NCT03818945

Brief Summary

to solve the problem of hypersensitivity, I will use two different materials ( Giomer versus Sodium Fluoride) and compare between their effects in reliving the symptoms

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
104

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Mar 2019

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 24, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 28, 2019

Completed
1 month until next milestone

Study Start

First participant enrolled

March 1, 2019

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2019

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2019

Completed
Last Updated

January 28, 2019

Status Verified

January 1, 2019

Enrollment Period

3 months

First QC Date

January 24, 2019

Last Update Submit

January 25, 2019

Conditions

Tooth Hypersensitivity

Outcome Measures

Primary Outcomes (1)

  • relieving of hypersensitivity

    The sensitive teeth will be assessed by two stimuli: tactile and thermal stimuli than scored according to the visual analog scale from zero to ten.

    one month

Study Arms (2)

Sodium Fluoride Varnish

OTHER
Drug: Sodium fluoride varnish

PRG barrier Giomer

ACTIVE COMPARATOR
Drug: shofu PRG barrier coat

Interventions

shofu PRG barrier coatDRUG

Trilaminar structure which forms a type of stable glass ionomer allowing ion release and recharge, while protecting the glass core from the damaging effects of moisture, greatly improving long-term durability.(Na, BO3, Al, SiO3, F,Sr)

Also known as: Light cured giomer
PRG barrier Giomer
Sodium fluoride varnishDRUG

5% sodium fluoride \[22,600 ppm F-\]

Also known as: Biofluoride 5% Fluoride varnish single use dose - Vocoo
Sodium Fluoride Varnish

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Patients aged from 18 to 40 years.
  • No gender restriction.
  • Patients should have pain score in the visual analog scale two or more.
  • Patients must have at least one sensitive tooth in one of four quadrants.

You may not qualify if:

  • Patients with active carious lesions.
  • Needing restorative treatment.
  • Receiving periodontal treatment.
  • Taking desensitizing treatment in the last 6 months.
  • Taking anti-inflammatory drugs.
  • Pregnant patients.
  • Smokers.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Dentistry

Giza, Egypt

RECRUITING

MeSH Terms

Conditions

Dentin Sensitivity

Interventions

Bifluorid 12

Condition Hierarchy (Ancestors)

Tooth DiseasesStomatognathic Diseases

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator in Cairo university

Study Record Dates

First Submitted

January 24, 2019

First Posted

January 28, 2019

Study Start

March 1, 2019

Primary Completion

June 1, 2019

Study Completion

September 1, 2019

Last Updated

January 28, 2019

Record last verified: 2019-01

Locations

EG(1)