Not Yet RecruitingPhase 4ACTRN12610001050044

Potential of Functionalised tri-Calcium Phosphate in the relief of dentine hypersensitivity

The capacity of fTPC [Functionalised tri-Calcium Phosphate] to enhance the ability of fluoride in relieving dentine hypersensitivity


Sponsor

Dr. Steven Naoum

Enrollment

140 participants

Start Date

Dec 1, 2010

Study Type

Interventional

Conditions

Summary

Introduction The currently accepted definition of dentine hypersensitivity states that ‘Dentine hypersensitivity is characterized by short, sharp pain arising from exposed dentin in response to stimuli, typically thermal, evaporative, tactile, osmotic, or chemical, and which cannot be ascribed to any other form of dental defect or disease.’ The hydrodynamic theory is the most widely demonstrated and accepted pathophysiological theory of dentine hypersensitivity. The theorem proposes that dentine hypersensitivity is a result of movement of fluid within the dentine tubules. Most pain-producing stimuli cause movement of dentinal tubule fluid, the most common being cold and evaporative stimuli. This results in a pressure change across the dentin which activates intra-dental nociceptive nerve fibers, via a mechanoreceptor response, to cause pain. Currently available dentine desensitisers can be divided into two categories by their modus operandi: one is to interrupt the neural response to pain stimuli; the other is to occlude open tubules to block the hydrodynamic mechanism. Clinpro Tooth Creme is a white paste that contains 950 ppm fluoride ion (similar to regular toothpaste) and a functionalised tri-calcium phosphate ingredient Aims 1) Investigate the efficacy of Functionalised tri-Calcium Phosphate in relieving dentine hypersensitivity 2) Assess the efficacy of Functionalised tri-Calcium Phosphate in relieving dentine hypersensitivity in comparison to an alternative desensitising agent 3) Compare the efficacy of Functionalised tri-Calcium Phosphate in relieving dentine hypersensitivity when applied topically and with brushing vs application during brushing only


Eligibility

Sex: Both males and femalesMin Age: 18 YearssMax Age: 70 Yearss

Inclusion Criteria5

  • 18-70 years old
  • In good general health
  • At least 2 teeth with exposed root surface that are responsive on probing with a periodontal probe or a 1 second air blast from triplex . These teeth will not exhibit diagnosed caries, defective restorations or signs of fracture on initial assessment. Also these teeth will not have had dental restorations, periodontal surgery or orthodontics that has resulted in post operative pain in the immediate past 3 months.
  • Patient must read and sign the consent form
  • Patient must be capable and willing to brush teeth at least 2 times a day for 2 min

Exclusion Criteria8

  • Using desensitizing therapy regulary in the 3 months prior to selection
  • Regular medical treatment involving anti inflammatory and analgesic use
  • Pregnant or nursing
  • Allergies to any components used in products involved in testing
  • Eating disorders
  • System diseases causing dental sensitivity
  • Excessive dietary exposure to acids
  • Inability to read the oral hygiene instructions given

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Interventions

The agent being investigated in this study (Clinpro Tooth Creme) utilises a funtionalised tri-calcium phosphate ingredient not currently available in any current dentine desensitizing agents. It is h

The agent being investigated in this study (Clinpro Tooth Creme) utilises a funtionalised tri-calcium phosphate ingredient not currently available in any current dentine desensitizing agents. It is hypothesised that this ingredient enhances the absorption of fluoride, calcium and phosphate into the tooth allowing greater remineralization to occur. In the context of hypersensitvity this increased remineralization will aid in blocking the hydrodynamic pain mechanism Invetervention Group 1: Apply a pea-sized amount of Clinpro Tooth Creme to a soft-bristled toothbrush and brush teeth for 2 minutes twice daily. After brushing, adults should expectorate. Intervention Group 2: Twice daily brushing with a pea-size amount of Tooth Creme AND a directed topical application of Tooth Creme onto sensitive teeth before sleeping without rinsing. The product shall be used for 6 weeks. A 6 week period has been shown as providing sufficient time to allow maximum benefit of a desensitizing product (Ricarte, 2008)


Locations(1)

Australia

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ACTRN12610001050044


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