White Spot Lesion
Conditions
Keywords
Oral Hygiene, Orthodontics, White spot lesion, enamel decalcification
Brief summary
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.
Detailed description
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.
Interventions
DEVICEPro Seal Sealant
Sealant was reapplied every 3 months
DEVICEMI Varnish
Fluoride varnish was applied every 4-6 weeks
Sponsors
Texas A&M University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Intervention model description
single center, parallel, randomized clinical trial
Eligibility
Sex/Gender
ALL
Age
12 Years to 17 Years
Healthy volunteers
Yes
Inclusion criteria
* no significant medical history * no underlying medical problems such as Sjogren's Syndrome or conditions requiring more than 2 medications (to prevent bias of possible dry mouth) * less than 17 years old at the start of orthodontic treatment, * fully erupted permanent maxillary canines and incisors, starting fixed orthodontic treatment * ability to come to appointments every 4-6 weeks.
Exclusion criteria
* professional fluoride application in the last 3 months * allergy to milk * untreated cavitated lesions * heavy initial fluorosis * dry mouth * pregnancy * any illness/condition that the investigators felt would affect the study outcome.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Enamel Decalcification Index | 12 months | Extent and severity of white spot lesion formation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Location of White Spot Lesions | 12 months | Mesial, Distal, Incisal or Gingival Region |
| Most Common Tooth for White Spot Formation | 12 Months | Maxillary Canine, Lateral, or Central Incisor |
| Oral Hygiene Status | 12 Months | Measurement of plaque accumulation on maxillary teeth |
| Sex Differences | 12 Months | Male versus Female |
Countries
United States
Outcome results
None listed