Oxidative Stress and Antioxidant Responses During Rapid Maxillary Expansion: A Controlled Clinica… (NCT07695584) | Clinical Trial Compass
CompletedNot Applicable
Oxidative Stress and Antioxidant Responses During Rapid Maxillary Expansion: A Controlled Clinical Study
Turkey (Türkiye)28 participantsStarted 2011-03-01
Plain-language summary
Rapid maxillary expansion is an orthopedic treatment used to correct transverse maxillary deficiency in growing patients. Mechanical forces generated during expansion may induce local biological responses, including changes in oxidative stress and antioxidant defense mechanisms.
This prospective, non-randomized, controlled pilot study evaluated changes in oxidative and antioxidant biomarkers in gingival crevicular fluid during rapid maxillary expansion and the early retention period. Twenty-eight participants aged 10 to 13 years were included: 14 patients undergoing rapid maxillary expansion and 14 age- and sex-matched untreated controls.
Gingival crevicular fluid samples and periodontal measurements were collected at six corresponding time points. Malondialdehyde, reduced glutathione, glutathione peroxidase, and vitamin C were measured. The study aimed to characterize local biochemical changes associated with the treatment period and to compare their longitudinal patterns with those observed in untreated controls.
Who can participate
Age range
10 Years – 13 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:
* Age between 10 and 13 years.
* Good general health.
* Fully erupted maxillary premolars.
* Healthy periodontal status, with probing depth of 3 mm or less.
* For the intervention group, a clinical indication for rapid maxillary expansion.
* For the control group, no orthodontic treatment planned during the observation period.
* Ability to comply with the clinical examination and gingival crevicular fluid sampling schedule.
* Written informed consent from the participant's parent or legal guardian and assent from the participant, where applicable.
Exclusion Criteria:
* Systemic disease.
* Current medication use that could influence periodontal, inflammatory, or oxidative status.
* Active periodontal disease.
* Probing depth greater than 3 mm.
* Inability to comply with the oral hygiene protocol or study visits.
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
Change in gingival crevicular fluid malondialdehyde level
Timeframe: Baseline; 24 hours after appliance placement; 7 days after appliance placement; after 7 days of active expansion; after 14 days of active expansion; and after 3 months of retention.