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NCT Number: NCT07799350

Clinical Outcomes, Cost-Effectiveness and Patient Satisfaction of Two Resin Infiltration Systems for The Management of White Spot Lesions

The aim of this study is to clinically evaluate and compare the color matching of white spot lesions (WSLs) following treatment with two resin infiltration systems: ICON resin infiltration and I-Mate resin infiltration. The study will assess the ability of both materials to improve the esthetic appearance of white spot lesions and achieve a color match with the surrounding natural tooth structure.

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Key information

Age range

16 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cairo Univesity

Cairo, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

light cured low viscosity resin infiltration

Behavioral

light cured low viscosity resin infiltration used to mask white spot lesion appearance

Primary outcomes

  1. color matching of the treated white spot lesion with the adjacent natural tooth structure

    Time frame: baseline , 3months , 6 months and 12 months

    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

Study contacts

Contact information is provided by the study sponsor or research team.

manar khaled, bachelor degree (BDS)

CONTACT

[email protected]

01060631025

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Sep 2, 2026
Registry last updated
Sep 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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