A Comparison of Long-Term Effectiveness of Two Desensitizing Products

NCT03851900 | Completed

• 1 other identifier: Hacettepe 2017/06-26 KA-16009
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Dentin Hypersensitivity

Keywords

Dentin hypersensitivity; Randomized clinical trial; Calcium phosphate desensitizer; Adhesive resin; VAS

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Subjective satisfaction of patients

  6 months

Study Arms (3)

Teethmate Desensitizer (TM)

EXPERIMENTAL

Calcium phosphate biomimetic material that forms hydroxyapatite from tetracalcium phosphate and dicalcium phosphate anhydrous and plug the dentin tubules causing remineralization and dentin hypersensitivity relief.

Other: Teethmate Desensitizer (TM)

Clearfil SE Bond 2 (SE)

ACTIVE COMPARATOR

Two-step self etch adhesive resin treating dentin hypersensitivity b covering a film layer after light-curing.

Other: Clearfil SE Bond 2

Distilled water

PLACEBO COMPARATOR

Distilled water with no desensitizing components.

Other: Distilled water

Interventions

Teethmate Desensitizer (TM) OTHER

Desensitizing agent will be applied to sensitive teeth.

Teethmate Desensitizer (TM)

Clearfil SE Bond 2 OTHER

Desensitizing agent will be applied to sensitive teeth.

Clearfil SE Bond 2 (SE)

Distilled water OTHER

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

Distilled water

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Baskent University: lead
• Hacettepe University: collaborator

Study Sites (1)

Hacettepe University

Ankara, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Dentin Sensitivity

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases

Study Officials

• Arlin Kiremitci

  Hacettepe University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: The subjects will blind to the agent being used. At each recall the investigator used blank sheets with patients' names only to avoid bias relative to previous assessments
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: For each patient, selected teeth will be randomly assigned to TM, SE or placebo by the lottery method. The subjects will blind to the agent being used. All applications will be performed by the same examiner.

Study Record Dates

• First Submitted: February 21, 2019
• First Posted: February 22, 2019
• Study Start: February 1, 2019
• Primary Completion: October 1, 2019
• Study Completion: October 1, 2019
• Last Updated: October 3, 2019

Record last verified: 2019-10

Locations

TU (1)