Status:
NOT_YET_RECRUITING
Effect of Nano Hydroxy Apatite Varnish and Potassium Nitrate Gel on the MIH-affected Permanent Teeth
Lead Sponsor:
Cairo University
Conditions:
Molar Incisor Hypomineralisation
Eligibility:
All Genders
6-10 years
Phase:
NA
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 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 hypersens...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
June 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2026
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT06896565
Start Date
June 1 2025
End Date
August 1 2026
Last Update
April 24 2025
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