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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 years
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
I am between 12-21 years old and had braces for 12-36 months.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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
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
Find a Location
Who is running the clinical trial?
University of AlbertaLead Sponsor
889 Previous Clinical Trials
385,115 Total Patients Enrolled
Ida M Kornerup, DMD, MEdPrincipal InvestigatorUniversity of Alberta
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I haven't used any dental treatments besides regular toothpaste in the last 3 months.I am between 12-21 years old and had braces for 12-36 months.I have a health, dental, or mental condition.You should have at least one white spot on the front teeth after braces are removed. The spot should be visible whether the teeth are dry or wet.You have significant oral hygiene issues, rated 3.1 or higher on a scale from 0 to 6.You have mild to moderate plaque buildup and not-so-good oral hygiene, with a simplified Oral Hygiene Index score between 1.3 and 3.0.I have fillings or crowns on the front of my top or bottom front teeth.I have underdeveloped or abnormal front teeth.I had white spots on the front of my teeth before starting braces.
Research Study Groups:
This trial has the following groups:- Group 1: Resin Infiltration
- Group 2: Casein Phosphopeptide (CPP) - Amorphous Calcium Phosphate (ACP) - Fluoride
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Could I potentially become involved in this experiment?
"Eligibility requirements for this medical trial include having white spot lesions and being between 12 to 21 years of age. A total of 62 individuals will be accepted into the study."
Answered by AI
Does this study accept participants who are 18 or older?
"Candidates for this clinical trial must fall within the age range of 12 to 21. Additionally, there are 20 trials available for those under 18 and 63 additional studies available for seniors aged 65 or older."
Answered by AI
Is this clinical research project currently accepting participants?
"According to information published on clinicaltrials.gov, this research study is currently not accepting applications from prospective participants; it was initially posted on the 1st of March 2023 and last updated 8th of February 2023. Despite being closed for recruitment at present, 76 other trials are in need of patients right now."
Answered by AI
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