NCT04527159

Brief Summary

To compare the efficacy of two commercially available in-office desensitizing agents (Fluoraphat Pro and VivaSens®), in the treatment of dentinal hypersensitivity.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 6, 2019

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2019

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 24, 2020

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

August 19, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 26, 2020

Completed
Last Updated

September 1, 2020

Status Verified

August 1, 2020

Enrollment Period

3 months

First QC Date

August 19, 2020

Last Update Submit

August 30, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • Likert type scale used to measure attitudes or opinions

    Likert type scale grading from 0-4 0: No sensitivity 1. Very mild sensitivity 2. Mild sensitivity 3. Moderate Sensitivity 4. Severe Sensitivity to compare the efficacy of two commercially available in-office desensitizing agents (Fluoraphat Pro and VivaSens®), in the treatment of dentinal hypersensitivity.

    24 Hours

Study Arms (1)

desensitizing agents (Fluoraphat Pro and VivaSens®)

OTHER

22 participants above the age of 18 years who presented to dental clinics in Riyadh Elm University with dentine hypersensitivity were randomly selected to participate in the study. Each participant has at least two teeth with natural hypersensitivity which was not caused by any iatrogenic causes or bad oral habits, so there are 44 cases divided into two groups according to the material used, each group has 22 teeth, that make it applicable to apply the studied material with every patient on individual tooth with the same variables of the oral mouth. When teeth in the hypersensitivity group were evaluated for the level of DH, all teeth were found to have Grade 4 sensitivity.

Drug: Fluoraphat Pro / VivaSens

Interventions

desensitizing agents for treatment of dentinal hypersensitivity

Also known as: VivaSens
desensitizing agents (Fluoraphat Pro and VivaSens®)

Eligibility Criteria

Age18 Years - 50 Years
Sexall(Gender-based eligibility)
Gender Eligibility DetailsGender and Age are not included in the calculation, since the effects could not be determined reliably
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Males and females aged between 18 and 50 years
  • Patient should have at least 2 teeth with dentinal hypersensitivity
  • Sound tooth structure
  • Willingness to participate in the study

You may not qualify if:

  • Gingival recession
  • Caries
  • Non-carious lesions (attrition, abrasion, erosion, abfraction)
  • Teeth restored with dental filling
  • Fractured or cracked tooth
  • Microleakage

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nourah Aljasser

Riyadh, 13311, Saudi Arabia

Location

MeSH Terms

Conditions

Dentin Sensitivity

Interventions

VivaSens Liner

Condition Hierarchy (Ancestors)

Tooth DiseasesStomatognathic Diseases

Study Officials

  • Roula Alboouni, Prof

    Riyadh Elm University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 19, 2020

First Posted

August 26, 2020

Study Start

January 6, 2019

Primary Completion

March 30, 2019

Study Completion

February 24, 2020

Last Updated

September 1, 2020

Record last verified: 2020-08

Locations