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

Comparative Evaluation of Nano Hydroxy Apatite Varnish and Potassium Nitrate Gel Versus Fluoride Varnish as Non-invasive Treatment of Dentin Hypersensitivity in Permanent Teeth With Molar Incisor Hypo-mineralization: Randomized Clinical Trial

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07056855
Enrollment
48
Registered
2025-07-09
Start date
2025-07-10
Completion date
2025-07-20
Last updated
2025-07-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dentine Hypersensitivity

Brief 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.

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.

Interventions

DRUGnano hydroxy apatite varnish Intervention (1)

Fygg's professional strength, Fygg, USA

Ultradent UltraEZ Desensitizing Gel, Ultradent Inc., USA

DRUGVarnishes, Fluorid

DentKist Charm Varnish 5% Sodium Fluoride Varnish

Sponsors

Cairo University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Masking description

The assessment of outcomes will be performed with two investigators other than the main investigator, who will not be aware of the type of the intervention carried out on the assessed child.

Eligibility

Sex/Gender
ALL
Age
6 Years to 10 Years
Healthy volunteers
Yes

Inclusion 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 informed consent. 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 hypersensitivity 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.

Design outcomes

Primary

MeasureTime frameDescription
Dentin HypersensitivityBaseline, 15 miutes pot-op, 2 weeks post-op, and 4 weeks post opFace scale: scores from 0-4. the higher the score the worse the sensitivity

Secondary

MeasureTime frameDescription
Oral hygienebaseline, 2-, and 4- week post-opMeasured by Plaque Control Record: Percentage.

Contacts

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026