Clinical Trial: Effectiveness of a Homecare Dentin Hypersensitivity Gel

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: EFFECTIVENESS OF A HOMECARE DESENSITIZER FOR PATIENTS WITH DENTIN HYPERSENSITIVITY

Brief 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 Summary:

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
Sponsor: Universidade Federal de Santa Maria

Current Primary Outcome:

  • dentine hypersensitivity with visual analog scale (VAS) following tactile, thermal and osmotic stimulus [ Time Frame: Change from Baseline in VAS Scale at 7 days. ]
    The DH was measured on 7 days after products use. It was evaluated on the buccal surface of the tooth selected using a visual analog scale (VAS) immediately after application of the air jet, created with the triple syringe, at a distance of 10 mm from the tooth for 10 seconds, in the region of exposure root. The touch test was performed on the exposed root surface by applying a light force with blunt probe perpendicular to the long axis of the tooth for 10 seconds. Finally, we applied the test with water jet, using the perpendicular triple syringe and spaced 10 mm of the tooth to be tested. DH evaluations were performed with an interval of 1 minute to minimize interactions between examinations. All reviews of DH were conducted by a single trained examiner (M.M.).
  • dentine hypersensitivity with visual analog scale (VAS) following tactile, thermal and osmotic stimulus [ Time Frame: Change from Baseline in VAS Scale at 15 days. ]
    he DH was measured on 15 days after products use. It was evaluated on the buccal surface of the tooth selected using a visual analog scale (VAS) immediately after application of the air jet, created with the triple syringe, at a distance of 10 mm from the tooth for 10 seconds, in the region of exposure root. The touch test was performed on the exposed root surface by applying a light force with blunt probe perpendicular to the long axis of the tooth for 10 seconds. Finally, we applied the test with water jet, using the perpendicular triple syringe and spaced 10 mm of the tooth to be tested. DH evaluations were performed with an interval of 1 min

    Original Primary Outcome: Same as current

    Current Secondary Outcome:

    • Irritation [ Time Frame: Change from Baseline in possible adverse reactions at 7 days. ]
      Irritation was measures by interview and by clinical exam.
    • Irritation [ Time Frame: Change from Baseline in possible adverse reactions at 15 days. ]
      Irritation was measures by interview and by clinical exam.
    • Irritation [ Time Frame: Change from Baseline in possible adverse reactions at 30 days. ]
      Irritation was measures by interview and by clinical exam.
    • Allergy [ Time Frame: Change from Baseline in possible adverse reactions at 07 days. ]
      Irritation was measures by interview and by clinical exam.
    • Allergy [ Time Frame: Change from Baseline in possible adverse reactions at 15 days. ]
      Irritation was measures by interview and by clinical exam.
    • Allergy [ Time Frame: Change from Baseline in possible adverse reactions at 30 days. ]
      Irritation was measures by interview and by clinical exam.
    • Bad taste [ Time Frame: Change from Baseline in possible adverse reactions at 07 days. ]
      Irritation was measures by interview.
    • Bad taste [ Time Frame: Change from Baseline in possible adverse reactions at 30 days. ]
      Irritation was measures by interview.


    Original Secondary Outcome: Same as current

    Information By: Universidade Federal de Santa Maria

    Dates:
    Date Received: April 25, 2014
    Date Started: November 2009
    Date Completion:
    Last Updated: April 29, 2014
    Last Verified: April 2014