Effectiveness of Nanohydroxyapetite Paste on Reducing Dentin Hypersensitivity
Condition: Dentin Hypersensitivity
MeSH terms: Dentin Sensitivity; Hypersensitivity
Study type: Interventional
Phase: Phase 4

Summary: 
      The aim of this study is to compare the efficacy of dentine hypersensitivity reduction using
      in office paste formula containing nanoHydroxyapatite with the commercially available
      fluoride (duraphat) and a placebo in treating hypersensitivity in a single visit.
    

Detailed description: 
      Following the approval of the Research Ethics Committee of Riyadh college of Dentistry and
      Pharmacy (The Institutional Review Board), a randomized double blind single treatment
      controlled clinical trial will be carried out on 60 patients (-- males and -- females)
      between the age group of 18 to 45 years, visiting the out-patient clinics of Riyadh Colleges
      of Dentistry and Pharmacy during the period between October and December.

      The protocols for the study will be developed as per the guidelines for the design and
      conduct of clinical trials on dentinal hypersensitivity and in accordance with the
      Declaration of Helsinki and Guidelines for Good Clinical Practice. Prior to the start of the
      study patients will be given both verbal and written information about the process and an
      appropriate signed informed consent form will be obtained.

      Only subjects demonstrating two hypersensitive teeth that satisfied the tactile and airblast
      hypersensitivity enrolment criteria, qualified to participate in the study. Qualified
      subjects will be randomly defined to one of the three study groups in order to have 20
      subjects per treatment group:

        -  Study 1: nanoXIM care paste, fluoride-free (test group)

        -  Study 2: fluoride paste

        -  Study 3: placebo group (positive control group).

      Subjects selected will undergo thorough clinical examination, followed by oral prophylaxis,
      oral hygiene instructions and dietary counseling. After the teeth isolation with cotton
      rolls, changes in the dentin sensitivity to tactile (dental explorer), thermal stimuli (drops
      of melted ice) and air stimuli (blast from dental syringe) will be evaluated. Following
      application of the stimuli, responses will be evaluated and assessed by the Visual Analog
      Scale (VAS). The survey form will be completed by the examiner to have a baseline prior to
      paste application in the first visit. The survey contains five questions, rated on a 10-point
      scale, assessing:

        1. Degree of pain.

        2. Duration of pain.

        3. Intensity of pain.

        4. Tolerability of pain.

        5. Description of pain.

      Data Analysis

      The study patients will be randomly assigned into 3 groups (N, F and P) equal groups of 20.
      The randomization process will be made using a computer-generated random table. Excel
      software (Micro- soft) will be used for randomization. The pastes used on the study labeled
      N, F and P respectively, will be completely wrapped not allowing the pastes applicant or any
      other member of the research team to know what test paste will be applied on the patients.
      The patients will be blinded by not letting them know which agents will be applied. The chief
      investigator, the first author in this study, will coordinate the entire trial and recruited
      the various operators for the same.
    

Intervention name(s): 5% Sodium Fluoride Varnish; 15% Nanohydroxyapetite paste; Glycerol
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 5% sodium fluoride varnish applied on the dentin by the dentist; 15% nanohydoxyapetite paste without potassium nitrate or fluoride applied on the dentin by the dentist; Glycerol with water in a 1: 1 ratio
Other intervention name(s): Duraphat; Nanohydroxyapetite paste; glycerol water mixture
Intervention MeSH terms: Listerine; Fluorides; Sodium Fluoride; Fluorides, Topical; Glycerol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment