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

Not Applicable

Not yet recruiting

• Conditions: Molar Incisor Hypomineralisation
• Interventions: Drug: nano hydroxy apatite varnish; Drug: Potassium Nitrate Gel; Drug: Varnishes, Fluoride

• Registration Number: NCT06896565
• Lead Sponsor: Cairo University

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 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.

Study Timeline

• Study First Submitted: 2025-03-19
• Study First Submitted QC: 2025-03-24
• Study First Posted: 2025-03-26
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-22
• Last Update Posted: 2025-04-24
• Study Start: 2025-06-01
• Primary Completion: 2025-08-20
• Study Completion: 2026-08-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 48

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
8.6% nano-hydroxy apatite crystals varnish.	nano hydroxy apatite varnish	Intervention group (1)
Potassium Nitrate gel	Potassium Nitrate Gel	Intervention group (2)
5% fluoride varnish	Varnishes, Fluoride	Control group

Primary Outcome Measures

Name	Time	Method
Dentin Hypersensitivity	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 Outcome Measures

Name	Time	Method
Post-eruptive enamel breakdown	: 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.
Caries incidence	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.
Oral hygiene	baseline, 2-, and 4- week post-op.	Measured by Plaque Control Record: Percentage.
Oral health-related quality of life	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.
Cost Effectiveness Ratio (CER) and Incremental Cost Effectiveness Ratio (ICER	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