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Clinical Trials/NCT05733676
NCT05733676RecruitingNot Applicable

Comparison of MI Paste Plus and Resin Infiltration in Improvement of White Spot Lesions Following Fixed Orthodontic Treatment: A Randomized Controlled Trial

University of Alberta2 sites in 1 country62 target enrollmentStarted: May 30, 2023Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Enrollment
62
Locations
2
Primary Endpoint
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

Study Overview

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.

Detailed Description

White spot lesion (WSL) is the first clinical sign of enamel caries that presents itself as a milky-white opacity non-cavitated when located on smooth surfaces. These surfaces are rougher than sound enamel, and they can be arrested or progressed. WSLs are more commonly seen on the outer surface of teeth after orthodontics treatment. Causing unaesthetic appearance on the anterior teeth and increasing chance of dental caries progression.

Different interventions have been introduced to manage WSL as preventing demineralization and biofilm formation, and promoting remineralization with fluoride varnish, casein phosphopeptides-amorphous calcium phosphate (CPP-ACP)- a nano-complex derived from milk casein that significantly increases salivary calcium and phosphate levels9 .

The remineralization of enamel subsurface lesions by CPP-ACP has been demonstrated in several in vitro studies. The potential of CPP-ACP to prevent enamel demineralization and promote lesion remineralization has also been successfully demonstrated in human in situ models. In the presence of fluoride, CPP-ACP has been shown to promote the formation of fluorapatite-like minerals deep in the subsurface lesion. Clinical studies evaluating the effect of CPP-ACP/ACFP on WSLs after debonding report significant regression of WSL numbers, size, and activity in comparison to fluoride or substances without fluoride. Consequently, CPP-ACP has been incorporated into minimally invasive products for the remineralization of WSLs. Nevertheless, other studies state significant change showing improvements in WSLs with remineralization products but no superiority of CPP-ACP .

Multiple studies have tested the efficacy of CPP-ACP on post-orthodontic WSLs but only a limited number of prospective clinical studies have examined the effect of CPP-ACP and fluoride + etch on WSLs developed during orthodontic treatment. It is during therapy with fixed appliances that patients are most susceptible to forming WSLs and WSLs are most active. Recently, treatment with resin infiltration has been developed by the dentistry equipe at Charité University of Berlin, Germany and was first proposed to halt the interproximal early stage non-cavitated caries lesions. It represents a new concept in dentistry that offers valuable clinical applicability for clinicians and high acceptance by patients and is an alternative method to treat early caries lesions that are not expected to remineralize or arrest by non-invasive measures when the infiltration is performed with low-viscosity light-curing resins.

The refractive index (RI) of enamel lesions is effective in arresting and stabilizing the progress of WSLs. Paris et al noted that lesions infiltrated by resin infiltration took on the appearance of the surrounding sound enamel masking the whitish appearance by filling the lesion's body with resin, which results in a rise of the refractive index (RI) of the lesion from 1-1. to 1.42-1.44 with resin infiltration, which is closer to a healthy enamel (1.62-1.63). Thus, a restoration with enamel-like optical characteristics is obtained. This technique is considered micro-invasive and may bridge the gap between the non-invasive and minimally invasive treatment of WSLs, postponing the need for a restoration as long as possible.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Double (Participant, Outcomes Assessor)

Masking Description

Double, Participant and Outcomes Assessor

Eligibility Criteria

Ages
12 Years to 21 Years (Child, Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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

Arms & Interventions

Resin Infiltration

Active Comparator

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

Intervention: Casein Phosphopeptide (CPP) - Amorphous Calcium Phosphate (ACP) - Fluoride (Device)

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

Intervention: Casein Phosphopeptide (CPP) - Amorphous Calcium Phosphate (ACP) - Fluoride (Device)

Outcomes

Primary Outcomes

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

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.

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

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.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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