Clinical Efficacy in Relieving Dentin Hypersensitivity of Nanohydroxyapatite-Containing Toothpastes and Cream
Condition: Dentin Sensitivity
MeSH terms: Dentin Sensitivity; Hypersensitivity
Intervention: 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; Control toothpaste without nano-HAP; Test toothpaste with nano-HAP (medium concentration); Test cream with nano-HAP (higher concentration); Control cream without nano-HAP
Intervention MeSH terms: Fluorides
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 203.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: dentin hypersensitivity; nanohydroxyapatite; calcium sodium phosphosilicate; toothpaste; tooth cream

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).
    

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?