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

NCT ID: NCT06896565

Last Updated: 2025-04-24

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-06-01
• Study Completion Date: 2026-08-01

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.

Conditions

Molar Incisor Hypomineralisation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Potassium Nitrate gel

Intervention group (2)

Group Type: EXPERIMENTAL

Potassium Nitrate Gel

Intervention Type: DRUG

Intervention (2)

5% fluoride varnish

Control group

Group Type: ACTIVE_COMPARATOR

Varnishes, Fluoride

Intervention Type: DRUG

Control

8.6% nano-hydroxy apatite crystals varnish.

Intervention group (1)

Group Type: EXPERIMENTAL

nano hydroxy apatite varnish

Intervention Type: DRUG

Intervention (1)

Interventions

nano hydroxy apatite varnish

Intervention (1)

Intervention Type: DRUG

Potassium Nitrate Gel

Intervention (2)

Intervention Type: DRUG

Varnishes, Fluoride

Control

Intervention Type: DRUG

Other Intervention Names

Fygg's professional strength, Fygg, USA; Ultradent UltraEZ Desensitizing Gel, Ultradent Inc., USA; DentKist Charm Varnish 5% Sodium Fluoride Varnish

Eligibility Criteria

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.

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 10 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Mennat Allah Ashraf Abd Elsabour Abd Elkareem

Assistant Lecturer, Pediatric Dentistry Department, Ahram Canadian University. PhD student, Pediatric Dentistry and Dental Public Health Department, Cairo University.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Mennat Allah AA Abd Elsabour, PhD student

Role: CONTACT

mennatallah.ashraf@dentistry.cu.edu.eg

+201026022605

Other Identifiers

22222

Identifier Type: -

Identifier Source: org_study_id