NCT06276777

Brief Summary

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.

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
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

First Submitted

Initial submission to the registry

February 1, 2024

Completed
25 days until next milestone

First Posted

Study publicly available on registry

February 26, 2024

Completed
2 months until next milestone

Study Start

First participant enrolled

May 1, 2024

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2024

Completed
Last Updated

February 26, 2024

Status Verified

February 1, 2024

Enrollment Period

6 months

First QC Date

February 1, 2024

Last Update Submit

February 23, 2024

Conditions

Dentin Hypersensitivity

Keywords

S-PRG

Outcome Measures

Primary Outcomes (1)

  • Dentin hypersensitivity reduction

    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.

Study Arms (2)

Varnish contains S-PRG (PRG Barrier Coat from Shofu)

EXPERIMENTAL

Treatment of dentin hypersensitivity by application of tooth varnish containing S-PRG.

Procedure: Tooth varnish (PRG Barrier Coat from Shofu)

Varnish contains sodium fluoride and functionalized tri-calcium phosphate(Clinpro white varnish 3M)

ACTIVE COMPARATOR

Treatment of dentin hypersensitivity by application of tooth varnish containing sodium fluoride with functionalized tri-calcium phosphate.

Procedure: Tooth varnish (Clinpro white varnish 3M)

Interventions

Tooth varnish (PRG Barrier Coat from Shofu)PROCEDURE

Treatment of cervical dentin hypersensitivity with tooth desensitizers.

Varnish contains S-PRG (PRG Barrier Coat from Shofu)
Tooth varnish (Clinpro white varnish 3M)PROCEDURE

Treatment of cervical dentin hypersensitivity with tooth desensitizers.

Varnish contains sodium fluoride and functionalized tri-calcium phosphate(Clinpro white varnish 3M)

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Dentistry Cairo University

Cairo, 11331, Egypt

Location

MeSH Terms

Conditions

Dentin Sensitivity

Condition Hierarchy (Ancestors)

Tooth DiseasesStomatognathic Diseases

Study Officials

  • Eman Omar, bachelor

    Cairo University faculty of oral and dental medicine

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Eman Omar El-farouk, masters

CONTACT

01156677558eman.omar@dentistry.cu.edu.eg

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
Participants and both assessors will be blind to the type of material used.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
masters degree student

Study Record Dates

First Submitted

February 1, 2024

First Posted

February 26, 2024

Study Start

May 1, 2024

Primary Completion

November 1, 2024

Study Completion

December 1, 2024

Last Updated

February 26, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)