Comparison of MI Paste Plus and Resin Infiltration in White Spot Lesions Following Orthodontic Treatment

NCT05733676 | Recruiting DMC

• 1 other identifier: UAlberta-Pro00126739
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

White Spot Lesions; Orthodontic Appliance Complication; Caries Arrested; Smooth Surface Caries

Keywords

White spot lesion; caries; arrested; orthodontic

Outcome Measures

Primary Outcomes (2)

• 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.

  3 years

• 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.

  3 years

Study Arms (2)

Resin Infiltration

ACTIVE COMPARATOR

Resin infiltration of early intervention of caries lesion as a consequences of orthodontic treatment

Device: Resin infiltration; Device: Casein Phosphopeptide (CPP) - Amorphous Calcium Phosphate (ACP) - Fluoride

Casein Phosphopeptide (CPP) - Amorphous Calcium Phosphate (ACP) - Fluoride

ACTIVE COMPARATOR

Casein Phosphopeptide (CPP) - Amorphous Calcium Phosphate (ACP) - Fluoride early intervention of caries lesion as a consequences of orthodontic treatment

Device: Resin infiltration; Device: Casein Phosphopeptide (CPP) - Amorphous Calcium Phosphate (ACP) - Fluoride

Interventions

Resin infiltration DEVICE

Base line treatment of white spot lesions in smooth surface with Resin infiltration -Icon + etch, DMG, Germany.

Casein Phosphopeptide (CPP) - Amorphous Calcium Phosphate (ACP) - Fluoride; Resin Infiltration

Casein Phosphopeptide (CPP) - Amorphous Calcium Phosphate (ACP) - Fluoride DEVICE

Base line treatment of white spot lesions in smooth surface with MI paste plus + etch , GC corporation, Germany, Europe

Casein Phosphopeptide (CPP) - Amorphous Calcium Phosphate (ACP) - Fluoride; Resin Infiltration

Eligibility Criteria

• Age: 12 Years - 21 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.
• Patients that have received any re-mineralizing agent other than regular toothpaste during the last three months
• Patient with allergy to milk or any of their products
• Patient with any medical / oral or mental condition
• Patients or legal guardians that does not speak or read English

Sponsors & Collaborators

• University of Alberta: lead

Study Sites (1)

KAYE Edmonton Clinic

Edmonton, Alberta, T6G 1Z1, Canada

RECRUITING

Related Publications (38)

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• Choi YY, Lee DY, Kim YJ. Colorimetric evaluation of white spot lesions following external bleaching with fluoridation: An in-vitro study. Korean J Orthod. 2018 Nov;48(6):377-383. doi: 10.4041/kjod.2018.48.6.377. Epub 2018 Sep 14.

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Related Links

• Mi Paste Plus

MeSH Terms

Conditions

Heart Arrest

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Ida M Kornerup, DMD, MEd

  University of Alberta

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ida M Kornerup, DMD, MEd

CONTACT

780 492 7100; kornerup@ualberta.ca

Nancy Abdelhay, DMD, PhD

CONTACT

780 492 7100; abdelhay@ualberta.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Double, Participant and Outcomes Assessor
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The selected samples will be randomly allocated to two groups according to treatment received. Group I- Resin infiltration -Icon + etch, DMG, Germany. Group II- MI paste plus +etch , GC corporation, Germany, Europe,

Study Record Dates

• First Submitted: February 8, 2023
• First Posted: February 17, 2023
• Study Start: May 30, 2023
• Primary Completion: March 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: July 4, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)