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NCT Number: NCT03851900

A Comparison of Long-Term Effectiveness of Two Desensitizing Products

This randomized, controlled, clinical trial aimed to compare the 6- month clinical performance of a desensitizer that contains calcium phosphate TM with a two-step self-etch adhesive SE and placebo (distilled water). At least 150 teeth wil be treated with desensitizing products and placebo randomly one third usig TM, one third using SE and one third using placebo. The efficiency of the materials will be evaluated at baseline, 1 week, 1 month, 3 months and 6 months after treatment.

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Key information

Conditions

Dentin Hypersensitivity Dentin Sensitivity Stomatognathic Diseases Tooth Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hacettepe University

Ankara, Turkey (Türkiye)

About this study

The aim of this randomized, controlled, clinical trial is to compare the clinical efficacy of a desensitizer that contains calcium phosphate with a two-step self-etch adhesive and placebo through a long-term period (6 months). At least fifty patients with a sensitivity score of 6 or higher, according to the Visual Analog Scale (VAS), with at least three teeth will participate in this study. Teethmate Desensitizer (TM), Clearfil SE Bond 2 (SE) and placebo (distilled water) will be applied randomly to three teeth of each patient. Recalls will be done at baseline, 1 week, 1 month, 3 months and 6 months after treatment by applying air-blast and the sensitivity scores will be determined according to VAS. The efficiency of the materials will be determined according to the VAS scores. Data will be analyzed using Paired t test and repeated measures of ANOVA.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Subjects with 3 or more hypersensitive teeth with a VAS (Visual Analog Scale) score
  • Willingness to participate in the study

Exclusion criteria

  • Subjects are unwilling to participate voluntarily
  • Patients under 18 years old
  • Those that were taking analgesic medicaments
  • Pregnant and breastfeeding females
  • The presence of a systemic disease that affects the participation
  • Teeth with cervical loss of hard tissue that need restoration absolutely
  • Large/defective restoration, caries or enamel cracks in sensitive teeth
  • Teeth with vulnerability to hypersensitivity after root scaling
  • Pulpitis presence.

Treatment and study plan

Teethmate Desensitizer (TM)

Other

Desensitizing agent will be applied to sensitive teeth.

Clearfil SE Bond 2

Other

Desensitizing agent will be applied to sensitive teeth.

Distilled water

Other

Placebo will be applied to sensitive teeth as a negative control.

Primary outcomes

  1. The effectiveness of desensitizers through long-term period

    Time frame: 6 months

    The clinical efficacy of a desensitizer that contains calcium phosphate with a two-step self-etch adhesive and placebo through a long-term period. Evaluation will be performed usig the Visual Analog Scale(VAS). VAS values will be according to the following parameters: 0 - no discomfort;1 to 3 - light discomfort;4 to 6 - mild discomfort;7 to 9 - severe discomfort;10 - Unbearable discomfort. After each stimulus to the suspected site the degree of hypersensitivity will be determined from 6 to 10 as the preop VAS score for each individual painful tooth.

Secondary outcomes

  1. Subjective satisfaction of patients

    Time frame: 6 months

    Because of the patient-centered aspect of the study patients' subjective satisfaction will be prior. Patients will be asked to define their sensitivity according to Visual Analog Scale (VAS) scale. VAS values will be according to the following parameters:

    0 - no discomfort;1 to 3 - light discomfort;4 to 6 - mild discomfort;7 to 9 - severe discomfort;10 - Unbearable discomfort. In case of persistant or recurrent sensitivity reported by the participants after application of desensitizing agents or placebo, even if the Visual Analog Scale score was decreased, it was accepted as failure, so alternative hypersensitivity treatments applied and current teeth will be excluded.

Sponsors and collaborators

Lead sponsor

Baskent University

Other

Collaborators

  • Hacettepe University

Registry information

Official study title

A Comparison of Long-Term Effectiveness of Two Desensitizing Products: A Randomized Clinical Placebo-Controlled Study

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Feb 22, 2019
Registry last updated
Oct 3, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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