Color Change and Desensitization of Molar Incisor Hypomineralization-Affected Enamel Using Biomimetic Nano-Hydroxyapatite Toothpaste

ConditionMolar-Incisor Hypomineralization (MIH)

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age6-12

SponsorKing Abdulaziz University

About this trial

This clinical trial aims to evaluate if nano-hydroxyapatite (Nano-HA) toothpaste effectively treats children with Molar-Incisor Hypomineralization (MIH). It will also assess the safety of Nano-HA toothpaste. The main questions are:

* Does Nano-HA toothpaste reduce caries incidence, improve tooth aesthetics, and decrease hypersensitivity? * How does Nano-HA compare to fluoridated toothpaste in terms of outcomes?

Participants will:

* Use Nano-HA or fluoridated toothpaste daily for 12 months. * Visit the clinic for checkups and evaluations every 1 to 3 months. * Record symptoms, brushing compliance, and sensitivity.

The study will compare Nano-HA toothpaste to fluoridated toothpaste to determine its efficacy in managing MIH .

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Diagnosed with Molar-Incisor Hypomineralization (MIH) in at least one first permanent molar or hypomineralization of a second primary molar (HSPM).

Presence of white, creamy, yellow, or brown demarcated opacities

Indexed teeth include permanent first molars and permanent maxillary incisors.

Disqualifiers

• Decayed permanent molars.

Diabetes, hypertension, sleeping disorders, or allergic reactions to medications.

Children on medication

Presence of other enamel defects (e.g., fluorosis, amelogenesis imperfecta, enamel hypoplasia, or white spot lesions).

Trial design

Design model

Parallel

Treatments tested in this trial

Fluoridated Toothpaste
Device
Participants will use fluoridated toothpaste (1450 ppm fluoride) three times daily under parental supervision for 9 months to compare its effects with Nano-hydroxyapatite.
Nano-hydroxyapatite Toothpaste
Device
Participants in this group will brush their teeth with Nano-hydroxyapatite toothpaste three times daily under parental supervision for 9 months to evaluate its impact on caries reduction, aesthetics, and sensitivity.

Treatment groups

60 Participants

are divided into 2 treatment groups

Group A: Nano-hydroxyapatite Toothpaste GroupExperimental treatment 1 intervention

Group B: Fluoridated Toothpaste GroupActive comparator 1 intervention

Trial outcomes

Primary outcomes

Desensitization of Molar Incisor Hypomineralization-Affected Enamel Using Biomimetic Nano-Hydroxyapatite Toothpaste

Hypersensitivity can be measured using the Schiff sensitivity scale to rate patients' pain The Schiff Cold Air Sensitivity Scale is a 4-point scale used to assess dentin hypersensitivity. A score of zero indicates no sensitivity, one signifies mild sensitivity without a request to stop the stimulus, two represents moderate sensitivity with a request to stop or visible discomfort, and three indicates severe sensitivity with a request to stop and physical withdrawal.

Time frame

Follow-up duration: 12 months. Clinical evaluations will be conducted at baseline (T0), 1 month (T1), 3 months (T2), 6 months (T3), 9 months (T4), and 12 months (T5). The primary endpoint will be assessed at 6 months to evaluate treatment effectiveness

Secondary outcomes

Color Change of Molar Incisor Hypomineralization-Affected Enamel Using Biomimetic Nano-Hydroxyapatite Toothpaste

The VITA Easyshade® advance spectrophotometer (VITA Zahnfabrik, Bad Sackingen, Germany) will be used to assess the color of MIH-affected permanent incisors and the adjacent sound enamel

Time frame

12 months (Evaluations will be conducted at follow-up intervals: 1 month, 3 months, 6 months, 9 months and 12 months after the trial starts).

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

King Abdulaziz University

Lead sponsor

Source ClinicalTrials.gov

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