ClinicalTrials.gg
Sign In
Not yet recruitingNCT07056855Updated Jul 9, 2025

Three Different Topically Applied Materials as Non-invasive Treatment of Sensitivity in Permanent Teeth With Molar Incisor Hypomineralization

An interventional study of nano hydroxy apatite varnish Intervention (1) and Potassium Nitrate Gel in Dentine Hypersensitivity, sponsored by Cairo University. Not yet recruiting. Open to participants aged 6 Years to 10 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-07-09.

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

From the registry’s dates

  • Primary completion was expected by Jul 2025, 1 year 3 months ago, but the record still lists the study as not yet recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
48
Allocation
Randomized
Ages
6 Years to 10 Years
Sex
All
01

Study summary

This clinical study main goal is to investigate the effectiveness of nano hydroxy apatite crystal varnish and potassium nitrate gel as a non invasive approach in managing Dentin Hypersensitivity in MIH-affected teeth.

Read the detailed description

This randomized clinical trial study aims to investigate the effectiveness of nano-hydroxy apatite crystal varnish, and potassium nitrate gel compared to fluoride varnish, in reducing dentin hypersensitivity, improving a child's oral hygiene.

02

Conditions studied

  • Dentine Hypersensitivity

Browse trials for

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 48 is below 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.

Browse Cairo University studies →

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

04

Who can participate

Ages eligible
6 Years to 10 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Eligibility criteria

Participants related criteria:

  1. Children aged from six to ten years old.
  2. Medically free children according to the history taken from their parents.
  3. Children who are categorized as Class I or II according to the American Society of Anaesthesiologists (ASA).
  4. Children whom their parents accept to comply with the follow-up visits.
  5. Children who accept, and their guardians, to participate in the study by signing the .

Tooth related criteria:

1. The diagnosis of MIH will be done as per the Wurzburg concept, 2023 MIH diagnostic criteria: The child will be confirmed to have MIH if any of the following characteristics are apparent:

  • affected teeth show a clearly defined opacity at the occlusal and buccal surfaces of a tooth,
  • defects vary in shape, size, and pattern,
  • white, cream-colored, or yellow-brown color deviations are recognizable,
  • defects variably vary in size,
  • teeth with are present,
  • teeth have an atypical restoration,
  • permanent teeth for (suspected) MIH reasons are missing (extractions),

  • combinations of the above characteristics are present.

    1. MIH-affected permanent teeth, suffering from dentin hypersensitivity, (MIH-TNI 3).
    2. Positive Schiff Cold Airblasting Sensitivity score (score 1, 2, or 3).
  • Exclusion criteria:

Participants related criteria:

  1. Children with severe behavioral or emotional disabilities.
  2. Children who received analgesics within the last 24 hours before the procedure.
  3. Patients who are using chlorhexidine-based gels or mouthwashes.

Tooth related criteria:

  1. A tooth with signs and symptoms of irreversible pulpitis.
  2. A tooth with signs and symptoms of necrotic pulp.
  3. Sealing therapy or application of desensitizing agent on the MIH teeth within one month before participation in the study.
  4. Presence of dental caries on the MIH-affected permanent tooth.
  5. Presence of restoration(s) on MIH-affected permanent tooth.
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
Single (Outcomes assessor)
Enrollment
48 participants (estimated)

Study arms

  • Experimental
    8.6% nano-hydroxy apatite crystals varnish (Fygg's professional strength, Fygg, USA).

    Intervention group (1)

    Drug: nano hydroxy apatite varnish Intervention (1)

  • Experimental
    Potassium Nitrate (Ultradent UltraEZ Desensitizing Gel, Ultradent Inc., USA).

    Intervention group (2)

    Drug: Potassium Nitrate Gel

  • Active comparator
    5% fluoride varnish Control group

    Drug: Varnishes, Fluorid

Interventions

  • Drugnano hydroxy apatite varnish Intervention (1)

    Fygg's professional strength, Fygg, USA

  • DrugPotassium Nitrate Gel

    Ultradent UltraEZ Desensitizing Gel, Ultradent Inc., USA

  • DrugVarnishes, Fluorid

    DentKist Charm Varnish 5% Sodium Fluoride Varnish

06

What researchers measure

Primary outcomes

  1. Dentin Hypersensitivity

    Face scale: scores from 0-4. the higher the score the worse the sensitivity

    Time frame: Baseline, 15 miutes pot-op, 2 weeks post-op, and 4 weeks post op

  2. Dentin Hypersensitivity

    chiff Cold Air Blasting Sensitivity Scale: scores from 0-3. The higher the score the worse the sensitivity.

    Time frame: Baseline, 15 miutes pot-op, 2 weeks post-op, and 4 weeks post op

Secondary outcomes

  1. Oral hygiene

    Measured by Plaque Control Record: Percentage.

    Time frame: baseline, 2-, and 4- week post-op

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: Undecided

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 Jul 2025; primary completion for Jul 2025, 0 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 0 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
Jun 29, 2025
First posted
Jul 9, 2025
StartEst.
Jul 10, 2025
Primary completionEst.
Jul 20, 2025
CompletionEst.
Jul 20, 2025
Last update
Jul 9, 2025
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 Jul 9, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07056855
Lead sponsor
Cairo University
Responsible party
Mennat Allah Ashraf Abd Elsabour Abd Elkareem (Assistant Lecturer, Pediatric Dentistry Department, Ahram Canadian University. PhD student, Pediatric Dentistry and Dental Public Health Department, Cairo University. Affiliation: Cairo University, Cairo University) — Principal investigator
First posted
Jul 9, 2025
Start date
Jul 10, 2025 (estimated)
Primary completion
Jul 20, 2025 (estimated)
Completion
Jul 20, 2025 (estimated)
Last update
Jul 9, 2025

Study contacts

Mennat Allah A. A. Abd Elsabour, PhD student
Contact
mennatallah.ashraf@dentistry.cu.edu.eg
+201026022605

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 Mar 2025. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Studies of the drug tested here: Potassium nitrate

Other studies in this condition

Dentin Sensitivity →

Other studies from this sponsor

Cairo University →

Start the discussion