Effectiveness of a Homecare Dentin Hypersensitivity Gel
Condition: Dentin Sensitivity
MeSH terms: Dentin Sensitivity; Hypersensitivity
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Aim: To evaluate the effectiveness of a desensitizing gel for topical and home use in the
      treatment of dentin hypersensitivity (DH) through a randomized clinical trial, double-blind,
      with three parallel treatment. Methods: 126 subjects were divided into three groups: placebo
      gel (PG), test gel (TG) (5% sodium fluoride, potassium oxalate 5%, strontium chloride 10%)
      and sodium fluoride gel (2% FG ). The measurement of DH was performed by a single examiner
      blinded by the visual analog scale (VAS) after tactile, thermal and osmotic stimuli in the
      Baseline, 7, 15 and 30 days.
    

Detailed description: 
      STUDY POPULATION

      The sample was recruited in clinics of the School of Dentistry at the Franciscan University
      Center and the specialization course in Periodontics at the University of Inga - . St. Mary
      (UNINGÁ). After the selection of patients, issues related to medical and dental history were
      collected through a semi-structured questionnaire. Subsequently, in teeth included in the
      study, conducted the assessment of gingival recession and the width and depth (in the case of
      the presence of non-carious cervical lesions) in millimeters with a millimeter probe type
      Willians (Neumar®, São Paulo , SP , Brazil) to estimate the area of wear in mm3. Still, the
      recession of each subject was classified according to its probable etiology and associated
      with periodontal disease (recession on the buccal surface and proximal surfaces on the teeth
      with DH in a subject with attachment loss ≥ 3 mm and probing depth ≥ 3mm affecting
      interproximal sites of two non-adjacent or more teeth). The others were considered associated
      with brushing trauma.

      SAMPLE SIZE

      The calculation of sample size was based on a clinically significant difference between two
      groups in the reduction of DH after stimulation with compressed air (mean difference of 20 mm
      and a standard deviation of 30mm on a visual analog scale). Considering a significance level
      of 5%, power 80% of the study and design in parallel, were estimated at least 36 patients for
      each group. Considering a dropout rate of 15% of the study, the size was increased to 42
      eligible individuals per group.

      RANDOMIZATION

      Eligible patients were randomized in blocks in the form of allotment into three groups. For
      this, they were placed in a manila envelope with 2 papers with each letter "A", "B" and "C".
      The draw was always held by a third person (R.A.), which also gave the gel to the patient.
      All envelopes were sequentially numbered and were sealed. The sequential envelope was opened
      only after the draw of the six letters of the previous envelope.

      BLINDING

      The study was completely double-blind. At no time patients had access to that type of product
      was gel "A", "B" or "C". The evaluator of DH in no time knew what the gel ("A", "B" or "C")
      each patient was using. For this, the investigators asked the patients and the evaluator not
      talked about which product code they were using. In order to maintain blinding,
      randomization, control of compliance and verification of possible adverse reactions was
      performed by another reviewer (R.A.).

      EXPERIMENTAL PROCEDURES

      At Baseline, all patients received a supragingival prophylaxis with a rubber cup (Microdont®,
      São Paulo , SP , Brazil) and prophylactic paste (Villevie® , Joinville , SC , Brazil) . The
      products tested were always delivered in a transparent plastic syringe with 10 mls marking
      identified by the letters "A" , " B " or " C " . The syringes were given to individuals in an
      opaque plastic envelope sealed and delivered along with a reminder of the correct way to use
      the products. Guidance for the use of substances was to make application with a new
      toothbrush, 1 time a day (at night, before bed, after brushing the teeth) with the product
      received, for 1 minute and the amount of 0.25 g (0.5 ml) of the product as the demarcation
      the syringe. It was recommended that after using the products, they were expelled without
      rinsing the oral cavity with water.

      All the dependet variables (Primary and secundary) were evaluated at baseline, 7, 15 and 30
      days. A week before the baseline study, a dentifrice (Colgate Triple Action, Colgate -
      Palmolive , São Paulo , Brazil; 1450 ppm fluoride, abrasives: calcium carbonate , sodium
      bicarbonate and sodium silicate) was made available to all patients. This wash-out period was
      adopted to minimize interference from any other product with specific action to DH during the
      trial period. At baseline, was made available to all participants a new soft-bristled
      toothbrush, tufts in one direction and bristles rounded finish (professional Colgate Extra
      Clean , Colgate - Palmolive , São Paulo , Brazil). It was recommended that oral hygiene was
      performed three times a day just with toothbrush, toothpaste and floss without the use of
      mouthwashes. They recommended the use of 0.5 grams of toothpaste on the brush (Fill in the
      horizontal width of the brush with toothpaste).

      Survey participants were instructed to return to the reviews of 7, 15 and 30 days bringing
      their new toothbrush, so was performed plaque removal site before testing the DH.

      COMPLIANCE CONTROL

      It was initially demonstrated by examining the amount of product to be used with an empty
      syringe. Adherence to treatment was performed with the control of the use of the substance by
      the inner end of the syringe plunger. In each evaluation, the patient returned with a syringe
      containing part of the product. In 7-day trial syringe should be rolled 6.5 ml, 2.5 ml at 15
      days (in this assessment the patient received another syringe containing 5ml of the product),
      and at 30 days the two syringes should be empty. To maintain blinding of the examiner, the
      control of adherence was performed by the same person who made the randomization (R.A.).

      DATA ANALYSIS

      The unit of analysis was the individual. Means and 95% confidence intervals of the VASs in
      different stimuli were described for each group and experimental time. It was also verified
      the reduction of DH by subtracting the VAS of day 30 for the baseline VAS (delta) for each
      experimental group. After the data normality test, nonparametric tests were applied. Mean
      VASs of each experimental group were compared using the Kruskal-Wallis and Mann-Whitney test.
      Within-group analyzes at different time points were compared using the Wilcoxon test. Still,
      the VAS was dichotomized to "Take Pain" (VAS ≤ 25) and "Moderate pain / severe" (VAS> 25) and
      intergroup comparisons were performed using chi-square test. The level of significance was
      set at 5%. Data were analyzed by statistical software PASW Statistics Data Editor 17.0
      (Statistical Package for the Social Sciences, PASW, Chicago, Ill).
    

Intervention name(s): placebo gel; 5% sodium fluoride, potassium oxalate 5%, strontium chloride 10%; Fluoride neutral NaF gel 2 %
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Manipulated at Novaderme ®, Santa Maria, RS, Brazil.; Manipulated at Novaderme ®, Santa Maria, RS, Brazil.; The product had similar appearance and viscosity than others.
Other intervention name(s): The product (Treatment "A") was manipulated.; The product (Treatment "B") was manipulated with the three active agents.; Flugel®, DFL, Rio de Janeiro, Brazil;
Intervention MeSH terms: Listerine; Fluorides; Sodium Fluoride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Dentin hypersensitivity; Dentin Sensitivities