Menu
Not yet recruiting NCT06896565

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

No phase Interventional Molar Incisor Hypomineralisation

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: nano hydroxy apatite varnish, Potassium Nitrate Gel, Varnishes, Fluoride.
Who it may be relevant to
Registry conditions: Molar Incisor Hypomineralisation. Basic parameters: 6 years — 10 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

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

Interventions

  • Drug nano hydroxy apatite varnish
    Intervention (1)
  • Drug Potassium Nitrate Gel
    Intervention (2)
  • Drug Varnishes, Fluoride
    Control

Primary outcome measures

  • Dentin Hypersensitivity [Time frame: Baseline, 15 miutes pot-op, 2 weeks post-op, and 4 weeks post op.]
  • Dentin Hypersensitivity [Time frame: Baseline, 15 miutes pot-op, 2 weeks post-op, and 4 weeks post op.]
Secondary outcome measures (5)
  • Post-eruptive enamel breakdown [Time frame: : baseline, 3-, 6-, 9-, and 12- month post-op.]
  • Caries incidence [Time frame: baseline, 3-, 6-, 9-, and 12- month post-op.]
  • Oral hygiene [Time frame: baseline, 2-, and 4- week post-op.]
  • Oral health-related quality of life [Time frame: baseline, 6-, and 12- month post-op.]
  • Cost Effectiveness Ratio (CER) and Incremental Cost Effectiveness Ratio (ICER [Time frame: 12-month- post-op.]

Eligibility criteria

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:

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.
  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06896565 · 22222

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