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

N/ANot Yet RecruitingNCT06896565

Cairo University48 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Molar Incisor Hypomineralisation

Interventions

nano hydroxy apatite varnishDRUG

Intervention (1)

Potassium Nitrate GelDRUG

Intervention (2)

Varnishes, FluorideDRUG

Control

Eligibility

Sex: ALLMin age: 6 YearsMax age: 10 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Dentin Hypersensitivity

Measured by: Face scale: scores from 0-4. the higher the score the worse the sensitivity.

Time frame: 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.

Time frame: Baseline, 15 miutes pot-op, 2 weeks post-op, and 4 weeks post op.

Secondary Outcomes

Post-eruptive enamel breakdown

Measured by Wurzburg Molar Incisor Hypomineralization - Treatment Need Index (MIH-TNI): ordinal scores: 1,2,3, 4a, 4b, 4c.

Time frame: : baseline, 3-, 6-, 9-, and 12- month 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.

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

Oral hygiene

Measured by Plaque Control Record: Percentage.

Time frame: baseline, 2-, and 4- week 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.

Time frame: 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

Central Contacts

Mennat Allah AA Abd Elsabour, PhD student

CONTACT

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

Data from ClinicalTrials.gov

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