Orthodontic Treatment, White Spot Lesion
Conditions
Keywords
Enamel decalcification
Brief summary
The current study aimed to determine if MI Varnish has an effect in preventing the formation of white spot lesions for patients undergoing orthodontic treatment. 33 subjects were prospectively recruited for the project as the MI Varnish group, with a control group of 29 orthodontically treated subjects who received routine treatment and oral hygiene regimes.Difference in prevention of white spot formation between the control and the study groups were evaluated through photographic records and clinical examination by using the Enamel Decalcification Index (EDI) scores.
Detailed description
Orthodontists face two common iatrogenic treatment side effects, root resorption and enamel decalcification, with the latter occurring at a much higher frequency. While the processes that lead to enamel demineralization are understood, methods to diminish or perhaps eliminate degradation of enamel surfaces are being searched for. A new product, MI Varnish, is current available and has been shown in some initial case reports to be useful in reducing white spot lesions. It contains a special milk-derived protein RECALDENT TM (CPP-ACP) in which the casein phosphopeptides (CPP) bind to teeth, dentin, and oral mucosa while the amorphous calcium phosphate (ACP) releases calcium and phosphate. The current study aimed to determine if MI Varnish has an effect in preventing the formation of white spot lesions for patients undergoing orthodontic treatment. 33 subjects were prospectively recruited for the project as the MI Varnish group, with a control group of 29 orthodontically treated subjects who received routine treatment and oral hygiene regimes. The study group received the MI Varnish on the day of bracket bonding. Subjects were recalled initially for 4 weeks (twice) and then at 3 monthly intervals. Difference in prevention of white spot formation between the control and the study groups were evaluated through photographic records and clinical examination by using the Enamel Decalcification Index (EDI) scores.
Interventions
DRUGMI Varnish
MI Varnish with RECALDENT™ (CPP-ACP) enhances enamel acid resistance and boosts salivary fluoride levels. This product remains on the teeth longer than other fluoride varnishes and contains high levels of fluoride and calcium released in the oral cavity. The difference is in the RECALDENT™ (CPP-ACP), which makes MI Varnish a natural and unique choice for your patients. Casein phosphopeptides (CPP) naturally occurs in milk casein; Amorphous Calcium Phosphate (ACP), which is found in the RECALDENT™, is also the source of calcium and phosphate. In the oral cavity, CPP binds to oral surfaces such as teeth, dentin, oral mucosa and biofilm. Calcium and phosphate ions are the building blocks for healthy teeth and MI Varnish delivers bioavailable calcium and phosphate ions into the saliva.
OTHERControl group
Participants received routine treatment and oral hygiene regimes. No intervention for this group.
Sponsors
University of Alabama at Birmingham
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Intervention model description
33 subjects were prospectively recruited for the project in the MI Varnish group. These subjects were studied against a control group of 29 orthodontically treated subjects who received routine treatment and oral hygiene regimes. All subjects will be patients seeking orthodontic treatment at the Department of Orthodontics, School of Dentistry, University of Alabama at Birmingham.
Eligibility
Sex/Gender
ALL
Age
10 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
* Patients seeking orthodontic treatment and receiving routine treatment and oral hygiene regimes.
