ClinicalTrials.gg
RecruitingNCT06154941Updated Dec 4, 2023

Clinical Evaluation of Giomer Based Varnish Versus CPP-ACP Varnish in the Management of Dentin Hypersensitivity: a Randomized Clinical Trial

An interventional study of Giomer Varnish and CPP-ACP varnish in Dentin Hypersensitivity, sponsored by Cairo University. Recruiting at 1 site in Egypt. Open to participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-12-04.

Sponsored by Cairo University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Jun 2024, 2 years 5 months ago, but the record still lists the study as recruiting.
  • Started Sep 2023; still recruiting 3 years 2 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years to 40 Years
Sex
All
01

Study summary

Dentin hypersensitivity is a drastic problem, which threaten many dental patients. According to the last published systematic review and meta analysis at 2019, the prevalence of dentin hypersensitivity is being 33.5% among the population. Moreover, it was determined that young adults with age range from 18 to 44 years exhibited high percentage (43.9%) of such problem

Read the detailed description

Several approaches to dentin hypersensitivity treatment were proposed to interfere, whether transiently or permanently, with the hydrodynamic theory. These approaches include root coverage and the use of lasers, ions, dentinal sealants, and occluding and nerve depolarization agents, chosen according to the primary cause. There are two major strategies in managing DH; the first is nerve desensitization, and the second is the physical occlusion of the patent tubule. The second approach can be carried out through a wide range of treatment modalities, including the use of proteins, salts or ions to plug the tubules. Many agents introduced are capable of sealing dentinal tubules, and can be used to reduce sensitivity. Of these agents are CPP-ACP varnish and the newly introduced giomer based varnish wilth S-PRG technology

02

Conditions studied

  • Dentin Hypersensitivity

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03

In context

Dentin Sensitivity

288 studies on the registry are indexed under Dentin Sensitivity; 46 are open to participants now.

This study's planned enrollment of 60 is close to the median of 60 across 279 interventional studies indexed under Dentin Sensitivity.

Browse Dentin Sensitivity studies →

Lead sponsor

Cairo University is the lead sponsor of 4,941 studies on the registry; 1,458 are open to participants now.

Of its 37 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 40 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

  • Participants of both genders aged 18 to 40 years with good oral hygiene, suffering from pain due to dentin in at least one tooth

Exclusion criteria

Exclusion Criteria:

  • 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(1)

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.

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
60 participants (estimated)

Study arms

  • Experimental
    Giomer based Varnish

    Procedure: Giomer Varnish

  • Active comparator
    CPP-ACP based varnish

    Procedure: CPP-ACP varnish

Interventions

  • ProcedureGiomer Varnish

    A light-cured Giomer varnish for prolonged hypersensitivity relief. Seals and protects exposed dentinal tubules to prevent pain. Ideal for patients experiencing loss of enamel, gingival recession

  • ProcedureCPP-ACP varnish

    CPP binds to oral surfaces such as teeth, dentin, oral mucosa and biofilm. CPP-ACP Varnish delivers bioavailable calcium and phosphate ions to occlude dentinal tubules treating dentin hypersensitivity

06

What researchers measure

Primary outcomes

  1. evaporative test

    using an air blast from a conventional dental unit air-water syringe for 5 seconds.

    Time frame: Immediately postoperative, after 1,3 and 6 months

  2. Thermal Test

    using anaesthetic carpule kept in the refrigerator at 4oC for at least 24 hours till it became ice then it is removed from refrigerator immediately before testing .

    Time frame: Immediately postoperative, after 1,3 and 6 months

  3. Tactile test

    using the tip of a sharp explorer (number 3) to gently scratch the exposed cervical surface in an apico-coronal direction with short strokes.

    Time frame: Immediately postoperative, after 1,3 and 6 months

07

Study locations

1 of 1 sites recruiting
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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

Started Sep 2023 (actual). Primary completion is estimated for Jun 2024, 9 months after the start.

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 9 months is above 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
Nov 24, 2023
First posted
Dec 4, 2023
StartActual
Sep 1, 2023
Primary completionEst.
Jun 2024
CompletionEst.
Aug 2024
Last update
Dec 4, 2023
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 Dec 4, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06154941
Lead sponsor
Cairo University
Responsible party
yomna sayed khallaf (lecturer at faculty of dentistry Cairo university, Cairo University) — Principal investigator
First posted
Dec 4, 2023
Start date
Sep 1, 2023
Primary completion
Jun 2024 (estimated)
Completion
Aug 2024 (estimated)
Last update
Dec 4, 2023

Study contacts

Faculty of Dentistry Cairo university
Contact
dentmail@dentistry.cu.edu.eg
010 02159535

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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