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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-07-10

Study Completion Date

2025-07-20

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Dentine Hypersensitivity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

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.

Study Groups

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

Intervention group (1)

Group Type EXPERIMENTAL

nano hydroxy apatite varnish Intervention (1)

Intervention Type DRUG

Fygg's professional strength, Fygg, USA

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

Intervention group (2)

Group Type EXPERIMENTAL

Potassium Nitrate Gel

Intervention Type DRUG

Ultradent UltraEZ Desensitizing Gel, Ultradent Inc., USA

5% fluoride varnish Control group

Group Type ACTIVE_COMPARATOR

Varnishes, Fluorid

Intervention Type DRUG

DentKist Charm Varnish 5% Sodium Fluoride Varnish

Interventions

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nano hydroxy apatite varnish Intervention (1)

Fygg's professional strength, Fygg, USA

Intervention Type DRUG

Potassium Nitrate Gel

Ultradent UltraEZ Desensitizing Gel, Ultradent Inc., USA

Intervention Type DRUG

Varnishes, Fluorid

DentKist Charm Varnish 5% Sodium Fluoride Varnish

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

6 Years

Maximum Eligible Age

10 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Responsible Party

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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

Responsibility Role PRINCIPAL_INVESTIGATOR