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Efficacy in Relieving Dentin Hypersensitivity of Nanohydroxyapatite-Containing Toothpastes and Cream
- ClinicalTrials.gov ID
- NCT02918617
- Acronym / sponsor ID
- HSC20150221H
- Conditions
- Dentin Sensitivity
- Keywords
- dentin hypersensitivity, nanohydroxyapatite, calcium sodium phosphosilicate, toothpaste, tooth cream
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 203 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center at San AntonioUniversity, hospital or other
- Collaborators
- Sangi Co., Ltd.
- Study start
- May 2015 (actual)
- Primary completion
- Sep 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 29 Sep 2016 (estimated)
- Results
- Posted 16 Nov 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will investigate the effectiveness of nanohydroxyapatite (nano-HAP)-containing toothpastes and cream to relieve dentin hypersensitivity, comparing it with those of a commercial desensitizing dentifrice containing calcium sodium phosphosilicate (Novamin® technology) and a standard fluoride dentifrice containing 1,500 ppm fluoride as sodium monofluorophosphate (MFP).
Detailed description
This is a double-blind, randomized, controlled, parallel group, outpatient clinical trial, involving a total of 270 patients diagnosed with dentin hypersensitivity, who will be randomly assigned to nine treatment groups of 30 patients each. Males or females of age 18 to 80 years will be enrolled. The nine groups will be randomly assigned to use one of the nine test products: (1) toothpaste containing nano-HAP (high concentration); (2) toothpaste containing nano-HAP (low concentration); (3) toothpaste containing nano-HAP and potassium nitrate (KNO3); (4) toothpaste containing NovaMin; (5) standard fluoride toothpaste with 1500 ppm MFP; (6) toothpaste containing nano-HAP (medium concentration); (7) placebo toothpaste; (8) cream containing nano-HAP; (9) placebo cream. Subjects will be instructed to use the study toothpaste as their sole oral hygiene product for the 8 weeks treatment duration while the cream will be applied with a retainer tray for 5 minutes before bed at night. For those using toothpastes, subjects will be instructed to brush their teeth twice daily for 2 minutes, morning and last thing before bed, applying on each occasion a one-inch strip of their assigned toothpaste on a wetted commercially available soft-bristled toothbrush. Dentin hypersensitivity examination, which will include air blast sensitivity and cold thermal sensitivity combined with visual analog scale and Dental Pain Scale, will be conducted at baseline, 2, 4, 6, and 8 weeks. Subjects will be screened for adverse effects on every visit, and all observed adverse events will be recorded when they occur.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 9
| Arm | Type | Receives |
|---|---|---|
| Control toothpaste containing Novamin® technology | Active comparator | Drug: Control toothpaste containing Novamin® technologyParticipants will be instructed to apply a full ribbon of toothpaste to a damp toothbrush. Participants will then brush for 2 minutes followed by rinsing with 15 mL of water. Participants will be instructed not to eat or drink for 30 minutes following brushing. Brushing will be performed twice a day (morning and evening). |
| Control toothpaste containing 1500 ppm fluoride as MFP | Placebo comparator | Drug: Control toothpaste containing 1500 ppm fluoride as MFPParticipants will be instructed to apply a full ribbon of toothpaste to a damp toothbrush. Participants will then brush for 2 minutes followed by rinsing with 15 mL of water. Participants will be instructed not to eat or drink for 30 minutes following brushing. Brushing will be performed twice a day (morning and evening). |
| Test toothpaste with nano-HAP (high concentration) | Experimental | Drug: Test toothpaste with nano-HAP (high concentration)Participants will be instructed to apply a full ribbon of toothpaste to a damp toothbrush. Participants will then brush for 2 minutes followed by rinsing with 15 mL of water. Participants will be instructed not to eat or drink for 30 minutes following brushing. Brushing will be performed twice a day (morning and evening). |
| Test toothpaste with nano-HAP (low concentration) | Experimental | Drug: Test toothpaste with nano-HAP (low concentration)Participants will be instructed to apply a full ribbon of toothpaste to a damp toothbrush. Participants will then brush for 2 minutes followed by rinsing with 15 mL of water. Participants will be instructed not to eat or drink for 30 minutes following brushing. Brushing will be performed twice a day (morning and evening). |
| Test toothpaste with nano-HAP and potassium nitrate (KNO3) | Experimental | Drug: Test toothpaste with nano-HAP and (Potassium Nitrate) KNO3Participants will be instructed to apply a full ribbon of toothpaste to a damp toothbrush. Participants will then brush for 2 minutes followed by rinsing with 15 mL of water. Participants will be instructed not to eat or drink for 30 minutes following brushing. Brushing will be performed twice a day (morning and evening). |
| Control toothpaste without nano-HAP | Placebo comparator | Drug: Control toothpaste without nano-HAPParticipants will be instructed to apply a full ribbon of toothpaste to a damp toothbrush. Participants will then brush for 2 minutes followed by rinsing with 15 mL of water. Participants will be instructed not to eat or drink for 30 minutes following brushing. Brushing will be performed twice a day (morning and evening). |
| Test toothpaste with nano-HAP (medium concentration) | Experimental | Drug: Test toothpaste with nano-HAP (medium concentration)Participants will be instructed to apply a full ribbon of toothpaste to a damp toothbrush. Participants will then brush for 2 minutes followed by rinsing with 15 mL of water. Participants will be instructed not to eat or drink for 30 minutes following brushing. Brushing will be performed twice a day (morning and evening). |
