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.

July 2, 2026 updated by: Parryhan Mohamed Abdelsamie, Cairo University

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.

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

Intervention / Treatment

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

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

    -

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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
Time Frame: 3 months
3 months
MIH TNI
Time Frame: 3 months
3 months
Plaque Index
Time Frame: 3 months
3 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Bleeding on Probing
Time Frame: 3 months
3 months

Other Outcome Measures

Outcome Measure
Time Frame
Vickers microhardness tester
Time Frame: 3 months
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Collaborators

MTI University

Investigators

  • Principal Investigator: Parryhan M Abdelsamie, PhD, MTI University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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)

July 6, 2026

Last Update Submitted That Met QC Criteria

July 2, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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