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Assessment of the Remineralization Efficacy of Vitamin D in the Treatment of MIH. In Vitro Study and In Situ Randomized Double-Blind Placebo Clinical Trial.

Assessment of the Remineralization Efficacy of Vitamin D in the Treatment of Molar Incisor Hypomineralization. In Vitro Study and In Situ Randomized Double-Blind Placebo Controlled Clinical Trial.

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06515548
Enrollment
32
Registered
2024-07-23
Start date
2024-08-30
Completion date
2025-03-30
Last updated
2026-07-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Molar Incisor Hypomineralization

Keywords

vitamin D, MIH, vitamin D mouth rinse, Molar Incisor Hypomineralization, vitamin D mouthwash, Topical vitamin D

Brief summary

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?

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.

Interventions

DRUGVitamin D3 mouth wash

topical vitamin D oral mouth wash as every 10ml of the solution contains 3000 IU

Sponsors

Cairo University
Lead SponsorOTHER
MTI University
CollaboratorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Masking description

Double-Blind Placebo

Intervention model description

In vitro study and in situ Randomized Double-Blind Placebo controlled Clinical Trial.

Eligibility

Sex/Gender
ALL
Age
6 Years to 12 Years
Healthy volunteers
Yes

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 \-

Design outcomes

Primary

MeasureTime frame
MIH TNI3 months
Gingival Index3 months
Plaque Index3 months

Secondary

MeasureTime frame
Bleeding on Probing3 months

Countries

Egypt

Contacts

PRINCIPAL_INVESTIGATORParryhan M Abdelsamie, PhD

MTI University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 7, 2026