Comparison of MI Paste Plus and Resin Infiltration in White Spot Lesions Following Orthodontic Tr… (NCT05733676) | Clinical Trial Compass
RecruitingNot Applicable
Comparison of MI Paste Plus and Resin Infiltration in White Spot Lesions Following Orthodontic Treatment
Canada62 participantsStarted 2023-05-30
Plain-language 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.
Who can participate
Age range
12 Years – 21 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Remineralization as assessed by the Enamel Decalcification Index (EDI) score with values 0-3 in each of the four tooth surfaces
Timeframe: 3 years
2
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