Efficacy Evaluation of Two Different Fluoride Applications

White Spot Lesion Clinical Trial

Official title:

Evaluation of Effectiveness of a Novel Remineralizing Agent: A Randomized Controlled Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06131294
• Other study ID #: LL4470462
• Status: Completed
• Phase: N/A
• Start date: February 24, 2023
• Est. completion date: April 16, 2024

Study information

• Verified date: November 2023
• Source: Ivoclar Vivadent AG
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: April 16, 2024
• Est. primary completion date: May 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 13 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• White Spot Lesion

Intervention

Device:
• Fluoride Application (Experimental Fluoride Application)
Fluoride containing applications are applied on white spot lesions. First solution was air-dried before the second application with the other component was done.
• Fluor Protector S
Fluor Protector S is applied on white spot lesions.

Locations

Country	Name	City	State
Turkey	Istanbul Medipo University	Istanbul	Esenler

Sponsors (2)

Lead Sponsor	Collaborator
Ivoclar Vivadent AG	Istanbul Medipol University Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Safety Parameters	Occurence of adverse device effects: allergic reactions or irritations on mucosa	Baseline to 1 year
Primary	White Spot Measurement	Analysis of incipient caries or demineralized enamel by quantified results of delta F and delta R values (QLF technology). These values indicate the degree of demineralization.	Baseline to 1 year
Secondary	ICDAS II visual scoring system (Codes)	Evaluation of the clinical status of the lesions: 0: Sound tooth surface: No evidence of caries after 5 sec air drying; First visual change in enamel: Opacity or discoloration (white or brown) is visible at the entrance to the pit or fissure seen after prolonged air drying; Distinct visual change in enamel visible when wet, lesion must be visible when dry; Localized enamel breakdown (without clinical visual signs of dentinal involvement) seen when wet and after prolonged drying; Underlying dark shadow from dentin; Distinct cavity with visible dentin; Extensive (more than half the surface) distinct cavity with visible dentin	Baseline to 1 year
Secondary	Nyvad criteria	Evaluation of the clinical status of the lesions: 0: Sound; Active caries (intact surface); Active caries (surface discontinuity); Active caries (cavity); Inactive caries (intact surface); Inactive caries (surface discontinuity); Inactive caries (cavity); Filling (sound surface); Filling+active caries; Filling+inactive caries X: Extracted because of caries Lost because of caries	Baseline to 1 year