Oxidative Stress and Antioxidant Responses During Rapid Maxillary Expansion: A Controlled Clinical Study

NCT07695584 | Completed

• 1 other identifier: Oxidative Stress Expansion
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Transverse Maxillary Deficiency; Oxidative Stress

Keywords

Rapid maxillary expansion; Gingival crevicular fluid; Oxidative stress

Outcome Measures

Primary Outcomes (1)

• Change in gingival crevicular fluid malondialdehyde level

  Malondialdehyde in gingival crevicular fluid was assessed using a thiobarbituric acid reactive substances method and normalized to total protein concentration. Higher values indicate greater local lipid peroxidation.

  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.

Secondary Outcomes (3)

• Change in gingival crevicular fluid reduced glutathione level

  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.

• Change in gingival crevicular fluid glutathione peroxidase activity

  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.

• Change in gingival crevicular fluid vitamin C level

  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.

Study Arms (2)

No intervention

NO INTERVENTION

Age- and sex-matched participants who did not receive orthodontic treatment during the observation period. Participants underwent the same periodontal examinations and gingival crevicular fluid sampling schedule as the intervention group.

Expansion

EXPERIMENTAL

A tooth-borne rapid maxillary expansion appliance with bands cemented to the maxillary permanent first molars and palatal bars connecting the premolar and molar regions to the expansion screw. The screw was activated twice daily, corresponding to approximately 0.5 mm of expansion per day, until the clinically planned expansion was achieved. The screw was subsequently stabilized with composite resin and the appliance was maintained during the retention period.

Procedure: Expansion group

Interventions

Expansion group PROCEDURE

A tooth-borne rapid maxillary expansion appliance with bands cemented to the maxillary permanent first molars and palatal bars connecting the premolar and molar regions to the expansion screw. The screw was activated twice daily, corresponding to approximately 0.5 mm of expansion per day, until the clinically planned expansion was achieved. The screw was subsequently stabilized with composite resin and the appliance was maintained during the retention period.

Expansion

Eligibility Criteria

• Age: 10 Years - 13 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• IRCCS Ospedale San Raffaele: lead
• Università Vita-Salute San Raffaele: collaborator

Study Sites (1)

Izmir Democracy University

Izmir, 35140, Turkey (Türkiye)

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: July 6, 2026
• First Posted: July 10, 2026
• Study Start: March 1, 2011
• Primary Completion: May 31, 2011
• Study Completion: June 30, 2012
• Last Updated: July 10, 2026

Record last verified: 2026-07

Locations

TU (1)