Assessment of the Remineralization Efficacy of Vitamin D in the Treatment of MIH and Its Role in Improving Oral Hygiene and Gingival Health. In Situ Randomized Double-Blind Placebo CT

Assessment of the Remineralization Efficacy of Vitamin D in the Treatment of Molar Incisor Hypomineralization and Its Role in Improving Oral Hygiene and Gingival Health. In Situ Randomized Double-Blind Placebo Controlled Clinical Trial

In child patients with molar incisor hypo mineralization, Will Vitamin D mouth wash offer more success for patients with MIH as regards better MIH TNI index, decrease plaque accumulation, more gingival health and less bleeding on probing differentiated from placebo mouthwash?

Study Overview

• Status: Completed
• Conditions: Molar Incisor Hypomineralization
• Intervention / Treatment: Drug: Vitamin D3 mouth wash

Detailed Description

Molar incisor hypomineralization (MIH) refers to specific developmental qualitative defect of the enamel that typically affect 1 to all 4 of the permanent molars and can also involve the permanent incisors.

MIH is clinically characterized by morphological enamel defects that can be seen on the occlusal surface of permanent molars and the incisal one-third (or more) of the incisors result from hypomineralization. These defects more or less well-defined opacities that vary in size and can be discoloured from white to yellow brownish. The hypomineralized enamel is friable and has inferior mechanical properties as well as reduced modulus of elasticity when compared to sound enamel.

As a consequence, hypomineralized enamel leads to post-eruptive breakdown and hypersensitivity, and it is prone to development of carious lesions and pain. Due to pain, fragile enamel and increased treatment need at an early point of time in life, MIH treatment represents a clinical challenge. The well-defined opacities are focal subsurface decalcifications in enamel are commonly associated with extended plaque retention. Periodontal disease in children is mainly limited to gingival inflammation and is observed as gingival oedema, colour and contour changes, bleeding on probe or spontaneous bleeding.

Recent study showed that plaque accumulation and gingival inflammation were higher in patients with MIH compared with healthy children, and that oral hygiene and gingival health worsened as the severity of MIH increased.

Vitamin D, plays a pivotal role in many biological functions such as in innate immunity effect, the regulation of calcium (Ca+) and phosphate metabolism and their deposition in mineralized tissues. Since the presence of Vitamin D3 receptors on ameloblast and odontoblast cells, its function in tooth development and remineralization, changes in the biochemical composition of saliva and immunological modulation of dental infection has been suggested.

Vitamin D has been demonstrated to have significant potential in improving the remineralization of early lesions on enamel surfaces enhancing surface microhardness and minerals content. Remineralization is defined as the process whereby calcium and phosphate ions are supplied from a source external to the tooth to promote ion deposiption into crystal voids in demineralized enamel, to produce net mineral gain.

Recent ex-vivo study revealed that the topical application of fluoride and vitamin D promoted the formation of persistent mineral crystals on enamel surfaces of deciduous teeth. Consequently, this study recommends further evaluation to be potentially used as an alternative strategy.

The treatment of teeth affected by MIH should be a minimally invasive procedure that aims to protect, strengthen and preserve dental structure. Numerous therapeutic alternatives have been proposed over time for the treatment of MIH-affected teeth, but the clinical management of these conditions is very demanding and less conservative.

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Phase 1

Contacts and Locations

Study Locations

• Egypt
  • Giza, Egypt, 12613
    • Cairo University, Faculty of Dentistry.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. More than 6 years' child with all permanent incisors and first molar teeth are fully erupted with all surfaces visible.
2. At least one affected first permanent molar were considered to have MIH (Lygidakis et al. 2010; Kühnisch et al. 2014).
3. No chronic systemic disease
4. No acute infection
5. cooperative Child

Exclusion Criteria:

1. Drugs (chlorhexidine-based gels and mouthwashes)
2. Hypomineralization with a diameter less than 1 mm.
3. Hypoplastic defects, fluorosis (diffuse hypomineralization), amelogenesis imperfecta, and dentinogenesis imperfecta.
4. Defects on approximal surfaces and diffuse opacities.

5. Fixed orthodontic treatment

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Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Vitamin D mouthwash; a	Drug: Vitamin D3 mouth wash; topical vitamin D oral mouth wash as every 10ml of the solution contains 3000 IU; Other Names: Vitamin D3 mouth rinse
Placebo Comparator: Placebo mouth wash	Drug: Vitamin D3 mouth wash; topical vitamin D oral mouth wash as every 10ml of the solution contains 3000 IU; Other Names: Vitamin D3 mouth rinse

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Gingival Index	3 months
MIH TNI	3 months
Plaque Index	3 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Bleeding on Probing	3 months

Collaborators and Investigators

• Sponsor: Cairo University
• Collaborators: MTI University
• Investigators: Principal Investigator: Parryhan M Abdelsamie, PhD, MTI University

Study record dates

Study Major Dates

• Study Start (Actual): August 30, 2024
• Primary Completion (Actual): February 1, 2025
• Study Completion (Actual): March 30, 2025

Study Registration Dates

• First Submitted: July 17, 2024
• First Submitted That Met QC Criteria: July 22, 2024
• First Posted (Actual): July 23, 2024

Study Record Updates

• Last Update Posted (Actual): March 12, 2026
• Last Update Submitted That Met QC Criteria: March 11, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: vitamin D; MIH; Molar Incisor Hypomineralization; vitamin D mouth rinse; vitamin D mouthwash; Topical vitamin D
• Additional Relevant MeSH Terms: Dental Enamel Hypomineralization; Developmental Defects of Enamel; Stomatognathic Diseases; Tooth Diseases; Stomatognathic System Abnormalities; Congenital Abnormalities; Tooth Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Molar Hypomineralization; Calcium-Regulating Hormones and Agents; Physiological Effects of Drugs; Bone Density Conservation Agents; Micronutrients; Vitamin D; Ergocalciferols; Vitamins; Cholecalciferol
• Other Study ID Numbers: PMTIU

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