Rapid Maxillary Expansion Related Oxidative Stress and Periodontal Results

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

• Ages 11 to 16 years
• All sexes
• No healthy volunteers
• Child

About this study

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

Conditions

Maxillary Expansion

Being tested

Periodontal measurements (plaque index, gingival index and probing pocket depth scores ), Biochemical Sample Supply (Collection of serum and saliva samples), Rapid maxillary expansion with Hyrax appliance

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

• Periodontal measurements (plaque index, gingival index and probing pocket depth scores )Other

  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.

• Biochemical Sample Supply (Collection of serum and saliva samples)Other

  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.

• Rapid maxillary expansion with Hyrax applianceProcedure or surgery

  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.

What is being measured

The primary outcome is the main question the study is designed to answer.

1. Biochemical analyses - 8-OHdG

   8-OHdG is the most frequently encountered and best known mutagenicity of more than 20 oxidative base damage products of ROS in DNA. Since it is easily detected in living cells and body fluids, it is the most commonly used oxidative DNA damage marker.

   Serum and saliva levels will be measured using a suitable ELISA kit (Cayman Chemical DNA/RNA Oxidative Damage ELISA Kit Item No.589320) according to the manufacturer's instructions. The measurement principle is as follows: It is based on the competition between 8-OHdG from the sample and 8-OHdG-acetylcholinestarase conjugate (8- OHdG Tracer) from the kit for a limited amount of 8-OHdG monoclonal antibody covering the plate well. The colour intensity measured spectrophotometrically at 410 nm is directly proportional to the tracer and inversely proportional to the amount of free 8-OHdG in the sample.

   Measured: 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)

   Total Oxidative Status (TOS) is a current method used to detect lipid peroxidation and oxidative stress. TOS is considered to be a superior method compared to other methods due to the impracticality of measuring different oxidant molecules individually and the inability to fully reflect the interaction of oxidant molecules with each other. Total Antioxidan Status (TAS) is a biochemical parameter obtained as a result of the sum of the antioxidant capacities of all antioxidants in the biological samples examined. Oxidative Stress Index (OSI) is a proportional value obtained by dividing TOS by TAS. It is directly affected by total oxidative and antioxidant status and reveals the final oxidative status in a practical and understandable way.

   OSI value was calculated according to the following formula. OSI = TOS (mmol H2O2 Equiv./L) / TAS (mmol Trolox Equiv./L) x 100

   Measured: 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)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1. First posted22 Apr 2025
2. Study start10 Jan 2016
3. Primary completion10 Mar 2016
4. Study completion10 Aug 2016

Resources

• Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
• Other trials for Maxillary ExpansionStudies of the same condition, open and under way.
• What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.