Using Probiotics to Improve Oral Hygiene During Orthodontic Treatment (NCT06641960) | Clinical Trial Compass
CompletedNot Applicable
Using Probiotics to Improve Oral Hygiene During Orthodontic Treatment
Syria50 participantsStarted 2023-03-05
Plain-language summary
Fifty patients needing non-extraction-based metallic orthodontic treatment will be divided randomly into the probiotic group and the control group. In each group, they will brush their teeth regularly while receiving orthodontic treatment. Only the probiotic group will take probiotic tablets for six months.
Clinical parameters will be assessed before and during orthodontic treatment and after 3 and 6 months during treatment.
Who can participate
Age range
18 Years – 25 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
. Adult healthy male and female patients aged 18-25 years.
. Patients eligible for full arch upper and lower fixed labial orthodontic appliance treatment and molar band.
. Patients with malocclusion class I, II, or III without crowding on the anterior teeth.
. Permanent occlusion and existence of all the upper and lower teeth (except third molars).
. Good oral and periodontal health:
Exclusion criteria
. Previous orthodontic treatment history.
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
The change in the plaque index
Timeframe: Time Frame: T0: immediately before applying the fixed appliance; T1: at three months; T2: at six months
2
The change in the gingival index
Timeframe: Time Frame: T0: immediately before applying the fixed appliance; T1: at three months; T2: at six months
3
The change in papillary bleeding index
Timeframe: Time Frame: T0: immediately before applying the fixed appliance; T1: at three months; T2: at six months
4
The change in the probing depth
Timeframe: Time Frame: T0: immediately before applying the fixed appliance; T1: at three months; T2: at six months
. Patients with any systemic disorder that could influence periodontal conditions or response to treatment (such as hypertension, diabetes, or immunological disorders).
. Patients were on systemic drugs, i.e., antibiotics, hypertensives, analgesics, hormonal drugs, sedatives, and anti-seizure medication, within three months before the baseline examination.
. Patients who were allergic to ingredients of the probiotics lozenges.
. Those undergoing periodontal treatment within three months before the baseline examination.