NCT06937775

Rapid Maxillary Expansion Related Oxidative Stress and Periodontal Results

Rapid Maxillary Expansion Related Sutural and Dentoalveolar Changes Provoke Salivary Oxidative Stress: A Biochemical Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 35 (actual)
• Sponsor: Recep Tayyip Erdogan University Training and Research Hospital · Academic / Other
• Sex: All
• Age: 11 Years – 16 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Maxillary Expansion

Interventions

Type	Name	Description
OTHER	Periodontal measurements (plaque index, gingival index and probing pocket depth scores )	Plaque index (PI), gingival index (GI) and probed pocket depth (PPD) scores will be recorded at T0, T1, T2 and T3 assessment periods to evaluate the periodontal status and oral care effectiveness of the participants. PPD is the distance between the gingival margin and the sulcus base. Measurements will be made at 6 different sites (mesio-vestibular, vestibular, disto-vestibular, mesio-oral, oral, disto-oral) of each tooth using a Williams periodontal probe (Hu Friedy, Chicago, Illinois, USA). During the measurements, care will be taken to position the probe as parallel as possible to the long axis of the tooth and not to apply excessive force.
OTHER	Biochemical Sample Supply (Collection of serum and saliva samples)	Serum and saliva samples will obtained from all individuals included in the study at T0, T1, T2 and T3 for biochemical analyses. For standardisation purposes, blood samples will be collected from the antecubital fossa with the patients in a sitting position. After resting for 30 minutes (min) at room temperature, the samples will be centrifuged (4ºC at 3000 rpm for 5 min) and serum samples will be obtained. The samples will be transferred into eppendorf tubes and stored in the freezer (-80ºC) until the study day. Sampling will be performed early in the morning. Participants will be warned not to consume anything other than water for the last 12 hours and not to brush their teeth that morning. Individuals will be left with their mouths open for 5 min to allow saliva to accumulate at the floor of the mouth. Unstimulated saliva samples accumulated at the floor of the mouth will be collected and transferred to eppendorf tubes.
PROCEDURE	Rapid maxillary expansion with Hyrax appliance	Rapid maxillary expansion (RME) is the most commonly preferred treatment of skeletal jaw stenosis in the transversal direction. Bilateral anchorage is the process of increasing the transversal dimension of the midpalatal suture (sutura palatina media) by applying strong tensile forces in the lateral direction to the dentoalveolar structures of the teeth and/or palatal bone. The primary goal of treatment is to provide orthopedic movement through sutural separation.

Timeline

• Start date: 2016-01-10
• Primary completion: 2016-03-10
• Completion: 2016-08-10
• First posted: 2025-04-22
• Last updated: 2025-07-24