Comparison of MI Paste Plus and Resin Infiltration in White Spot Lesions Following Orthodontic Treatment
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age12-21
SponsorUniversity of Alberta
About this trial
Dental cavities are among the most frequent diseases that affect teeth, particularly in patients who are treated with braces due to the difficulty in maintaining good oral hygiene in the presence of the mouth appliances. The white spot lesion (WSL) is the first clinical sign of cavities that presents itself as a milky-white opacity when located on the front face of the tooth. The aim to manage these early lesions focuses on promoting natural remineralization and preventing further demineralization. Various materials have been introduced for management of WSLs including MI paste and MI paste combined with fluoride (MI paste plus). Recently, a new material called resin infiltration has been found to treat these lesions with high esthetic results and great performance. According to the few numbers of in-vivo studies investigating the effectiveness of remineralization products, the aim of the current study is to clinically compare the outcome of the resin-infiltration and etching + MI paste plus to stop and improve the appearance of the WSL on front teeth in patients after treatment with braces.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Individuals in the age range of 12-21 years who had undergone fixed orthodontic appliance therapy for a duration of 12-36 months.
Should have at least one white spot lesion on the labial surface of either maxillary or mandibular anterior teeth after debonding. Lesion visible with or without drying the lesion surface.
Patients with mild to moderate plaque accumulation. Fair oral hygiene. With a simplified Oral Hygiene Index of no more than 1.3-3.0
Disqualifiers
Poor oral hygiene Simplified Oral Hygiene Index of 3.1-6.0 or more
Patients with hypoplasia or any developmental defects on the buccal of upper or lower incisors
Patients with any restorations on the buccal of upper or lower incisors
Patients that have presented WSL on the buccal of upper or lower incisors before orthodontic treatment was initiated.
Trial design
Design model
Parallel
Treatments tested in this trial
Resin infiltration
DeviceBase line treatment of white spot lesions in smooth surface with Resin infiltration -Icon + etch, DMG, Germany.
Casein Phosphopeptide (CPP) - Amorphous Calcium Phosphate (ACP) - Fluoride
DeviceBase line treatment of white spot lesions in smooth surface with MI paste plus + etch , GC corporation, Germany, Europe
Treatment groups
62 Participants
are divided into 2 treatment groupsGroup A: Resin InfiltrationActive comparator 2 interventions
Group B: Casein Phosphopeptide (CPP) - Amorphous Calcium Phosphate (ACP) - FluorideActive comparator 2 interventions
Trial outcomes
Primary outcomes
1
Remineralization as assessed by the Enamel Decalcification Index (EDI) score with values 0-3 in each of the four tooth surfaces
Enamel decalcification index (EDI) score with values 0-3 in each of the four facial zones including mesial, distal, gingival, and occlusal surfaces around the approximate location of the debonded bracket it will represent the decalcification level based on clinical visual assessment of the tooth. The values will be recorded at baseline, 3, 6, 12,18 months. Tooth surfaces completely covered by gingiva or bonding material will be excluded. International caries detection and assessment system (ICDAS) with values 0-6 will be assigned to each tooth surface around the orthodontic bracket.
Time frame
3 years2
Satisfaction evaluation of the white spot lesion (WSL) as assessed by a Visual Analog Scale (VAS) from 0 mm no change to 100 mm completely changed
Intraoral frontal views will be taken at, 3, 6,12 and 18 months after completion of orthodontic treatment. This digital photography will be calibrated following protocols to standardize magnification, shade, and color. The images will be cropped to include the 4 incisors. Two independent, blinded panels will rate the WSL change using a visual analog scale (VAS) from 0 mm no change to 100 mm completely changed. The order of the participants will be shuffled so the bias resulted from examiner bias will be eliminated. The median value of the VAS will be selected as the representation for the percentage of change.
Time frame
3 yearsSponsors and contacts
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Source ClinicalTrials.gov