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The purpose of the study is o compare the efficacy of CPP-ACP MI Varnish and ProSeal sealant in preventing white spot lesion (WSL) formation in orthodontic patients.
This prospective randomized clinical trial included 40 orthodontic patients between the ages of 12-17 who were randomly allocated to two groups. Group 1 (Sealant Group) received sealant on the maxillary anterior canines, lateral incisors, and central incisors, with reapplication of the sealant every 3 months. Group 2 (Varnish Group) had MI Varnish applied every 4-6 weeks, without sealant placed on the maxillary anterior teeth. White spot lesion formation was evaluated with standardized digital photographs at two timepoints, T1 (initial appointment before bonding), and T2 (12 months later, with brackets removed). The brackets were removed in order to facilitate an adequate photographic exam. Photographs were analyzed side-by-side at the conclusion of the study with the Enamel Decalcification Index (EDI). The location of WSLs were recorded by tooth type and by region. Oral hygiene was evaluated at T1 and T2.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pro Seal Sealant | Active Comparator | ProSeal Sealant was applied to the facial surfaces of the maxillary anterior teeth (canine to canine) |
|
| MI Varnish | Active Comparator | MI Fluoride Varnish was applied to the maxillary anterior teeth (canine to canine) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pro Seal Sealant | Device | Sealant was reapplied every 3 months |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Enamel Decalcification Index | Extent and severity of white spot lesion formation | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Location of White Spot Lesions | Mesial, Distal, Incisal or Gingival Region | 12 months |
| Most Common Tooth for White Spot Formation | Maxillary Canine, Lateral, or Central Incisor |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Peter Buschang, PhD | Texas A&M University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Texas A&M University College of Dentistry | Dallas | Texas | 75246 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 8181546 | Result | Banks PA, Richmond S. Enamel sealants: a clinical evaluation of their value during fixed appliance therapy. Eur J Orthod. 1994 Feb;16(1):19-25. doi: 10.1093/ejo/16.1.19. | |
| 5264376 | Result | Turesky S, Gilmore ND, Glickman I. Reduced plaque formation by the chloromethyl analogue of victamine C. J Periodontol. 1970 Jan;41(1):41-3. doi: 10.1902/jop.1970.41.41.41. No abstract available. |
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Individual results of the study will not be shared.
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Sep 19, 2025 | Oct 8, 2025 | 1 |
single center, parallel, randomized clinical trial
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| MI Varnish |
| Device |
Fluoride varnish was applied every 4-6 weeks |
|
| 12 Months |
| Oral Hygiene Status | Measurement of plaque accumulation on maxillary teeth | 12 Months |
| Sex Differences | Male versus Female | 12 Months |