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

NCT06515548 | Completed Phase 1 DMC

• 1 other identifier: PMTIU
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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?

Conditions

Molar Incisor Hypomineralization

Keywords

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

Outcome Measures

Primary Outcomes (3)

• MIH TNI

  3 months

• Gingival Index

  3 months

• Plaque Index

  3 months

Secondary Outcomes (1)

• Bleeding on Probing

  3 months

Study Arms (2)

Vitamin D mouthwash

ACTIVE COMPARATOR

a

Drug: Vitamin D3 mouth wash

Placebo mouth wash

PLACEBO COMPARATOR

Drug: Vitamin D3 mouth wash

Interventions

Vitamin D3 mouth wash DRUG

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

Also known as: Vitamin D3 mouth rinse

Placebo mouth wash; Vitamin D mouthwash

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Cairo University: lead
• MTI University: collaborator

Study Sites (1)

Cairo University, Faculty of Dentistry.

Giza, 12613, Egypt

Location

MeSH Terms

Conditions

Molar Hypomineralization

Condition Hierarchy (Ancestors)

Dental Enamel Hypomineralization; Developmental Defects of Enamel; Tooth Abnormalities; Stomatognathic System Abnormalities; Stomatognathic Diseases; Tooth Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Parryhan M Abdelsamie, PhD

  MTI University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Double-Blind Placebo
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of periodontology

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

Study Record Dates

• First Submitted: July 17, 2024
• First Posted: July 23, 2024
• Study Start: August 30, 2024
• Primary Completion: February 1, 2025
• Study Completion: March 30, 2025
• Last Updated: March 12, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)