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Resin Infiltration vs. CPP-ACP-Fluoride for White Spot Lesions

N/A

Recruiting

Led By Ida M Kornerup, DMD, MEd

Research Sponsored by University of Alberta

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Individuals in the age range of 12-21 years who had undergone fixed orthodontic appliance therapy for a duration of 12-36 months

Be younger than 65 years old

Must not have

Patients with any restorations on the buccal of upper or lower incisors

Patients with hypoplasia or any developmental defects on the buccal of upper or lower incisors

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 years

Awards & highlights

No Placebo-Only Group

Summary

This trial looks at treating cavities in patients with braces, comparing the effectiveness of two materials for remineralization and improving the appearance of white spot lesions.

Who is the study for?

This trial is for young people aged 12-21 who've had braces for 1-3 years and have white spots on their front teeth after the braces come off. They should have decent oral hygiene but haven't used any special tooth treatments in the last three months, except regular toothpaste.

What is being tested?

The study compares two ways to treat early signs of cavities that show up as white spots after wearing braces: a paste called MI Paste Plus and a new method called resin infiltration. The goal is to see which one works better at stopping and improving these spots.

What are the potential side effects?

Potential side effects are not explicitly listed, but since MI Paste Plus contains fluoride and casein (a milk protein), it could cause issues for those with allergies to milk products or concerns about fluoride use.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 12-21 years old and had braces for 12-36 months.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have fillings or crowns on the front of my top or bottom front teeth.

Select...

I have underdeveloped or abnormal front teeth.

Select...

I had white spots on the front of my teeth before starting braces.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Remineralization as assessed by the Enamel Decalcification Index (EDI) score with values 0-3 in each of the four tooth surfaces

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Active Control

Group I: Resin InfiltrationActive Control2 Interventions

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

Group II: Casein Phosphopeptide (CPP) - Amorphous Calcium Phosphate (ACP) - FluorideActive Control2 Interventions

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

0 / 4Eligibility criteria met