| Test cream with nano-HAP (higher concentration) | Experimental | Drug: Test cream with nano-HAP (higher concentration)Participants will be instructed to brush for 2 minutes morning and evening with a full ribbon of standard fluoride toothpaste. After the evening brushing, participants will then insert custom-made trays loaded with a full ribbon of cream. Participants will be instructed to remove the trays after 5 minutes and expectorate the cream. Participants will be instructed not to eat or drink until the next morning following cream use. |
| Control cream without nano-HAP | Placebo comparator | Drug: Control cream without nano-HAPParticipants will be instructed to brush for 2 minutes morning and evening with a full ribbon of standard fluoride toothpaste. After the evening brushing, participants will then insert custom-made trays loaded with a full ribbon of cream. Participants will be instructed to remove the trays after 5 minutes and expectorate the cream. Participants will be instructed not to eat or drink until the next morning following cream use. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Must be between the ages of 18 and 80, inclusive
- Must be in good general health based on medical history and oral soft and hard tissue examinations
- Must be willing and able to provide informed consent
- Must be able to read and comprehend study materials
- Must have access to a phone for regular study contact
Key exclusion criteria (24 listed)
- Subjects who answer YES to any of the following questions will not be enrolled into the study:
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 |
|---|---|---|
| Control toothpaste containing Novamin® technology | Drug | Control toothpaste containing Novamin® technology |
| Control toothpaste containing 1500 ppm fluoride as MFP | Drug | Control toothpaste containing 1500 ppm fluoride as MFP |
| Test toothpaste with nano-HAP (high concentration) | Drug | Test toothpaste with nano-HAP (high concentration) |
| Test toothpaste with nano-HAP (low concentration) | Drug | Test toothpaste with nano-HAP (low concentration) |
| Test toothpaste with nano-HAP and (Potassium Nitrate) KNO3 | Drug | Test toothpaste with nano-HAP and potassium nitrate (KNO3) |
| Control toothpaste without nano-HAP | Drug | Control toothpaste without nano-HAP |
| Test toothpaste with nano-HAP (medium concentration) | Drug | Test toothpaste with nano-HAP (medium concentration) |
| Test cream with nano-HAP (higher concentration) | Drug | Test cream with nano-HAP (higher concentration) |
| Control cream without nano-HAP | Drug | Control cream without nano-HAP |
Primary outcome
Percentage Change From Baseline in VAS (Visual Analog Scale) With Air Stimulation
Time frame: Baseline to 8 weeks
Patient's response to an air stimulus is recorded on a Visual Analog Scale of 0-100 with 0 representing no pain and 100 representing the worst possible pain.
Percentage Change From Baseline in VAS (Visual Analog Scale) With Cold Stimulation
Time frame: Baseline to 8 weeks
Patient's response to cold stimulus is recorded on a Visual Analog Scale of 0-100 with 0 signifying no pain and 100 signifying the worst possible pain
Percentage Change From Baseline in DPS (Dental Pain Scale) With Air Stimulation
Time frame: Baseline to 8 weeks
Patient's response to an air stimulus is recorded on a Dental Pain Scale (none[1]-mild[2]-moderate[3]-severe[4]).
Percentage Change From Baseline in DPS (Dental Pain Scale) With Cold Stimulation
Time frame: Baseline to 8 weeks
Patient's response to an cold stimulus is recorded on a Dental Pain Scale (none[1]-mild[2]-moderate[3]-severe[4]).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Nov 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 2197126Clark GE, Troullos ES. Designing hypersensitivity clinical studies. Dent Clin North Am. 1990 Jul;34(3):531-44.
- Background: PubMed 8951626Gillam DG, Bulman JS, Jackson RJ, Newman HN. Efficacy of a potassium nitrate mouthwash in alleviating cervical dentine sensitivity (CDS). J Clin Periodontol. 1996 Nov;23(11):993-7. doi: 10.1111/j.1600-051x.1996.tb00526.x.
- BackgroundKakar A. A novel computer program for visual analogue scale (VAS). Journal of Dental Research 88 (Special Issue A): 1952, 2009.
- Background: PubMed 4139420Huskisson EC. Measurement of pain. Lancet. 1974 Nov 9;2(7889):1127-31. doi: 10.1016/s0140-6736(74)90884-8. No abstract available.
- Background: PubMed 8534379Orro M, Truong T, De Vizio W, Miller S, Chu TC, Boylan D. Thermodontic stimulator--a new technology for assessment of thermal dentinal hypersensitivity. J Clin Dent. 1994;5 Spec No:83-6.
- Background: PubMed 8534380Schiff T, Dotson M, Cohen S, De Vizio W, McCool J, Volpe A. Efficacy of a dentifrice containing potassium nitrate, soluble pyrophosphate, PVM/MA copolymer, and sodium fluoride on dentinal hypersensitivity: a twelve-week clinical study. J Clin Dent. 1994;5 Spec No:87-92.
- Background: PubMed 19831164Ayad F, Ayad N, Delgado E, Zhang YP, DeVizio W, Cummins D, Mateo LR. Comparing the efficacy in providing instant relief of dentin hypersensitivity of a new toothpaste containing 8.0% arginine, calcium carbonate, and 1450 ppm fluoride to a benchmark desensitizing toothpaste containing 2% potassium ion and 1450 ppm fluoride, and to a control toothpaste with 1450 ppm fluoride: a three-day clinical study in Mississauga, Canada. J Clin Dent. 2009;20(4):115-22.
- 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.
Bennett T Amaechi, BDS, MS, PhD principal investigator
The University of Texas Health Science Center 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 Phase 2 study testing Test toothpaste with nano-HAP (high concentration), Test toothpaste with nano-HAP (low concentration) and Test toothpaste with nano-HAP and (Potassium Nitrate) KNO3 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 10 inclusion and 24 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 Nov 2018. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 Nov 2018). 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?
Percentage Change From Baseline in VAS (Visual Analog Scale) With Air Stimulation (time frame: Baseline to 8 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02918617, which also lists 7 linked publications.
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 Nov 2018.