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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Molar Incisor Hypomineralisation
• Intervention / Treatment: Drug: nano hydroxy apatite varnish; Drug: Potassium Nitrate Gel; Drug: Varnishes, Fluoride

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 Type: Interventional
• Enrollment (Estimated): 48
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mennat Allah AA Abd Elsabour, PhD student; Phone Number: +201026022605; Email: mennatallah.ashraf@dentistry.cu.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 8.6% nano-hydroxy apatite crystals varnish.; Intervention group (1)	Drug: nano hydroxy apatite varnish; Intervention (1); Other Names: Fygg's professional strength, Fygg, USA
Experimental: Potassium Nitrate gel; Intervention group (2)	Drug: Potassium Nitrate Gel; Intervention (2); Other Names: Ultradent UltraEZ Desensitizing Gel, Ultradent Inc., USA
Active Comparator: 5% fluoride varnish; Control group	Drug: Varnishes, Fluoride; Control; Other Names: DentKist Charm Varnish 5% Sodium Fluoride Varnish

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dentin Hypersensitivity	Measured by: Face scale: scores from 0-4. the higher the score the worse the sensitivity.	Baseline, 15 miutes pot-op, 2 weeks post-op, and 4 weeks post op.
Dentin Hypersensitivity	Measured by: Schiff Cold Air Blasting Sensitivity Scale: scores from 0-3. The higher the score the worse the sensitivity.	Baseline, 15 miutes pot-op, 2 weeks post-op, and 4 weeks post op.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Post-eruptive enamel breakdown	Measured by Wurzburg Molar Incisor Hypomineralization - Treatment Need Index (MIH-TNI): ordinal scores: 1,2,3, 4a, 4b, 4c.	: baseline, 3-, 6-, 9-, and 12- month post-op.
Oral hygiene	Measured by Plaque Control Record: Percentage.	baseline, 2-, and 4- week post-op.
Caries incidence	Measured by International Caries Detection and Assessment System (ICDAS II) criteria: scores from 0-6. The higher the score the worse the caries.	baseline, 3-, 6-, 9-, and 12- month post-op.
Oral health-related quality of life	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.	baseline, 6-, and 12- month post-op.
Cost Effectiveness Ratio (CER) and Incremental Cost Effectiveness Ratio (ICER	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	12-month- post-op.

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2025
• Primary Completion (Estimated): August 20, 2025
• Study Completion (Estimated): August 1, 2026

Study Registration Dates

• First Submitted: March 19, 2025
• First Submitted That Met QC Criteria: March 24, 2025
• First Posted (Actual): March 26, 2025

Study Record Updates

• Last Update Posted (Actual): April 24, 2025
• Last Update Submitted That Met QC Criteria: April 22, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Dental Enamel Hypomineralization; Developmental Defects of Enamel; Stomatognathic Diseases; Tooth Diseases; Stomatognathic System Abnormalities; Congenital Abnormalities; Tooth Abnormalities; Molar Hypomineralization; Physiological Effects of Drugs; Protective Agents; Cariostatic Agents; Fluorides; Sodium Fluoride; Fluorides, Topical
• Other Study ID Numbers: 22222

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No