Recruiting

MI Paste Plus vs. Resin Infiltration

Sponsor:

University of Alberta

Code:

NCT05733676

Conditions

White Spot Lesions

Orthodontic Appliance Complication

Caries Arrested

Smooth Surface Caries

Eligibility Criteria

Sex: All

Age: 12 - 21

Healthy Volunteers: Accepted

Interventions

Resin infiltration

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

Study Details

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

Study ID

NCT05733676

Start date

May 30, 2023

Status verified date

Jun, 2026

Completion date

Oct 1, 2028

Anticipated

Primary completion date

Mar 1, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 12 - 21

Healthy Volunteers: Accepted

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Design

Enrollment

62 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Resin Infiltration

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

active comparator: Casein Phosphopeptide (CPP) - Amorphous Calcium Phosphate (ACP) - Fluoride

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

Interventions

Resin infiltration

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

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

Primary outcome measure

  • Remineralization as assessed by the Enamel Decalcification Index (EDI) score with values 0-3 in each of the four tooth surfaces [ Time Frame: 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 [ Time Frame: 3 years ]

Central Contacts and Locations

Central contacts

Ida M Kornerup, DMD, MEd

780 492 7100kornerup@ualberta.ca

Nancy Abdelhay, DMD, PhD

780 492 7100abdelhay@ualberta.ca

Locations

KAYE Edmonton Clinic

Recruiting

Edmonton, Alberta, Canada, T6G 1Z1

Contacts

Doris Lunardon, DDS

780 407 5572lunardon@ualberta.ca

Melanie Chouinard

780 407 5552mchouina@ualberta.ca

More Information

Sponsor

University of Alberta

Last update posted

Jun 30, 2026

Last verified

Jun, 2026

Keywords

  • White spot lesion
  • caries
  • arrested
  • orthodontic

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Alberta on 2026-06-30.