Clinical trial NCT02918617: Clinical Efficacy in Relieving Dentin Hypersensitivity of Nanohydroxyapatite-Containing Toothpastes and Cream
Official title: Clinical Efficacy in Relieving Dentin Hypersensitivity of Nanohydroxyapatite-Containing Toothpastes and Cream
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Dentin Sensitivity
Keywords: dentin hypersensitivity
nanohydroxyapatite
calcium sodium phosphosilicate
toothpaste
tooth cream
Lead sponsor: The University of Texas Health Science Center at San Antonio
Sponsor class: OTHER
Collaborators: name: Sangi Co., Ltd.
First posted: 2016-09-29
Enrollment: 203
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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.

Eligibility criteria: Inclusion Criteria:

* 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).

Exclusion Criteria:

* 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?
  * 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?

Primary outcomes:
measure: Percentage Change From Baseline in VAS (Visual Analog Scale) With Air Stimulation
timeFrame: Baseline to 8 weeks
measure: Percentage Change From Baseline in VAS (Visual Analog Scale) With Cold Stimulation
timeFrame: Baseline to 8 weeks
measure: Percentage Change From Baseline in DPS (Dental Pain Scale) With Air Stimulation
timeFrame: Baseline to 8 weeks
measure: Percentage Change From Baseline in DPS (Dental Pain Scale) With Cold Stimulation
timeFrame: Baseline to 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: San Antonio
country: United States
facility: School of Dentistry, University of Texas Health Science Center
state: Texas
Study officials:
affiliation: University of Texas Health Science Center San Antonio
name: Bennett T Amaechi, BDS, MS, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Kakar A. A novel computer program for visual analogue scale (VAS). Journal of Dental Research 88 (Special Issue A): 1952, 2009.
citation: Huskisson EC. Measurement of pain. Lancet. 1974 Nov 9;2(7889):1127-31. doi: 10.1016/s0140-6736(74)90884-8. No abstract available.
citation: 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.
citation: 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.
citation: 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.