The Effect of Using Desensitizers Containing S-PRG In Treatment Of Dentin Hypersensitivity Over 6 Months: A Randomized Clinical Trial (S-PRG)

February 23, 2024 updated by: Eman Omar Elfarouk

The Effect of Using Desensitizers Containing S-PRG Versus Sodium Fluoride With Functionalized Tri-Calcium Phosphate In Treatment Of Dentin Hypersensitivity In Adult Patients Over 6 Months: A Randomized Clinical Trial

The goal of this clinical trial is to compare the effect of desensitizer containing S-PRG have similar effect as sodium fluoride with functionalized tri-calcium phosphate containing desensitizer in relieving dentinal hypersensitivity in adult patients for six months follow-up. patients will be asked to report pain degree on the visual analogue scale (VAS) along the follow up periods on both groups.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Good oral hygiene.
  • Cooperative patients who show interest to participate in the study and welling to sign the informed consent.
  • Healthy patients with no history of previous systematic diseases that can affect their oral health.
  • Normal and healthy gingival tissue.
  • Teeth that have no cavitation or restorations.
  • Patients with at least 20 natural permanent teeth and at least two teeth with a VAS score from 4 to 10.
  • Anterior teeth.

Exclusion Criteria:

  • Allergic to the ingredients used in the study.
  • Gastrointestinal disorders (They have repeated vomiting attacks).
  • Medically compromised (They cannot tolerate the procedures).
  • Taking desensitizing treatment in the last 6 months (It affects the outcome).
  • Taking anti-inflammatory drugs (It affects the hypersensitivity perception).
  • Pregnant females (They complain from nausea and repeated vomiting attacks)
  • Smokers (Smoking will affect the oral hygiene and periodontal health).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Varnish contains S-PRG (PRG Barrier Coat from Shofu)
Treatment of dentin hypersensitivity by application of tooth varnish containing S-PRG.
Procedure: Tooth varnish (PRG Barrier Coat from Shofu)
Treatment of cervical dentin hypersensitivity with tooth desensitizers.
Active Comparator: Varnish contains sodium fluoride and functionalized tri-calcium phosphate(Clinpro white varnish 3M)
Treatment of dentin hypersensitivity by application of tooth varnish containing sodium fluoride with functionalized tri-calcium phosphate.
Procedure: Tooth varnish (Clinpro white varnish 3M)
Treatment of cervical dentin hypersensitivity with tooth desensitizers.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Dentin hypersensitivity reduction
Time Frame: assessment will be done immediately after the treatment then after 1 week, 4 weeks, 3 months and 6 months.
The participants will point out the degree of sensitivity on the VAS scale (0-10) chart.
assessment will be done immediately after the treatment then after 1 week, 4 weeks, 3 months and 6 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eman Omar Elfarouk

Investigators

  • Principal Investigator: Eman Omar, bachelor, Cairo University faculty of oral and dental medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 1, 2024

Primary Completion (Estimated)

November 1, 2024

Study Completion (Estimated)

December 1, 2024

Study Registration Dates

First Submitted

February 1, 2024

First Submitted That Met QC Criteria

February 23, 2024

First Posted (Actual)

February 26, 2024

Study Record Updates

Last Update Posted (Actual)

February 26, 2024

Last Update Submitted That Met QC Criteria

February 23, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SPRG Dentin Hypersensitivity

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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