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

N/ANot Yet RecruitingNCT07799350

Cairo University50 enrolled

Overview

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.

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

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

Conditions

White Spot Lesion of Tooth

Interventions

light cured low viscosity resin infiltrationBEHAVIORAL

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

Eligibility

Sex: ALLMin age: 16 YearsMax age: 35 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Cairo Univesity

Cairo, Egypt

Outcomes

Primary Outcomes

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

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

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

Central Contacts

manar khaled, bachelor degree (BDS)

CONTACT

01060631025 Manar_said@dentistry.cu.edu.eg

Data from ClinicalTrials.gov

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