EFFECTIVENESS of WATER FLOSS in PLAQUE REMOVAL and PREVENTION of WHITE SPOT LESIONS in ORTHODONTI… (NCT06752291) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
EFFECTIVENESS of WATER FLOSS in PLAQUE REMOVAL and PREVENTION of WHITE SPOT LESIONS in ORTHODONTIC PATIENTS: a RANDOMISED CONTROLLED CLINICAL TRIAL
Malaysia32 participantsStarted 2024-04-01
Plain-language summary
This clinical trial aims to learn if water floss is as efficient as other interdental cleaning tools and can prevent plaque accumulation and white spot lesions (WSLs) in orthodontic patients. It will also assess the impact of water floss on gingival health. The main questions it aims to answer are:
* Which interdental cleaning tools reduce plaque accumulation and improve gingival health in orthodontic patients?
* Which interdental cleaning tools lower the incidence of white spot lesions compared to conventional oral hygiene practices? Researchers will compare the oral health of Orthodontic patients' using different interdental cleaning tools to evaluate their effectiveness in improving oral health outcomes.
Participants will:
* Be assigned to one of two groups:
* Intervention group: instructed to use water flossing in their oral hygiene routine.
* Control group: instructed to use dental floss and interdental brush in their oral hygiene routine.
* Participate for 8 months, with clinical assessments for plaque and gingival health and photographic documentation for WSLs at baseline (T0), and at 2-month intervals (T1, T2, T3, and T4).
Who can participate
Age range
18 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:
Mild to moderate crowding upper and lower arch 18 years old and above Patients with BPE score 0/1 Stay in areas with the same concentration of water fluoridation No history of orthodontic treatment before Able to read and understand in English or Bahasa Melayu Fit and healthy Patients with upper and lower fixed appliance
Exclusion Criteria:
Severe crowding Less than 18 years old Patients with BPE score more than 2 Patients with systemic disease and syndromic Syndromic patients (eg; Cleft lip and palate) Unable to read and understand in English or Bahasa Melayu Clinically missing teeth (impacted/congenitally missing) Patients with segmental fixed appliances in single or both arches.
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
White spot lesion
Timeframe: From enrollment to the end of study at 8 months
2
Dental plaque
Timeframe: From enrollment to the end of study at 8 months
3
Gingival health
Timeframe: From enrollment to the end of study at 8 months