Clinical Outcomes, Cost-Effectiveness and Patient Satisfaction of Two Resin Infiltration Systems for The Management of White Spot Lesions
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
White spot lesions (WSLs) are a common esthetic complication associated with orthodontic treatment and are characterized by subsurface enamel demineralization with preservation of the superficial enamel layer. These lesions may remain visible after orthodontic appliance removal and can negatively affect the patient's dental esthetics and satisfaction.
Resin infiltration is a minimally invasive treatment approach that aims to arrest the progression of early enamel caries and improve the optical appearance of WSLs. The infiltration of a low-viscosity resin into the porous enamel lesion modifies the refractive properties of the lesion and may reduce the visual contrast between the white spot lesion and the surrounding sound enamel.
This randomized controlled clinical trial will compare two resin infiltration systems, ICON and I-Mate, in the management of white spot lesions. Participants with eligible white spot lesions will be randomly allocated to receive treatment with either ICON resin infiltration or I-Mate resin infiltration according to the manufacturers' recommended clinical protocols.
The primary outcome of the study will be the clinical color matching of the treated white spot lesions with the adjacent natural tooth structure. Color matching will be evaluated using standardized clinical assessment criteria to determine the esthetic improvement achieved following resin infiltration treatment.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: manar khaled, bachelor degree (BDS)
- Phone Number: 01060631025
- Email: Manar_said@dentistry.cu.edu.eg
Study Locations
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Cairo, Egypt
- Cairo Univesity
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
Patients presenting with non-cavitated white spot lesions on anterior permanent teeth.
White spot lesions associated with previous orthodontic treatment. Lesions with intact surface enamel and no cavitation. Patients aged 16 to 35 years. Patients with good oral hygiene. Patients willing to participate in the study. Patients able to attend the scheduled follow-up visits. Patients who provide informed consent.
Exclusion Criteria:
Cavitated carious lesions. Spontaneous or elicited pain associated with the affected tooth. Tooth mobility. Signs or symptoms of pulpal or periapical pathology. Severe periodontal or oral conditions that may interfere with treatment or assessment.
Developmental enamel defects or other conditions that may interfere with assessment of white spot lesions.
Known allergy or sensitivity to any component of the materials used in the study.
Teeth with previous esthetic restorations or other treatments that may affect color assessment.
Patients unable to attend the scheduled follow-up visits. Poor oral hygiene that may interfere with treatment or assessment. Refusal to participate in the study.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: ICON resin infiltration
ICON resin infiltration is a minimally invasive treatment for non-cavitated white spot lesions.
The lesion surface will be prepared according to the manufacturer's recommended clinical protocol, followed by application of ICON-Dry and ICON-Infiltrant to allow resin penetration into the porous enamel lesion.
The resin will then be light-cured according to the manufacturer's instructions, followed by finishing and polishing.
|
light cured low viscosity resin infiltration used to mask white spot lesion appearance
|
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Experimental: IMATE resin infiltration
I-Mate resin infiltration will be applied for the management of non-cavitated white spot lesions according to the manufacturer's recommended clinical protocol.
The lesion will be appropriately prepared to facilitate resin penetration, followed by application and light-curing of the infiltrant according to the manufacturer's instructions.
Finishing and polishing will be performed after resin infiltration.
|
light cured low viscosity resin infiltration used to mask white spot lesion appearance
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
color matching of the treated white spot lesion with the adjacent natural tooth structure
Time Frame: baseline , 3months , 6 months and 12 months
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Color match of treated teeth will be assessed using the FDI World Dental Federation Esthetic Criteria. The color match will be evaluated using the FDI 5-point ordinal scale, and the mean color match score will be calculated for each treatment group. Measurement: Color match score Measurement tool: FDI World Dental Federation Esthetic Criteria Unit: FDI color match score |
baseline , 3months , 6 months and 12 months
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 14422025471541
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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