A Comparison of Long-Term Effectiveness of Two Desensitizing Products

Dentin Hypersensitivity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03851900
• Other study ID #: Hacettepe 2017/06-26 KA-16009
• Status: Completed
• Phase: N/A
• Start date: February 1, 2019
• Est. completion date: October 1, 2019

Study information

• Verified date: October 2019
• Source: Baskent University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: October 1, 2019
• Est. primary completion date: October 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

1. Subjects with 3 or more hypersensitive teeth with a VAS (Visual Analog Scale) score

2. Willingness to participate in the study

Exclusion Criteria:

1. Subjects are unwilling to participate voluntarily

2. Patients under 18 years old

3. Those that were taking analgesic medicaments

4. Pregnant and breastfeeding females

5. The presence of a systemic disease that affects the participation

6. Teeth with cervical loss of hard tissue that need restoration absolutely

7. Large/defective restoration, caries or enamel cracks in sensitive teeth

8. Teeth with vulnerability to hypersensitivity after root scaling

9. Pulpitis presence.

Related Conditions & MeSH terms

• Dentin Hypersensitivity
• Dentin Sensitivity
• Hypersensitivity

Intervention

Other:
• Teethmate Desensitizer (TM)
Desensitizing agent will be applied to sensitive teeth.
• Clearfil SE Bond 2
Desensitizing agent will be applied to sensitive teeth.
• Distilled water
Placebo will be applied to sensitive teeth as a negative control.

Locations

Country	Name	City	State
Turkey	Hacettepe University	Ankara

Sponsors (2)

Lead Sponsor	Collaborator
Baskent University	Hacettepe University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The effectiveness of desensitizers through long-term period	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.	6 months
Secondary	Subjective satisfaction of patients	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.	6 months