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Not yet recruitingNCT06276777S-PRGUpdated Feb 26, 2024

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

An interventional study of Tooth varnish (PRG Barrier Coat from Shofu) and Tooth varnish (Clinpro white varnish 3M) in Dentin Hypersensitivity, sponsored by Eman Omar Elfarouk. Not yet recruiting at 1 site in Egypt. Open to participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-02-26.

Sponsored by Eman Omar Elfarouk · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Nov 2024, 2 years ago, but the record still lists the study as not yet recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Randomized
Ages
18 Years to 50 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 33 studies in Dentin Sensitivity with a site in Egypt — 6 open to participants now, 8 under way, 1 of them phase 3. Dentin Sensitivity · Egypt.

Planned enrollment
13th of 32
50 · median 48
Started
2024
with 7 others
No phase
24 of 33
5 open now
Registered
16th of 33
by date
Lead sponsor
1 of 33
Eman Omar Elfarouk

Among the 33 studies in Dentin Sensitivity with a site in Egypt, this one is the 13th largest by planned enrollment of the 32 interventional ones, is one of 8 that started in 2024, is one of 24 with no phase, and was the 16th registered.

By phase

33 studies; the count open now beside each. This study's row is marked.

No phasethis study24 · 5 open
Phase 45 · 0 open
Phase 12 · 0 open
Observational1 · 1 open
Phase 2/31 · 0 open

By the year they started

First in 2017; this study’s year is marked. 8 started in 2024.

What they test

Size and results

Median enrollment 48 across the 32 interventional studies, 500 across the 1 observational. Of the 20 that completed or were terminated, 0 (0%) have results posted.

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Watch this landscapeDownload CSVWith an account: a weekly mail of what changed among 33 studies in Dentin Sensitivity with a site in Egypt, or all of them as a file.
02

Study 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.

03

Conditions studied

  • Dentin Hypersensitivity

Browse trials for

Keywords

  • S-PRG
04

Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Good oral hygiene.
  • Cooperative patients who show interest to participate in the study and welling to sign the .
  • 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

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 perception).
  • Pregnant females (They complain from nausea and repeated vomiting attacks)
  • Smokers (Smoking will affect the oral hygiene and periodontal health).
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
50 participants (estimated)

Study arms

  • 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)

  • 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)

Interventions

  • ProcedureTooth varnish (PRG Barrier Coat from Shofu)

    Treatment of cervical dentin hypersensitivity with tooth desensitizers.

  • ProcedureTooth varnish (Clinpro white varnish 3M)

    Treatment of cervical dentin hypersensitivity with tooth desensitizers.

06

What researchers measure

Primary outcomes

  1. Dentin hypersensitivity reduction

    The participants will point out the degree of sensitivity on the VAS scale (0-10) chart.

    Time frame: assessment will be done immediately after the treatment then after 1 week, 4 weeks, 3 months and 6 months.

07

Study locations

1 site
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for May 2024; primary completion for Nov 2024, 6 months later.

Of 111 non-industry interventional studies with no phase under Dentin Sensitivity, half reached primary completion within 7 months of starting (the median), counting those still running; a quarter within 4 and three quarters within 12. This study's planned 6 months is below that.

Counting every sponsor, half of 144 studies reached it within 6 months; a quarter within 3 and three quarters within 10.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 1, 2024
First posted
Feb 26, 2024
StartEst.
May 1, 2024
Primary completionEst.
Nov 1, 2024
CompletionEst.
Dec 1, 2024
Last update
Feb 26, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 26, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06276777
Lead sponsor
Eman Omar Elfarouk
Responsible party
Eman Omar Elfarouk (masters degree student, Cairo University) — Sponsor-investigator
First posted
Feb 26, 2024
Start date
May 1, 2024 (estimated)
Primary completion
Nov 1, 2024 (estimated)
Completion
Dec 1, 2024 (estimated)
Last update
Feb 26, 2024

Study contacts

Eman Omar El-farouk, masters
Contact
eman.omar@dentistry.cu.edu.eg
01156677558
Eman Omar, bachelor
principal investigator · Cairo University faculty of oral and dental medicine

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Feb 2024. You cannot join it, but the record below documents what was studied.

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Discussion

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