White Spot Lesions
Conditions
Keywords
white spot lesions, fixed orthodontic brackets, fluoride varnish, fluoride gel
Brief summary
Study will look at ability of fluoride varnish to remineralize white spot enamel lesions that can occur around the edge of fixed orthodontic brackets.
Detailed description
To determine the efficacy of 5% sodium fluoride varnish with tricalcium phosphate in reverting white spot lesions after fixed orthodontic treatment, compared with a fluoride gel.
Interventions
DEVICEVanish Varnish
5% sodium fluoride varnish with tricalcium phosphate
DEVICEPediagel
1.23% Acidulated Phosphate Fluoride Gel
Sponsors
University of Tennessee
3M
Solventum US LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
12 Years to 16 Years
Healthy volunteers
Yes
Inclusion criteria
* no systemic disease * has completed fixed orthodontic treatment, brackets debonded * has at least two teeth with whitre spot lesions * has received conventional periodontal therapy after orthodontic tretament
Exclusion criteria
* presence of enamel hypoplasia or dental fluorosis * presence of tetracycline pigmentation * periodontal pocketing of 3mm or greater * taking antibiotics * presence of carious cavities * allergy to fluoride gel / varnish being used in study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| DIAGNOdent Readings at Baseline, Three and Six Months - Intergroup Comparison | Baseline, Three and Six Month | Outcome of fluoride varnish or gel application to white spot lesions as measured by DIAGNOdent device after orthodontic debonding. Values shown represent the mean DIAGNOdent reading. The DIAGNOdent scale spans values from 0 to 30+ where larger values indicate higher levels of demineralization. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Pediagel 1.23% Acidulated Phosphate Fluoride Gel | 23 |
| Pediagel 1.23% Acidulated Phosphate Fluoride Gel | 106 |
| Vanish Varnish 5% sodium fluoride varnish with tricalcium phosphate | 15 |
| Vanish Varnish 5% sodium fluoride varnish with tricalcium phosphate | 74 |
| Total | 218 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 6 | 0 |
Baseline characteristics
| Characteristic | Pediagel | Vanish Varnish | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 23 Participants | 15 Participants | 38 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Female | 11 Participants | 8 Participants | 19 Participants |
| Sex: Female, Male Male | 12 Participants | 7 Participants | 19 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 19 | 0 / 19 |
| other Total, other adverse events | 0 / 19 | 0 / 19 |
| serious Total, serious adverse events | 0 / 19 | 0 / 19 |
Outcome results
Primary
DIAGNOdent Readings at Baseline, Three and Six Months - Intergroup Comparison
Outcome of fluoride varnish or gel application to white spot lesions as measured by DIAGNOdent device after orthodontic debonding. Values shown represent the mean DIAGNOdent reading. The DIAGNOdent scale spans values from 0 to 30+ where larger values indicate higher levels of demineralization.
Time frame: Baseline, Three and Six Month
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Pediagel | DIAGNOdent Readings at Baseline, Three and Six Months - Intergroup Comparison | Baseline | 5.10 units on a scale | Standard Deviation 2.67 |
| Pediagel | DIAGNOdent Readings at Baseline, Three and Six Months - Intergroup Comparison | Three Months | 4.08 units on a scale | Standard Deviation 2.32 |
| Pediagel | DIAGNOdent Readings at Baseline, Three and Six Months - Intergroup Comparison | Six Months | 3.52 units on a scale | Standard Deviation 2.46 |
| Vanish Varnish | DIAGNOdent Readings at Baseline, Three and Six Months - Intergroup Comparison | Baseline | 6.01 units on a scale | Standard Deviation 4.17 |
| Vanish Varnish | DIAGNOdent Readings at Baseline, Three and Six Months - Intergroup Comparison | Three Months | 5.50 units on a scale | Standard Deviation 3.81 |
| Vanish Varnish | DIAGNOdent Readings at Baseline, Three and Six Months - Intergroup Comparison | Six Months | 3.95 units on a scale | Standard Deviation 2.97 |
Comparison: Null Hypothesis: there is no intergroup difference (α=0.05) in DIAGNOdent reading at baselinep-value: 0.636ANOVA
Comparison: Null Hypothesis: there is no intergroup difference (α=0.05) in DIAGNOdent reading at three monthsp-value: 0.001ANOVA
Comparison: Null Hypothesis: there is no intergroup difference (α=0.05) in DIAGNOdent reading at six monthsp-value: 0.423ANOVA