Effectiveness of a Homecare Dentin Hypersensitivity Gel

• Status: Completed
• Trial end date: 2014-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Universidade Federal de Santa Maria
• Collaborator: Franciscan University Center
• Treatments: Fluorides; Listerine; Sodium Fluoride

Criteria

Inclusion Criteria:

• Eligible individuals who had been considered with a tooth with gingival recession and DH caused by at least one of the stimuli, heat (air), tactile (probe) and/or osmotic (water). If the subject submit more than one tooth with DH, the most sensitive element to the air test was chosen as the unit of analysis. Molars were excluded from analysis.

Exclusion Criteria:

• Ineligible individuals were characterized by exhibiting one of the following conditions:

• Had undergone periodontal surgery in the last three months;

• Chronic use of anti-inflammatory and analgesic,

• Receiving specific treatment for DH,

• Presented hypersensitivity to any of the compounds used in the study;

• Pregnant or lactating;

• Systemic conditions that could cause or predispose the development of DH (oesophageal reflux);

• subjects whose diet submit excess acidic substances;

• Persons whose tooth with DH present carie cavities, fractures, pulp necrosis or some pulp symptoms diagnosed through pulp sensitivity tests to cold;

• Present congenital defects in enamel or dentin;

• Present extensive restoration carried out in the last three months

• Present dental crowns and abutment of fixed or removable prosthesis.

Exclusion criteria after the start of the study:

• Patients who did not returned calls for the achievement of sensitivity tests in the stipulated period;

• Individuals that did not use adequadely the product;

• Subjects that desist from participating in the search, for any reason.

• Participants who presented worsening of DH;

• Subjects that presented some kind of reaction was observed, irritation or allergy to any of the products.