Clinical trial NCT06937775: Rapid Maxillary Expansion Related Oxidative Stress and Periodontal Results
Official title: Rapid Maxillary Expansion Related Sutural and Dentoalveolar Changes Provoke Salivary Oxidative Stress: A Biochemical Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Maxillary Expansion
Lead sponsor: Recep Tayyip Erdogan University Training and Research Hospital
Sponsor class: OTHER
First posted: 2025-04-22
Enrollment: 35
Sex: ALL
Minimum age (years): 11
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Biochemical analyses - 8-OHdG
timeFrame: 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)
measure: Biochemical analyses - Oxidative Stress Index (TOS/TAS=OSI)
timeFrame: 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)
Secondary outcomes:
measure: Clinical Periodontal Assessments-plaque index
timeFrame: 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)
measure: Clinical Periodontal Assessments-gingival index
timeFrame: 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)
measure: Clinical Periodontal Assessments-probed pocket depth (PPD)
timeFrame: 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)
Other outcomes:
Locations:
Study officials:
References: