Rapid Maxillary Expansion Related Oxidative Stress and Periodontal Results (NCT06937775) | Clinical Trial Compass
CompletedNot Applicable
Rapid Maxillary Expansion Related Oxidative Stress and Periodontal Results
35 participantsStarted 2016-01-10
Plain-language summary
The aim of this study was to investigate the effects of rapid maxillary expansion on local and systemic oxidative stress levels. Thirty-five volunteer patients (17 females and 18 males) who needed rapid maxillary expansion will be included in the study. Serum and saliva samples will be collected from each patient during four different periods: a week before the treatment (T0), on the day of sutural separation (T1), at the end of the active expansion period (T2), and after the completion of a 3-month retention period (T3). To evaluate the patients' periodontal status, plaque index, gingival index, and probing pocket depth scores will be recorded for each period. 8-hydroxydeoxyguanosine (8-OHdG), total oxidative status (TOS), total antioxidant capacity (TAS), and oxidative stress index (OSI) biomarkers will be evaluated to determine the local and systemic oxidative stress levels.
Who can participate
Age range
11 Years – 16 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:
* Being between 11-15 years of age,
* Having an indication for maxillary expansion due to maxillary stenosis,
* Being highly cooperative, performing adequate oral care,
* Being periodontally healthy,
* Not having cleft lip and/or palate anomalies,
* Not having any systemic disease,
* Not having used any medication including antibiotics and anti-inflammatory drugs in the last 6 months,
* Not being substance addicted and not smoking.
Exclusion Criteria:
* Having inadequate oral hygiene
* Being periodontally unhealthy
* Having cleft lip and/or palate anomalies,
* Having any systemic disease,
* Having used any medication including antibiotics and anti-inflammatory drugs in the last 6 months,
* Being substance addicted and not smoking.
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
Biochemical analyses - 8-OHdG
Timeframe: a week before the treatment (T0), 5-7 days after activation (T1), 3rd week (T2), and after the completion of a 3-month retention period (T3)
2
Biochemical analyses - Oxidative Stress Index (TOS/TAS=OSI)
Timeframe: a week before the treatment (T0), 5-7 days after activation (T1), 3rd week (T2), and after the completion of a 3-month retention period (T3)
Trial details
NCT IDNCT06937775
SponsorRecep Tayyip Erdogan University Training and Research Hospital