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NCT Number: NCT06896565

Effect of Nano Hydroxy Apatite Varnish and Potassium Nitrate Gel on the MIH-affected Permanent Teeth

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 MIH-affected teeth.

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Key information

About this study

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, and gingival health, oral health-related quality of life, preventing post-eruptive enamel breakdown, and dental caries, along with economic evaluation.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

The research unit of this study will be the MIH-affected permanent tooth, in children aged from six to ten years, from either gender.

Inclusion criteria

Participants related criteria:

  • Children aged from six to ten years old.
  • Medically free children according to the history taken from their parents.
  • Children who are categorized as Class I or II according to the American Society of Anaesthesiologists (ASA).
  • Children whom their parents accept to comply with the follow-up visits.
  • Children who accept, and their guardians, to participate in the study by signing the informed consent.
  • Children with no more than four cavitated primary teeth.

Tooth related criteria:

  • 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.
  • MIH-affected permanent teeth, suffering from dentin hypersensitivity, (MIH-TNI 3, 4a).
  • Positive Schiff Cold Airblasting Sensitivity score (score 1, 2, or 3).
  • Exclusion criteria:

Participants related criteria:

  • Children with severe behavioral or emotional disabilities.
  • Children who received analgesics within the last 24 hours before the procedure.15
  • Patients who are using chlorhexidine-based gels or mouthwashes.

Tooth related criteria:

  • A tooth with signs and symptoms of irreversible pulpitis.
  • A tooth with signs and symptoms of necrotic pulp.
  • Sealing therapy or application of desensitizing agent on the MIH teeth within one month before participation in the study.
  • Presence of dental caries on the MIH-affected permanent tooth.
  • Presence of restoration(s) on MIH-affected permanent tooth.

Treatment and study plan

nano hydroxy apatite varnish

Drug

Intervention (1)

Other names: Fygg's professional strength, Fygg, USA

Potassium Nitrate Gel

Drug

Intervention (2)

Other names: Ultradent UltraEZ Desensitizing Gel, Ultradent Inc., USA

Varnishes, Fluoride

Drug

Control

Other names: DentKist Charm Varnish 5% Sodium Fluoride Varnish

Primary outcomes

  1. Dentin Hypersensitivity

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

    Measured by:

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

  2. Dentin Hypersensitivity

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

    Measured by:

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

Secondary outcomes

  1. Post-eruptive enamel breakdown

    Time frame: : baseline, 3-, 6-, 9-, and 12- month post-op.

    Measured by Wurzburg Molar Incisor Hypomineralization - Treatment Need Index (MIH-TNI): ordinal scores: 1,2,3, 4a, 4b, 4c.

  2. Caries incidence

    Time frame: baseline, 3-, 6-, 9-, and 12- month post-op.

    Measured by International Caries Detection and Assessment System (ICDAS II) criteria: scores from 0-6.

    The higher the score the worse the caries.

  3. Oral hygiene

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

    Measured by Plaque Control Record: Percentage.

  4. Oral health-related quality of life

    Time frame: baseline, 6-, and 12- month post-op.

    Measured by: Short form Parental-Caregiver Perceptions Questionnaire (P-CPQ): from 0 -32.

    The higher the score the worse the Oral Health Related Quality of Life.

  5. Cost Effectiveness Ratio (CER) and Incremental Cost Effectiveness Ratio (ICER

    Time frame: 12-month- post-op.

    Measured by: Equation : CER = C / E, where C is the average direct medical cost calculated for the group, and E is the health effectiveness measure for the same group (change in hypersensitivity score).

    ICER = (CI - CC) / (EI - EC), where CI is the average direct medical cost of the intervention group CC is the average direct medical cost in the control group, EI is the health effectiveness measure (change in hypersensitivity score) in the intervention group, and EC is the health effectiveness measure in the control group

Study contacts

Contact information is provided by the study sponsor or research team.

Mennat Allah AA Abd Elsabour, PhD student

CONTACT

[email protected]

+201026022605

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

Comparative Evaluation of Three Different Topically Applied Materials as Non-invasive Treatment of Permanent Teeth With Molar Incisor Hypo-mineralization: Randomized Clinical Trial

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Mar 26, 2025
Registry last updated
Apr 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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