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

NCT07799350 | Not Yet Recruiting DMC

• 1 other identifier: 14422025471541
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

White Spot Lesion of Tooth

Keywords

resin infiltration

Outcome Measures

Primary Outcomes (1)

• 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

  baseline , 3months , 6 months and 12 months

Study Arms (2)

ICON resin infiltration

ACTIVE COMPARATOR

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.

Behavioral: light cured low viscosity resin infiltration

IMATE resin infiltration

EXPERIMENTAL

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.

Behavioral: light cured low viscosity resin infiltration

Interventions

light cured low viscosity resin infiltration BEHAVIORAL

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

ICON resin infiltration; IMATE resin infiltration

Eligibility Criteria

• Age: 16 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Cairo Univesity

Cairo, Egypt

Location

Central Study Contacts

manar khaled, bachelor degree (BDS)

CONTACT

01060631025; Manar_said@dentistry.cu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: double (participant , outcome assesor )
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: dr. asmaa yassen

Study Record Dates

• First Submitted: August 27, 2026
• First Posted: September 2, 2026
• Study Start: August 29, 2026
• Primary Completion (Estimated): August 29, 2027
• Study Completion (Estimated): September 22, 2027
• Last Updated: September 2, 2026

Record last verified: 2026-08

Locations

EG (1)