Evaluation of Effectiveness of a Novel Remineralizing Agent: A Randomized Controlled Clinical Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Ivoclar Vivadent AG
- Enrollment
- 23
- Locations
- 2
- Primary Endpoint
- Measurement of White Spot Lesions by QLF Parameters: Delta F (Max)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 13 Years to 50 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Measurement of White Spot Lesions by QLF Parameters: Delta F (Max)
Time Frame: 12 Month
Evaluation of the change in lesion size of white spot areas and mineral content by measurement of QLF parameters: \- delta F (max) (Percentage of maximal fluorescence loss at lesion sites compared to fluorescence of normal enamel, relative fluorecence loss)
Measurement of White Spot Lesions by QLF Parameters: Delta F (Average)
Time Frame: 12 Month
Evaluation of the change in lesion size of white spot areas and mineral content by measurement of QLF parameters: \- delta F (average) (Percentage of average fluorescence loss at lesion sites compared to fluorescence of normal enamel, relative fluorecence loss)
Measurement of White Spot Lesions by QLF Parameters: WSA
Time Frame: 12 Month
Evaluation of the change in lesion size of white spot areas and mineral content by measurement of QLF parameters: \- white spot area (WSA)
Measurement of White Spot Lesions by QLF Parameters: Delta Q
Time Frame: 12 Month
Evaluation of the change in lesion size of white spot areas and mineral content by measurement of QLF parameters: delta Q \- delta Q (fluorescence loss in the lesions times with the area of white spot lesions (delta F x WSA); fluorescence loss is negative per definition as enamal has higher mineral content and thus fluorescence than white spot lesions)
Measurement of White Spot Lesions by QLF Parameters: Delta R
Time Frame: 12 Month
Evaluation of the change in lesion size of white spot areas and mineral content by measurement of QLF parameters: \- delta R (increase of red fluorescence at lesion compared to normal enaml; relative red fluorescence increase)
Measurement of White Spot Lesions by QLF Parameters: Delta F (Max)
Time Frame: 12 Month
Evaluation of the change in lesion size of white spot areas and mineral content by measurement of QLF parameters: \- delta F (max) (Percentage of maximal fluorescence loss at lesion sites compared to fluorescence of normal enamel, relative fluorecence loss)
Measurement of White Spot Lesions by QLF Parameters: Delta F (Average)
Time Frame: 12 Month
Evaluation of the change in lesion size of white spot areas and mineral content by measurement of QLF parameters: \- delta F (average) (Percentage of average fluorescence loss at lesion sites compared to fluorescence of normal enamel, relative fluorecence loss)
Measurement of White Spot Lesions by QLF Parameters: WSA
Time Frame: 12 Month
Evaluation of the change in lesion size of white spot areas and mineral content by measurement of QLF parameters: \- white spot area (WSA)
Measurement of White Spot Lesions by QLF Parameters: Delta Q
Time Frame: 12 Month
Evaluation of the change in lesion size of white spot areas and mineral content by measurement of QLF parameters: delta Q \- delta Q (fluorescence loss in the lesions times with the area of white spot lesions (delta F x WSA); fluorescence loss is negative per definition as enamal has higher mineral content and thus fluorescence than white spot lesions)
Measurement of White Spot Lesions by QLF Parameters: Delta R
Time Frame: 12 Month
Evaluation of the change in lesion size of white spot areas and mineral content by measurement of QLF parameters: \- delta R (increase of red fluorescence at lesion compared to normal enaml; relative red fluorescence increase)
Secondary Outcomes
- Severity of White Spot Lesions by ICDAS II Visual Scoring System (Codes)(Baseline)
- Severity and Activity of White Spot Lesions by Nyvad Criteria(Baseline)
- Severity Transition of White Spot Lesions by ICDAS II Visual Scoring System (Codes)(Baseline to 12 month)
- Severity and Activity Transition of White Spot Lesions by Nyvad Criteria(Baseline to 12 month)