NCT06135272

Brief Summary

The controlled clinical trial will be done to evaluate Resin infiltration, Resin modified glass ionomer varnish and Light cured giomer varnish as minimally invasive techniques for management of enamel opacities of patients with molar incisor hypomineralization. Variation in mineral density of the enamel opacity , ,Hypersensitivity, Color change of the enamel opacity, Quality of life of the patient, Parent Satisfaction will be evaluated preoperatively and at 1, 3,6,12 and 18 months of follow up.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
75

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Dec 2023

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 13, 2023

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 18, 2023

Completed
13 days until next milestone

Study Start

First participant enrolled

December 1, 2023

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2025

Completed
Last Updated

November 18, 2023

Status Verified

November 1, 2023

Enrollment Period

1.5 years

First QC Date

November 13, 2023

Last Update Submit

November 13, 2023

Conditions

Molar Incisor Hypomineralization

Keywords

MIHMolar Incisor Hypomineralizationenamel opacitiesgiomer varnishICONResin infiltrationClinpro xtresin modified glass ionomer varnish

Outcome Measures

Primary Outcomes (2)

  • Variation in mineral density

    Variation in mineral density of the enamel opacity using laser fluorescence.

    It will be evaluated preoperatively and at 1, 3,6,12 and 18 months follow up.

  • Hypersensitivity

    Hypersensitivity using VAS scale

    It will be evaluated pre operative and at 1, 3,6,12 and 18 months follow up.

Secondary Outcomes (3)

  • Color change of the enamel opacity

    It will be evaluated preoperatively and at 1, 3,6,12 and 18 months of follow up.

  • Quality of life of the patient

    It will be evaluated preoperatively and at 1, 3,6,12 and 18 months of follow up.

  • Parent Satisfaction

    It will be evaluated preoperatively and at 1, 3,6,12 and 18 months of follow up.

Study Arms (3)

Group A

ACTIVE COMPARATOR

Resin infiltration

Drug: Resin infiltration

Group B

EXPERIMENTAL

Resin modified glass ionomer varnish

Drug: Resin modified glass ionomer varnish

Group C

EXPERIMENTAL

Light cured giomer varnish

Drug: Light cured giomer varnish

Interventions

Resin infiltrationDRUG

Icon Resin Infiltration as minimally invasive technique

Group A
Resin modified glass ionomer varnishDRUG

Resin modified glass ionomer varnish as minimally invasive technique

Group B
Light cured giomer varnishDRUG

Light cured giomer varnish as minimally invasive technique

Group C

Eligibility Criteria

Age6 Years - 10 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Patient with molar incisor hypomineralization having at least one incisor and/or molar mildly affected.
  • Patient's age ranges from 6 to 10 years old.
  • The affected tooth has demarcated opacity without post eruptive enamel breakdown.
  • No cavitated lesion is related to the defect or previous restorative or preventive treatment.
  • The tooth is free from any symptoms of irreversible pulp inflammation.

You may not qualify if:

  • Children who are physically or mentally disabled or having any medical condition that will affect or complicate the treatment.
  • Incisors previously subjected to trauma that might lead to loss of tooth structure or compromised the pulp vitality.
  • Loss of tooth structure due to caries.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ain Shams University

Cairo, Egypt

Location

MeSH Terms

Conditions

Molar Hypomineralizationenamel opacities

Condition Hierarchy (Ancestors)

Dental Enamel HypomineralizationDevelopmental Defects of EnamelTooth AbnormalitiesStomatognathic System AbnormalitiesStomatognathic DiseasesTooth DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Central Study Contacts

Hagar M Mohie

CONTACT

0020100509369hmohie@msa.edu.eg

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD researcher

Study Record Dates

First Submitted

November 13, 2023

First Posted

November 18, 2023

Study Start

December 1, 2023

Primary Completion

June 1, 2025

Study Completion

August 1, 2025

Last Updated

November 18, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)