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

NCT06896565 | Not Yet Recruiting DMC

• 1 other identifier: 22222
• Study Type: interventional
• Target: 48
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Molar Incisor Hypomineralisation

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• Post-eruptive enamel breakdown

  : baseline, 3-, 6-, 9-, and 12- month post-op.

• Caries incidence

  baseline, 3-, 6-, 9-, and 12- month post-op.

• Oral hygiene

  baseline, 2-, and 4- week post-op.

• Oral health-related quality of life

  baseline, 6-, and 12- month post-op.

• Cost Effectiveness Ratio (CER) and Incremental Cost Effectiveness Ratio (ICER

  12-month- post-op.

Study Arms (3)

8.6% nano-hydroxy apatite crystals varnish.

EXPERIMENTAL

Intervention group (1)

Drug: nano hydroxy apatite varnish

Potassium Nitrate gel

EXPERIMENTAL

Intervention group (2)

Drug: Potassium Nitrate Gel

5% fluoride varnish

ACTIVE COMPARATOR

Control group

Drug: Varnishes, Fluoride

Interventions

nano hydroxy apatite varnish DRUG

Intervention (1)

Also known as: Fygg's professional strength, Fygg, USA

8.6% nano-hydroxy apatite crystals varnish.

Potassium Nitrate Gel DRUG

Intervention (2)

Also known as: Ultradent UltraEZ Desensitizing Gel, Ultradent Inc., USA

Potassium Nitrate gel

Varnishes, Fluoride DRUG

Control

Also known as: DentKist Charm Varnish 5% Sodium Fluoride Varnish

5% fluoride varnish

Eligibility Criteria

• Age: 6 Years - 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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:
• \. 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,

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

MeSH Terms

Conditions

Molar Hypomineralization

Interventions

Fluorides, Topical

Condition Hierarchy (Ancestors)

Dental Enamel Hypomineralization; Developmental Defects of Enamel; Tooth Abnormalities; Stomatognathic System Abnormalities; Stomatognathic Diseases; Tooth Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Fluorides; Hydrofluoric Acid; Fluorine Compounds; Inorganic Chemicals; Cariostatic Agents; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture

Central Study Contacts

Mennat Allah AA Abd Elsabour, PhD student

CONTACT

+201026022605; mennatallah.ashraf@dentistry.cu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: the assessment of outcomes will be performed with two investigators other than the main investigator, who will not be aware of the type of the intervention carried out on the assessed child.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Lecturer, Pediatric Dentistry Department, Ahram Canadian University. PhD student, Pediatric Dentistry and Dental Public Health Department, Cairo University.

Study Record Dates

• First Submitted: March 19, 2025
• First Posted: March 26, 2025
• Study Start: June 1, 2025
• Primary Completion: August 20, 2025
• Study Completion (Estimated): August 1, 2026
• Last Updated: April 24, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share