Clinical trial NCT06515548: Assessment the Efficacy of Vitamin D Mouth Rinse Versus Placebo in the Treatment of MIH
Official title: Assessment the Efficacy of Vitamin D Mouth Rinse Versus Placebo in the Treatment of Molar Incisor Hypomineralization. A Randomized Double-Blind Placebo Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Molar Incisor Hypomineralization
Keywords: vitamin D
MIH
vitamin D mouth rinse
Molar Incisor Hypomineralization
vitamin D mouthwash
Topical vitamin D
Lead sponsor: Cairo University
Sponsor class: OTHER
Collaborators: name: MTI University
First posted: 2024-07-23
Enrollment: 32
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A Randomized controlled Clinical Trial.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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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Primary outcomes:
measure: MIH TNI
timeFrame: 3 months
measure: Gingival Index
timeFrame: 3 months
measure: Plaque Index
timeFrame: 3 months
Secondary outcomes:
measure: Bleeding on Probing
timeFrame: 3 months
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Cairo University, Faculty of Dentistry.
Study officials:
affiliation: MTI University
name: Parryhan M Abdelsamie, PhD
role: PRINCIPAL_INVESTIGATOR
References: