Clinical trial

Evaluation of Three Different Minimally Invasive Techniques for Management of Enamel Opacities in Patients With Molar Incisor Hypomineralization "Randomized Controlled Clinical Trial"

Name
PED23-4D
Description
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 arms
Trial start
2023-12-01
Estimated PCD
2025-06-01
Trial end
2025-08-01
Status
Not yet recruiting
Phase
Early phase I
Treatment
Resin infiltration
Icon Resin Infiltration as minimally invasive technique
Arms:
Group A
Resin modified glass ionomer varnish
Resin modified glass ionomer varnish as minimally invasive technique
Arms:
Group B
Light cured giomer varnish
Light cured giomer varnish as minimally invasive technique
Arms:
Group C
Size
75
Primary endpoint
Variation in mineral density
It will be evaluated preoperatively and at 1, 3,6,12 and 18 months follow up.
Hypersensitivity
It will be evaluated pre operative and at 1, 3,6,12 and 18 months follow up.
Eligibility criteria
Inclusion Criteria: * 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. Exclusion Criteria: * 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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}}, 'enrollmentInfo': {'count': 75, 'type': 'ESTIMATED'}}
Updated at
2023-11-18

1 organization

3 products

1 indication