Efficacy Evaluation of Two Different Fluoride Applications

Ivoclar Vivadent

Status: Completed

Conditions: White Spot Lesion

Treatments: Device: Fluoride Application (Experimental Fluoride Application); Device: Fluor Protector S

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06131294

LL4470462

Details and patient eligibility

About

The goal of this clinical trial is to evaluate the remineralizing or preservative effect of two different fluoride-containing products. The main question aims to answer how the mineral content of the active white spot lesions change after the treatment with those two fluoride applications in a split-mouth design by measuring their mineral content via QLF technology.

Each patient will receive both treatments in a split-mouth design. It is comparison between an experimental fluoride application and Fluoride Protector S.

Enrollment: 23 patients

Sex: All

Ages: 13 to 50 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• At least two active non-cavitated white spot lesions on buccal surfaces of anterior teeth or premolars (ICDAS code 1 and 2; Nyvad score 1) in two different quadrants.
• Age between 13 and 50 years
• No untreated caries lesions or periodontal disease
• No systematic disease or medication (such as antidepressants, antibiotics etc.) that affects salivary flow rate
• Subjects claimed regular brushing at least twice a day
• Subjects had to agree to keep the scheduled recall appointments for at least 1 year.

Exclusion criteria

• Inactive non-cavitated lesions (Nyvad Score 4)
• Lesions with microcavity, cavitation, chipping or discoloration
• Lesions at buccal side of the molars
• Lesions adjacent to restoration
• Developmental white spot lesions such as enamel hypoplasia
• Pregnancy

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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23 participants in 2 patient groups

Expermental Fluoride Application

Experimental group

Description:

The two-step system, consisting of Component A (ammonium fluoride solution) and Component B (calcium fluoride application), will be applied once on the white spot lesions one.

Treatment:

Device: Fluoride Application (Experimental Fluoride Application)

Fluor Protector S

Active Comparator group

Description:

The ammonium fluoride gel will be applied once on the white spot lesions.

Treatment:

Device: Fluor Protector S