NCT02918617

Brief 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 containing 1,500 ppm fluoride as sodium monofluorophosphate (MFP).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
203

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started May 2015

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2015

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2016

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

September 13, 2016

Completed
16 days until next milestone

First Posted

Study publicly available on registry

September 29, 2016

Completed
2.1 years until next milestone

Results Posted

Study results publicly available

November 16, 2018

Completed
Last Updated

November 16, 2018

Status Verified

October 1, 2018

Enrollment Period

1.3 years

First QC Date

September 13, 2016

Results QC Date

August 21, 2018

Last Update Submit

October 18, 2018

Conditions

Dentin Sensitivity

Keywords

dentin hypersensitivitynanohydroxyapatitecalcium sodium phosphosilicatetoothpastetooth cream

Outcome Measures

Primary Outcomes (4)

  • 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.

    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

    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\[4\]).

    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\[4\]).

    Baseline to 8 weeks

Study Arms (9)

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).

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).

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).

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).

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).

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).

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).

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.

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.

Drug: Control cream without nano-HAP

Interventions

Control toothpaste containing Novamin® technologyDRUG
Control toothpaste containing Novamin® technology
Control toothpaste containing 1500 ppm fluoride as MFPDRUG
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) KNO3DRUG
Test toothpaste with nano-HAP and potassium nitrate (KNO3)
Control toothpaste without nano-HAPDRUG
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-HAPDRUG
Control cream without nano-HAP

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.
  • 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).

You may not qualify if:

  • 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?
  • 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?
  • +9 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

School of Dentistry, University of Texas Health Science Center

San Antonio, Texas, 78229, United States

Location

Related Publications (7)

  • Clark GE, Troullos ES. Designing hypersensitivity clinical studies. Dent Clin North Am. 1990 Jul;34(3):531-44.

    PMID: 2197126BACKGROUND

  • Gillam 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.

    PMID: 8951626BACKGROUND

  • Kakar A. A novel computer program for visual analogue scale (VAS). Journal of Dental Research 88 (Special Issue A): 1952, 2009.

    BACKGROUND

  • Huskisson EC. Measurement of pain. Lancet. 1974 Nov 9;2(7889):1127-31. doi: 10.1016/s0140-6736(74)90884-8. No abstract available.

    PMID: 4139420BACKGROUND

  • Orro 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.

    PMID: 8534379BACKGROUND

  • Schiff 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.

    PMID: 8534380BACKGROUND

  • Ayad 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.

    PMID: 19831164BACKGROUND

MeSH Terms

Conditions

Dentin Sensitivity

Interventions

potassium nitrate

Condition Hierarchy (Ancestors)

Tooth DiseasesStomatognathic Diseases

Results Point of Contact

Title
Bennett Amaechi, DDS
Organization
University of Texas Health San Antonio
amaechi@uthscsa.edu
210-567-3185

Study Officials

  • Bennett T Amaechi, BDS, MS, PhD

    University of Texas Health Science Center San Antonio

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, Department of Comprehensive Dentistry

Study Record Dates

First Submitted

September 13, 2016

First Posted

September 29, 2016

Study Start

May 1, 2015

Primary Completion

September 1, 2016

Study Completion

September 1, 2016

Last Updated

November 16, 2018

Results First Posted

November 16, 2018

Record last verified: 2018-10

Data Sharing

IPD Sharing
Will not share

Locations

US(1)