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Search / Trial NCT06896565

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

Launched by CAIRO UNIVERSITY · Mar 24, 2025

Trial Information

Current as of July 01, 2025

Not yet recruiting

Keywords

ClinConnect Summary

This clinical trial is looking at two treatments, nano hydroxy apatite varnish and potassium nitrate gel, to help manage Molar Incisor Hypomineralisation (MIH) in children. MIH is a condition that affects the enamel of permanent teeth, making them more sensitive and prone to discoloration. The goal of the study is to see if these treatments can help improve the condition of MIH-affected teeth without needing more invasive procedures.

To participate in this trial, children must be between six to ten years old and must have been diagnosed with MIH. They should be generally healthy, with no serious medical issues, and their parents must agree to follow up after treatment. Participants will receive the treatments and have regular check-ups to monitor their teeth's response. It’s important to note that children with certain dental issues or who have recently used specific dental treatments will not be eligible for this study. Overall, this trial aims to find a safer and less invasive way to help children with MIH.

Gender

ALL

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:
  • 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.
  • 6. 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.
  • 1. MIH-affected permanent teeth, suffering from dentin hypersensitivity, (MIH-TNI 3, 4a).
  • 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.15
  • 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.

About Cairo University

Cairo University, a premier institution in Egypt, is dedicated to advancing medical research and education through innovative clinical trials. With a strong emphasis on improving healthcare outcomes, the university collaborates with various stakeholders to conduct rigorous scientific studies that address critical health challenges. Leveraging its extensive resources and expert faculty, Cairo University aims to contribute valuable insights to the medical community and enhance patient care both locally and globally. Through its commitment to ethical research practices and excellence, the university plays a pivotal role in shaping the future of healthcare in the region.

Locations

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Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported