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Effectiveness of a Homecare Dentin Hypersensitivity Gel (ECR)

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ClinicalTrials.gov Identifier: NCT02128633
Recruitment Status : Completed
First Posted : May 1, 2014
Last Update Posted : May 1, 2014
Sponsor:
Collaborator:
Franciscan University Center
Information provided by (Responsible Party):
Fabricio Batistin Zanatta, Universidade Federal de Santa Maria

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.

Condition or disease Intervention/treatment Phase
Dentin Sensitivity Drug: placebo gel Drug: 5% sodium fluoride, potassium oxalate 5%, strontium chloride 10% Drug: Fluoride neutral NaF gel 2 % Phase 2 Phase 3

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 126 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: EFFECTIVENESS OF A HOMECARE DESENSITIZER FOR PATIENTS WITH DENTIN HYPERSENSITIVITY
Study Start Date : November 2009
Actual Primary Completion Date : June 2013
Actual Study Completion Date : March 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Allergy Potassium
Drug Information available for: Fluoride

Arm Intervention/treatment
Placebo Comparator: placebo
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
Manipulated at Novaderme ®, Santa Maria, RS, Brazil.
Other Name: The product (Treatment "A") was manipulated.

Experimental: Experimental gel
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%
Manipulated at Novaderme ®, Santa Maria, RS, Brazil.
Other Name: The product (Treatment "B") was manipulated with the three active agents.

Active Comparator: Positive control
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 %
The product had similar appearance and viscosity than others.
Other Name: Flugel®, DFL, Rio de Janeiro, Brazil;




Primary Outcome Measures :
  1. 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.).

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

  3. dentine hypersensitivity with visual analog scale (VAS) following tactile, thermal and osmotic stimulus [ Time Frame: Change from Baseline in VAS Scale at 30 days. ]
    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.).


Secondary Outcome Measures :
  1. Irritation [ Time Frame: Change from Baseline in possible adverse reactions at 7 days. ]
    Irritation was measures by interview and by clinical exam.

  2. Irritation [ Time Frame: Change from Baseline in possible adverse reactions at 15 days. ]
    Irritation was measures by interview and by clinical exam.

  3. Irritation [ Time Frame: Change from Baseline in possible adverse reactions at 30 days. ]
    Irritation was measures by interview and by clinical exam.

  4. Allergy [ Time Frame: Change from Baseline in possible adverse reactions at 07 days. ]
    Irritation was measures by interview and by clinical exam.

  5. Allergy [ Time Frame: Change from Baseline in possible adverse reactions at 15 days. ]
    Irritation was measures by interview and by clinical exam.

  6. Allergy [ Time Frame: Change from Baseline in possible adverse reactions at 30 days. ]
    Irritation was measures by interview and by clinical exam.

  7. Bad taste [ Time Frame: Change from Baseline in possible adverse reactions at 07 days. ]
    Irritation was measures by interview.

  8. Bad taste [ Time Frame: Change from Baseline in possible adverse reactions at 30 days. ]
    Irritation was measures by interview.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02128633


Locations
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Brazil
Fabricio Batistin Zanatta
Santa Maria, Rua Floriano Peixoto--, Brazil, 97015-372
Sponsors and Collaborators
Universidade Federal de Santa Maria
Franciscan University Center
Investigators
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Study Director: Fabricio B Zanatta, pHD Universidade Federal de Santa Maria
Study Chair: ALESSANDRA P GRELLMANN, DS Universidade Federal de Santa Maria
Study Chair: ROBERTO C VIANNA SANTOS, pHD Centro Universitário Franciscano

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Responsible Party: Fabricio Batistin Zanatta, Orientador principal, Universidade Federal de Santa Maria
ClinicalTrials.gov Identifier: NCT02128633     History of Changes
Other Study ID Numbers: SM_DH_2014
First Posted: May 1, 2014    Key Record Dates
Last Update Posted: May 1, 2014
Last Verified: April 2014

Keywords provided by Fabricio Batistin Zanatta, Universidade Federal de Santa Maria:
Dentin hypersensitivity
Dentin Sensitivities

Additional relevant MeSH terms:
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Hypersensitivity
Dentin Sensitivity
Immune System Diseases
Tooth Diseases
Stomatognathic Diseases
Fluorides
Sodium Fluoride
Listerine
Cariostatic Agents
Protective Agents
Physiological Effects of Drugs
Anti-Infective Agents, Local
Anti-Infective Agents