Texas A&M University College of Dentistry
Dallas, Texas, 75246, United States
NCT Number: NCT04560478
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.
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Notify Me12 year–17 year
All sexes
Interventional
Not applicable
Dallas, Texas, 75246, United States
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Sealant was reapplied every 3 months
Fluoride varnish was applied every 4-6 weeks
Time frame: 12 months
Extent and severity of white spot lesion formation
Time frame: 12 months
Mesial, Distal, Incisal or Gingival Region
Time frame: 12 Months
Maxillary Canine, Lateral, or Central Incisor
Time frame: 12 Months
Measurement of plaque accumulation on maxillary teeth
Time frame: 12 Months
Male versus Female
Texas A&M University
Other
THE EFFICACY OF MI VARNISH VERSUS PRO SEAL SEALANT ON PREVENTION OF WHITE SPOT LESIONS IN ORTHODONTIC PATIENTS: A RANDOMIZED CLINICAL TRIAL
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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