The Effect of Different Remineralizing Agents on White Spot Lesions and Dental Plaque During Orth… (NCT04788550) | Clinical Trial Compass
UnknownNot Applicable
The Effect of Different Remineralizing Agents on White Spot Lesions and Dental Plaque During Orthodontic Retention
Malaysia30 participantsStarted 2021-03-17
Plain-language summary
Dental caries is a decay process that breaks down the tooth. The earliest clinical signs of active dental caries is seen as 'white spot lesions' (WSLs). WSLs causes porosity below the tooth surface as a result of demineralization that gives the lesion a milky white appearance.
Many WSLs persevere even a decade after orthodontic appliance removal and remain a cosmetic problem. After removal of fixed appliances, a considerable improvement of WSLs can be seen during the first 6-24 months, but the degree of improvement varies between individuals.
Two common bacteria in dental plaque causes caries: Streptococcus mutans (SM) and Lactobacillus acidophilus (LA) in the plaque contributes to the initiation and progression of caries, respectively.
A major strategy suggested to deal with existing WSL after debond is to facilitate remineralisation using remineralising agents that contain fluoride. This can be from daily use of fluoridated toothpastes or having additional dose of fluoride application. Certain agents also contain casein phosphopeptide-stabilize amorphous calcium phosphate (CPP-ACP) that is believed to have an antibacterial and buffering effect on plaque and interfere the growth and adherence of bacteria.
Who can participate
Age range
16 Years – 40 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:
* Subjects on multibracket fixed appliance treatment
* Subjects with 2 or more bracketed surfaces with labial subsurface WSLs from
* upper right permanent canine (13) to upper left permanent canine (23) with an ICDAS II score of 1 and 2 will be selected.
* Indicated for thermoform or vacuum formed retainers on the upper arch.
Exclusion Criteria:
* Systemic diseases or any physical anomalies.
* Subjects with intention to move out from Klang Valley area for the next 1.5 years.
* Periodontal diseases (pocket depth of more than 3mm).
* Smoker.
* Severe fluorosis or any enamel abnormalities.
* Antimicrobial agents or antibiotic therapy within the past 3 months.
* Orthognathic surgery cases, cleft lip and palate.
* Single arched lower fixed orthodontic treatment.
* Milk protein and benzoate preservatives (a common preservatives) allergies.
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
ICDAS score of the white spot lesion.
Timeframe: 18 months
2
Optical changes (refractive index) of the white spot lesion.
Timeframe: 18 months
3
Patient perception of the WSL
Timeframe: 18 months
4
Dental plaque total bacterial count, Streptococcus count, Lactobacillus count.