Effectiveness of a Homecare Dentin Hypersensitivity Gel

NCT02128633 | Completed Phase 2 DMC

• 1 other identifier: SM_DH_2014
• Study Type: interventional
• Target: 126
• Locations: 1 country
• Sites: 1

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.

Conditions

Dentin Sensitivity

Keywords

Dentin hypersensitivity; Dentin Sensitivities

Outcome Measures

Primary Outcomes (3)

• dentine hypersensitivity with visual analog scale (VAS) following tactile, thermal and osmotic stimulus

  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.).

  Change from Baseline in VAS Scale at 7 days.

• dentine hypersensitivity with visual analog scale (VAS) following tactile, thermal and osmotic stimulus

  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 minute to minimize interactions between examinations. All reviews of DH were conducted by a single trained examiner (M.M.).

  Change from Baseline in VAS Scale at 15 days.

• dentine hypersensitivity with visual analog scale (VAS) following tactile, thermal and osmotic stimulus

  The DH was measured on 30 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.).

  Change from Baseline in VAS Scale at 30 days.

Secondary Outcomes (8)

• Irritation

  Change from Baseline in possible adverse reactions at 7 days.

• Irritation

  Change from Baseline in possible adverse reactions at 15 days.

• Irritation

  Change from Baseline in possible adverse reactions at 30 days.

• Allergy

  Change from Baseline in possible adverse reactions at 07 days.

• Allergy

  Change from Baseline in possible adverse reactions at 15 days.

Study Arms (3)

placebo

PLACEBO COMPARATOR

Individuals that were randomized for treatment " A " . The product tested were always delivered in a transparent plastic syringe with 10 mls marking identified by the letters " A " . 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 (Placebo gel).

Drug: placebo gel

Experimental gel

EXPERIMENTAL

Individuals that were randomized for treatment " B " - The product was delivered in a transparent plastic syringe with 10 mls identified by the letter " B ". The syringes were given to individuals in an opaque plastic envelope sealed and 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 (5% sodium fluoride, potassium oxalate 5%, strontium chloride 10% ) .

Drug: 5% sodium fluoride, potassium oxalate 5%, strontium chloride 10%

Positive control

ACTIVE COMPARATOR

Individuals that were randomized for treatment " C " . The product tested were always delivered in a transparent plastic syringe with 10 mls marking identified by the letters " 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 (Fluoride neutral NaF gel 2 %).

Drug: Fluoride neutral NaF gel 2 %

Interventions

placebo gel DRUG

Manipulated at Novaderme ®, Santa Maria, RS, Brazil.

Also known as: The product (Treatment "A") was manipulated.

placebo

5% sodium fluoride, potassium oxalate 5%, strontium chloride 10% DRUG

Manipulated at Novaderme ®, Santa Maria, RS, Brazil.

Also known as: The product (Treatment "B") was manipulated with the three active agents.

Experimental gel

Fluoride neutral NaF gel 2 % DRUG

The product had similar appearance and viscosity than others.

Also known as: Flugel®, DFL, Rio de Janeiro, Brazil;

Positive control

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Universidade Federal de Santa Maria: lead
• Franciscan University Center: collaborator

Study Sites (1)

Fabricio Batistin Zanatta

Santa Maria, Rua Floriano Peixoto--, 97015-372, Brazil

Location

MeSH Terms

Conditions

Dentin Sensitivity

Interventions

Sodium Fluoride; Oxalic Acid

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Fluorides; Hydrofluoric Acid; Fluorine Compounds; Inorganic Chemicals; Sodium Compounds; Cariostatic Agents; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture; Oxalates; Dicarboxylic Acids; Acids, Acyclic; Carboxylic Acids; Organic Chemicals

Study Officials

• Fabricio B Zanatta, pHD

  Universidade Federal de Santa Maria

  STUDY DIRECTOR

• ALESSANDRA P GRELLMANN, DS

  Universidade Federal de Santa Maria

  STUDY CHAIR

• ROBERTO C VIANNA SANTOS, pHD

  Centro Universitário Franciscano

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Orientador principal

Study Record Dates

• First Submitted: April 25, 2014
• First Posted: May 1, 2014
• Study Start: November 1, 2009
• Primary Completion: June 1, 2013
• Study Completion: March 1, 2014
• Last Updated: May 1, 2014

Record last verified: 2014-04

Locations

BR (1)