Exclusion criteria
* Any medical or dental condition that in the opinion of the investigator could impact study results during the expected length of the study; * Patient is currently using any investigational drug or any other investigational device; * Patient plans to relocate or move within six months of enrollment.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Enamel Decalcification Index (EDI) Scores | Photographs were taken for 4 times at monthly intervals. EDI scores were measured and assessed at 1, 2, 3 and 4 months, Month 4 reported. The duration of the observation is an average of 4 months. | Photographic records will be used to determine the improvements in the white spot lesions. A standard intra-oral photographic camera will be utilized and the photographs will be taken in a light controlled environment and photographs will be captured in a pre-set photographic protocol. The Enamel decalcification index (EDI) will be used to determine the number of white spot lesions present at each time frame.Enamel decalcification index calculation: The facial surface of each tooth was divided into 4 areas (m, Mesial; g, gingival; d, distal; o, occlusal). A score was allocated for each area of each tooth: 0, no decalcification, to 3, decalcifications covering 100% of the area at each time period. Analysis was done at the tooth level, aggregating the enamel decalcification scores from all four areas, creating an EDI for each tooth ranging potentially from 0 to 12. Higher EDI scores indicate more decalcification of teeth and represent a worse outcome. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| MI Varnish Group 33 subjects were prospectively recruited for the project in the MI Varnish group. All subjects will be patients seeking orthodontic treatment at the Department of Orthodontics, UAB. | 26 |
| Control Group A control group was comprised of 29 orthodontically treated subjects who received routine treatment and oral hygiene regimes. All subjects were patients seeking orthodontic treatment at the Department of Orthodontics, School of Dentistry, University of Alabama at Birmingham. | 29 |
| Total | 55 |
Baseline characteristics
| Characteristic | MI Varnish Group | Control Group | Total |
|---|---|---|---|
| Age, Continuous | 29.5 years STANDARD_DEVIATION 6.7 | 28.5 years STANDARD_DEVIATION 5.2 | 29 years STANDARD_DEVIATION 5.94 |
| Region of Enrollment Africa | 6 Participants | 9 Participants | 15 Participants |
| Region of Enrollment Central America | 18 Participants | 20 Participants | 38 Participants |
| Region of Enrollment China | 2 Participants | 0 Participants | 2 Participants |
| Sex: Female, Male Female | 16 Participants | 16 Participants | 32 Participants |
| Sex: Female, Male Male | 10 Participants | 13 Participants | 23 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 33 | 0 / 29 |
| other Total, other adverse events | 0 / 33 | 0 / 29 |
| serious Total, serious adverse events | 0 / 33 | 0 / 29 |
Outcome results
Primary
Enamel Decalcification Index (EDI) Scores
Photographic records will be used to determine the improvements in the white spot lesions. A standard intra-oral photographic camera will be utilized and the photographs will be taken in a light controlled environment and photographs will be captured in a pre-set photographic protocol. The Enamel decalcification index (EDI) will be used to determine the number of white spot lesions present at each time frame.Enamel decalcification index calculation: The facial surface of each tooth was divided into 4 areas (m, Mesial; g, gingival; d, distal; o, occlusal). A score was allocated for each area of each tooth: 0, no decalcification, to 3, decalcifications covering 100% of the area at each time period. Analysis was done at the tooth level, aggregating the enamel decalcification scores from all four areas, creating an EDI for each tooth ranging potentially from 0 to 12. Higher EDI scores indicate more decalcification of teeth and represent a worse outcome.
Time frame: Photographs were taken for 4 times at monthly intervals. EDI scores were measured and assessed at 1, 2, 3 and 4 months, Month 4 reported. The duration of the observation is an average of 4 months.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| MI Varnish Group | Enamel Decalcification Index (EDI) Scores | Total EDI score of 2-month visit | 1.308 scores on a scale |
| MI Varnish Group | Enamel Decalcification Index (EDI) Scores | Total EDI score of 4-month visit | 2.692 scores on a scale |
| MI Varnish Group | Enamel Decalcification Index (EDI) Scores | Total EDI score of 1-month visit | 1.038 scores on a scale |
| MI Varnish Group | Enamel Decalcification Index (EDI) Scores | Total EDI score of 3-month visit | 1.923 scores on a scale |
| Control Group | Enamel Decalcification Index (EDI) Scores | Total EDI score of 3-month visit | 3.966 scores on a scale |
| Control Group | Enamel Decalcification Index (EDI) Scores | Total EDI score of 2-month visit | 2.724 scores on a scale |
| Control Group | Enamel Decalcification Index (EDI) Scores | Total EDI score of 1-month visit | 1 scores on a scale |
| Control Group | Enamel Decalcification Index (EDI) Scores | Total EDI score of 4-month visit | 5.897 scores on a scale |