Clinical trial NCT06131294: Efficacy Evaluation of Two Different Fluoride Applications
Official title: Evaluation of Effectiveness of a Novel Remineralizing Agent: A Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: White Spot Lesion
Keywords: white spot lesion
Lead sponsor: Ivoclar Vivadent AG
Sponsor class: INDUSTRY
Collaborators: name: Istanbul Medipol University Hospital
First posted: 2023-11-14
Enrollment: 23
Sex: ALL
Minimum age (years): 13
Maximum age (years): 50
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Split-mouth design: Meaning that each patient receives both treatments, but on different teeth.
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Measurement of White Spot Lesions by QLF Parameters: Delta F (Max)
timeFrame: Baseline
measure: Measurement of White Spot Lesions by QLF Parameters: Delta F (Average)
timeFrame: Baseline
measure: Measurement of White Spot Lesions by QLF Parameters: WSA
timeFrame: Baseline
measure: Measurement of White Spot Lesions by QLF Parameters: Delta Q
timeFrame: Baseline
measure: Measurement of White Spot Lesions by QLF Parameters: Delta R
timeFrame: Baseline
measure: Measurement of White Spot Lesions by QLF Parameters: Delta F (Max)
timeFrame: 1 Month
measure: Measurement of White Spot Lesions by QLF Parameters: Delta F (Average)
timeFrame: 1 Month
measure: Measurement of White Spot Lesions by QLF Parameters: WSA
timeFrame: 1 Month
measure: Measurement of White Spot Lesions by QLF Parameters: Delta Q
timeFrame: 1 Month
measure: Measurement of White Spot Lesions by QLF Parameters: Delta R
timeFrame: 1 Month
measure: Measurement of White Spot Lesions by QLF Parameters: Delta F (Max)
timeFrame: 6 Month
measure: Measurement of White Spot Lesions by QLF Parameters: Delta F (Average)
timeFrame: 6 Month
measure: Measurement of White Spot Lesions by QLF Parameters: WSA
timeFrame: 6 Month
measure: Measurement of White Spot Lesions by QLF Parameters: Delta Q
timeFrame: 6 Month
measure: Measurement of White Spot Lesions by QLF Parameters: Delta R
timeFrame: 6 Month
measure: Measurement of White Spot Lesions by QLF Parameters: Delta F (Max)
timeFrame: 12 Month
measure: Measurement of White Spot Lesions by QLF Parameters: Delta F (Average)
timeFrame: 12 Month
measure: Measurement of White Spot Lesions by QLF Parameters: WSA
timeFrame: 12 Month
measure: Measurement of White Spot Lesions by QLF Parameters: Delta Q
timeFrame: 12 Month
measure: Measurement of White Spot Lesions by QLF Parameters: Delta R
timeFrame: 12 Month
Secondary outcomes:
measure: Severity of White Spot Lesions by ICDAS II Visual Scoring System (Codes)
timeFrame: Baseline
measure: Severity and Activity of White Spot Lesions by Nyvad Criteria
timeFrame: Baseline
measure: Severity Transition of White Spot Lesions by ICDAS II Visual Scoring System (Codes)
timeFrame: Baseline to 1 month
measure: Severity and Activity Transition of White Spot Lesions by Nyvad Criteria
timeFrame: Baseline to 1 month
measure: Severity Transition of White Spot Lesions by ICDAS II Visual Scoring System (Codes)
timeFrame: Baseline to 6 month
measure: Severity and Activity Transition of White Spot Lesions by Nyvad Criteria
timeFrame: Baseline to 6 month
measure: Severity Transition of White Spot Lesions by ICDAS II Visual Scoring System (Codes)
timeFrame: Baseline to 12 month
measure: Severity and Activity Transition of White Spot Lesions by Nyvad Criteria
timeFrame: Baseline to 12 month
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul Medipo University
state: Esenler
Study officials:
affiliation: Istanbul Medipo University
name: Burcu Gözetici, Dr.
role: PRINCIPAL_INVESTIGATOR
References: